+1-757-224-0177      Choose Language














Select Your Language


Medical Device and Drug Establishments Must Renew FDA Registrations by December 31, 2017

Medical device and drug establishments that produce and distribute products for sale within the United States are required to renew their U.S. Food and Drug Administration (FDA) registration annually.  Registrar Corp writes to remind the industries that registrations must be renewed for 2018 between October 1, 2017 and December 31, 2017.

Medical device establishments are required to designate an Official Correspondent for FDA communications in their registrations, while drug establishments must designate a Registrant Contact. Additionally, FDA requires all businesses located outside of the United States to appoint U.S. Agents.

Notices for Medical Device Establishments

While there are no major changes this year for drug establishments, medical device businesses should be aware of two important updates for their 2018 renewals:

  1. The 2018 user fee for medical device establishment registration is $4,624, a steep increase of $1242 from 2017. All medical device establishments that are required to register must pay this fee, regardless of whether or not they qualify as a small business for other medical device user fees.
  2. As mentioned previously, foreign medical device establishments are required to designate U.S. Agents in their registrations. The 2018 renewal period marks the first time that designated U.S. Agents must verify their agreement to serve this function.  Once an Agent’s information is entered into the FDA Unified Registration and Listing System (FURLS), the system will issue them a verification email.  Agents will have ten days accept their designation through FURLS.  If a device establishment’s U.S. Agent does not accept, a new Agent must be designated or the registration may be considered invalid for 2018.

Why Timely Renewal is Important

Failure to renew FDA registration can have adverse effects.  In the past, FDA has removed establishments from its database that did not renew, rendering their registration invalid.

FDA may issue a Warning Letter to a medical device or drug business that manufactures and distributes products for interstate commerce without a valid registration.  Shipments from foreign businesses may be denied entry into the United States if their registrations are not renewed.  It is prudent for businesses to complete timely registration renewal to help avoid preventable delays from costly detentions or other enforcement actions.

Registrar Corp can assist in the renewal of your medical device or drug establishment registration, facilitate payment of fees with FDA, and issue a third-party certificate that verifies your registration. Additionally, Registrar Corp can serve as your Official Correspondent or Registrant Contact and U.S. Agent.

Renew a Medical Device Establishment Registration here.

Renew a Drug Establishment Registration here.

Alternatively, you can call us at +1-757-224-0177 or you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

FDA Proposes Extension of Compliance Dates for Nutrition Facts Label Final Rules

On September 29, 2017, the U.S. Food and Drug Administration (FDA) proposed an extension of the compliance dates for the final rules mandating changes to the nutrition facts label for packaged food and beverages sold in the United States.  The extension would provide large food businesses (defined for these rules as grossing ten million dollars or more in annual sales) until January 1, 2020 to comply, while small businesses would have an additional year.

The rules, finalized in May 2016, do not solely consist of formatting changes, but also includes updates to serving sizes, daily values, and nutrient definitions. Despite the compliance deadlines appearing distant, the required changes are not superficial and may be time-consuming to implement. Registrar Corp urges food manufacturers to make proactive efforts now to update their product labeling and ensure compliance.

Why should I start making these changes now?

FDA proposed extending the deadlines due to covered parties’ concerns over complying in time with the initial deadline of July 2018.  They cited “issues regarding (among other things) the need for upgrades to labeling software, the need to obtain nutrition information from suppliers, the number of products that would need new labels, and a limited time for reformulation of products.” (Source)

Also of potential concern are the mandated updates to daily values for certain nutrients, such as dietary fiber, which will require many food manufacturers to readjust certain percent daily values on their labels. In addition, manufacturers will need to account for the daily values of vitamin D and potassium, which will be newly required on a product’s food label.

Many manufacturers will need to conduct laboratory tests for vitamin D, potassium, and other nutrients in their products.  As the deadlines approach, laboratories may see a high volume of food manufacturers requesting nutrient testing, leading to potential difficulties in scheduling tests as laboratories near capacity.  The cost of tests may also increase from high demand, and delays in obtaining results may occur.

Additionally, the daily value updates affect the eligibility for some food manufacturers to make claims associated with the nutrients on their labels. Nutrient content claims that state products are “high in” these nutrients or health claims that state products containing these nutrients “may reduce the risk of” certain diseases require the product in question to contain a specific percentage of the nutrient’s daily value consumed in one serving. In order to continue making these claims, some manufacturers may need to reformulate a product to match the required content of a certain nutrient.

For example, the new rules increase the daily reference value (DRV) of fiber from 25 to 28 grams.   FDA requires a product to contain 20% or more of the DRV per reference amount customarily consumed (RACC) in order to claim it is “high in fiber”.   A product with 5 grams of fiber per 25-gram RACC (20%) may claim to be “high in fiber” now, but once the new DRV of 28 grams takes effect, it will only contain about 18%.  The product may need to be reformulated with more fiber or the claim will need to be removed from the product labeling by the deadline.

Food labeling consists of several components. The earlier you begin, the more time you allot for the unexpected and improve the chance of avoiding a surplus of outdated labeling inventory.   If you do not want to navigate the changes on your own, Registrar Corp’s Regulatory Specialists are well-versed in FDA’s new food labeling rules and can transition your product labels for you.  In addition to a report explaining all our changes, you will receive a print-ready file of your revised label. For assistance, simply complete the form below or call us at +1-757-224-0177.

FDA Publishes FY 2018 User Fees for Medical Devices and Generic Drugs

The Medical Device User Fee Amendments (MDUFA) and the Generic Drug User Fee Amendments (GDUFA) were reauthorized on August 18, 2017 to be in effect through September 30, 2022.  The U.S. Food and Drug Administration (FDA) recently published the Fiscal Year (FY) 2018 fees for both MDUFA and GDUFA, introducing new types of fees and changes in rates from FY 2017.  All MDUFA and GDUFA fees begin on October 1, 2017.  To prepare medical device and drug businesses for these requirements, Registrar Corp outlines some notable changes to these amendments this year.

Fees for medical device establishments:

MDUFA requires a user fee from medical device establishments that register with FDA, as well as fees for certain applications, notifications, and other types of submissions filed on or after October 1, 2017.  Small businesses, defined for this regulation as having less than $100 million in gross sales during the most recent tax year, are eligible for reduced rates on most fees.  All other facilities are subject to a standard fee.  Some significant changes to MDUFA for this fiscal year are explained below.

Annual Establishment Registration – All medical device establishments that are required to register with FDA must pay the Annual Establishment Registration user fee.  The fee for this year is $4,624 (a $1,242 increase from FY 2017).  Unlike with other MDUFA fees, there is no waiver or reduction for small businesses.

510(k) Application – The standard fee for 510(k) applications sees an increase of $5,876 from the FY 2017 rate of $4,690 to $10,566.  Small businesses are required to pay $2642, facing an increase of $297 from the previous year.

De Novo Classification Application – New to the recent reauthorization of MDUFA is a fee for De Novo Classification applications.  A standard business that files an application following the start of FY 2018 is required to pay $93,229, while a small business pays $23,307.

Refer to the chart below for a detailed comparison of MDUFA’s fee changes between FY 2017 and FY 2018.

 

FY 2018 MDUFA Fees

Fee Type 2017 2018
Annual Establishment Registration $3,382 $4,624
Application Fees Standard Small Business Standard Small Business
510(k) $4,690 $2,345 $10,566 $2,642
513(g) $3,166 $1,583 $4,195 $2,098
De Novo Classification N/A N/A $93,229 $23,307
PMA, PDP, PMR, BLA $234,495 $58,624 $310,764 $77,691
panel-track supplement $175,871 $43,968 $233,073 $58,268
180-day supplement $35,174 $8,794 $46,615 $11,654
real-time supplement $16,415 $4,104 $21,753 $5,438
BLA efficacy supplement $234,495 $58,624 $310,764 $77,691
PMA annual report $8,207 $2,052 $10,877 $2,719
30-day-notice $3,752 $1,876 $4,972 $2,486

 

Fees for drug establishments:

GDUFA requires user fees for certain drug establishments producing active pharmaceutical ingredients (API) or finished dosage forms (FDF), the submission of certain drug master files (DMF) for generic drug products, and the submission of certain applications for generic human drug products.  New additions to GDUFA include abbreviated new drug application (ANDA) program fees and contract manufacturing organization (CMO) facility fees.  Some significant changes to GDUFA for this fiscal year are explained below.

Contract Manufacturing Organization Fees – For the recent GDUFA reauthorization, CMO facility fees apply to FDF facilities that are identified in at least one approved ANDA, but are not the ANDA holder or an owner or affiliate of the holder.  These fees are a two-thirds reduction of FDF facility fees for qualifying establishments.  Domestic CMOs are required to pay a user fee of $70,362, while foreign CMOs pay $85,362.

ANDA User Fees – The user fee for the submission of a single abbreviated new drug application (ANDA) has increased from $70,480 to $171,823.

ANDA Program Fees – Businesses holding ANDAs are now required to pay a user fee in relation to how many they hold.  The smallest ANDA program, with as little as one approved ANDA, begins with a user fee of $159,079.  A business holding between six and nineteen approved ANDAs is required to pay a medium program fee of $636,317. The largest program fee for businesses holding twenty or more approved ANDAs is $1,590,792.

Refer to the chart below for a detailed comparison of GDUFA’s fee changes between FY 2017 and FY 2018.

 

FY 2018 GDUFA Fees

Fee Type 2017 2018
Facility Fees Domestic Foreign Domestic Foreign
API $44,234 $59,234 $45,367 $60,367
FDF $258,646 $273,646 $211,087 $226,087
CMO N/A N/A $70,362 $85,362
ANDA Program Fees – Based upon the number of approved ANDAs held
Large (20 or more ANDAs) N/A $1,590,792
Medium (6 – 19 ANDAs) N/A $636,317
Small (5 or fewer ANDAs) N/A $159,079
Application Fees
ANDA $70,480 $171,823
Type II DMF $51,140 $47,829

Not sure which user fees you may be subject to? Registrar Corp’s Regulatory Specialists can help determine your relevant fees and facilitate payment with FDA.   Call us at +1-757-224-0177, or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Compliance Date Passed for Consumer Antiseptic Wash Final Rule

September 6th, 2017 marked the compliance date for the U.S. Food and Drug Administration’s (FDA) Consumer Antiseptic Wash Final Rule.  As of this date, over-the-counter (OTC) antiseptic washes containing any of nineteen active ingredients deemed by FDA as not “generally recognized as safe and effective” (GRASE) are not permitted to be introduced into interstate commerce without approval of a new drug application (NDA).  The rule applies to antiseptic washes intended to be used with water and does not cover products such as wipes or hand sanitizers.  Soaps, hand washes, and body washes containing these ingredients that are currently in retail establishments do not require removal, but new batches of these products may not enter the market.  You will find the list of affected ingredients below.

Why are these ingredients not GRASE?

Before the September 6 compliance date, products containing the nineteen affected ingredients were able to be marketed without approval of an NDA.  The ingredients were part of a 1994 tentative final monograph for OTC antiseptic drug products.

In 2013, FDA published a proposed rule to amend the 1994 monograph.  The Agency stated that further review of the data revealed the monograph did not sufficiently account for the health risks associated with repeated, long-term exposure to these ingredients and risks were greater than previously thought.  According to FDA, long-term exposure can have hormonal effects and can lead to the development of bacterial resistance.  In terms of effectiveness, FDA determined there was insufficient evidence that using products containing the covered ingredients was more beneficial than using products used for a comparable purpose with lower health risk (i.e. non-antibacterial soap and water).  Due to these findings, FDA deemed these nineteen ingredients “not generally recognized as safe and effective” for this intended use.

FDA has not yet made a determination on three additional active ingredients: benzalkonium chloride, benzethonium chloride, and chloroxylenol.  In March of 2017, FDA granted an additional year for interested parties to conduct studies providing further data that would support the safety and effectiveness of these ingredients.  Products using these ingredients may currently be introduced into the market, and FDA states that it may extend this time period if studies yield adequate progress.

Not sure how this rule affects your products?  Registrar Corp’s Regulatory Specialists can help determine how FDA regulates your specific antiseptic wash products and review your labeling for compliance.  For questions or assistance, call us at +1-757-224-0177. Alternatively you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Ingredients Deemed Not Generally Recognized as Safe and Effective under the Consumer Antiseptic Wash Final Rule:

Cloflucarban
Methylbenzethonium chloride
Fluorosalan
Phenol (greater than 1.5 percent)
Hexachlorophene
Phenol (less than 1.5 percent)
Hexylresorcinol
Secondary amyltricresols
Iodophors (Iodine containing ingredients)
• Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
• Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
• Nonylphenoxypoly (ethyleneoxy) ethanoliodine
• Poloxamer—iodine complex
• Povidone-iodine 5 to 10 percent
• Undecoylium chloride iodine complex
Sodium oxychlorosene
Tribromsalan
Triclocarban
Triclosan
Triple dye

 

‘Natural,’ ‘Healthy,’ ‘Gluten Free’ ‘Organic’ & ‘Non-GMO’ Claim Requirements

More consumers are joining the clean label movement and turning away from artificial ingredients, preservatives, antibiotics and other man-made food modifiers. According to Nielsen, 48 percent of U.S. consumers choose local, natural and organic products when possible, and a study in the Journal of Food Science found consumers are willing to pay more for foods labeled “all-natural”.

Statistics such as these have many food manufacturers wondering what the rules are for playing this clean label game. Manufacturing giants such as Campbell Soup Company and Mondelez have been simplifying their ingredient lines to eliminate artificial colors, preservatives and flavors to incorporate ingredients recognizable to the average consumer. Capturing this consumer trend has a distinct marketing advantage, and it shows no signs of going away.

Defining Natural

FDA currently has no formal regulatory definition for “natural,” but the agency has long considered the term to mean “nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in that food.” In November 2015, FDA asked for comments on the use of “natural” in human food labeling after receiving three citizen petitions requesting the agency revisit use of the term. Specifically, FDA asked whether it is appropriate to define the term “natural,” how it should define “natural,” and how it should determine appropriate use of the term on food labels. The comment period closed in May 2016, leaving FDA more than 7,000 comments to comb through. Until FDA comes back with a formal definition, it’s best to go by the agency’s definition.

Defining Healthy

To label most foods as “healthy”, current FDA regulations require that specified amounts of the product:

  • Contain at least 10 percent of the daily value for vitamins A, C, calcium, iron, protein or fiber;
  • Meet FDA requirements for a “low fat” and “low saturated fat” claim, and;
  • Meet cutoff requirements for sodium and cholesterol.

Due to evolving public health recommendations and industry criticism of these current criteria, FDA published a request for information to solicit public input on redefining the term “healthy” in September 2016.

One case that led to re-evaluation of the term involved KIND LLC, which was issued a warning letter in March 2015 after FDA reviewed some of KIND’s food labels and found that, among other things, some of the products were too high in saturated fat to claim they were healthy. In response, KIND submitted a citizen petition to FDA in December 2015, urging the agency to update its definition of “healthy” to reflect modern dietary guidance. For example, FDA’s current definition of “healthy” rules out foods like nuts, avocados, salmon and eggs. While high in fats, these foods are generally recognized as part of a healthy diet. The current definition of “healthy” also factors in vitamins A and C, which have been made voluntary under the new Nutrition Facts labeling rules, but omits potassium and vitamin D, which are now mandatory.

So far, nearly 900 comments have been submitted in response to FDA’s request for information, and the agency will continue accepting comments through April 26, 2017. Until FDA finalizes a new definition for “healthy,” manufacturers should continue to use the current regulatory definition. FDA is also using enforcement discretion to allow a food to be labeled as “healthy” if it:

  • Does not meet the requirement for “low fat,” provided the sum of the mono and polyunsaturated fats is greater than the total amount of saturated fat and that these amounts are declared on the label, or;
  • Contains at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

Gluten-Free

FDA issued a final rule for labeling food “gluten-free” in August 2013. In addition to “gluten-free,” the agency’s definition applies to food labeled with the terms “free of gluten,” “no gluten” and “without gluten”.

Before the rule came into effect, there was no federal standard for using these terms. This posed a danger for consumers with the digestive disorder celiac disease, for whom consuming gluten can cause negative health effects.

Under FDA’s rule, a food may be labeled as “gluten-free” so long as it does not contain an ingredient that:

  • Is any type of wheat, rye, barley, or crossbreeds of these grains.
  • Is derived from these grains and has not been processed to remove gluten.
  • Contains 20 or more parts per million (ppm) gluten.

This includes products that are inherently gluten free (like rice) as well as those that have been specifically processed or formulated to remove gluten.

Organic

USDA regulates the term “organic” on food labeling, even for foods under FDA jurisdiction. There are four ways that foods may be labeled as organic:

  • Products made with 100 percent organic ingredients may use the USDA Organic Seal or the term “100 percent organic.”
  • Products made with at least 95 percent organic ingredients may use the USDA Organic Seal or the term “organic”.
  • Products made with 70 to 95 percent organic ingredients may use the phrase “made with organic _____________.”
  • Products made with less than 70 percent organic ingredients may only disclose individual organic ingredients in the ingredient statement.

Water and salt should not be considered when calculating the percentage of organic ingredients in a food product.

USDA’s regulations for labeling food as organic are strict and extensive. For example, the agency will not consider an ingredient to be organic if it is produced with genetic engineering, ionizing radiation or sewage sludge, or if it contains sulfites, nitrates, or nitrites added during the production or handling process. Also, most foods labeled as organic must be overseen by a USDA National Organic Program-authorized certifying agent. Manufacturers should familiarize themselves with all of USDA’s requirements before labeling food with the term “organic.”

Non-GMO

A significant trend within the food industry over the last decade has been the labeling of products as not containing bioengineered ingredients (also known as genetically modified organisms or GMOs). Currently, there is no federal regulation pertaining to the labeling of food as GMO or non-GMO, but this is soon to change. In July 2016, then-President Barack Obama signed a bill into law that requires USDA to develop a mandatory disclosure standard for bioengineered foods. The law gives USDA two years (until July 2018) to determine the standard and establish the regulations to enforce it. The regulations must specify how much of a GMO substance a product may contain before needing to disclose and the way the product must be labeled. The law directs USDA to allow manufacturers to disclose GMO ingredients via text, a symbol or a link. The law applies not only to USDA-regulated products, but those under FDA jurisdiction as well. This statute overrides any state laws that were in place or in progress.

Food manufacturers wishing to ride the wave of the clean label movement should take care to ensure claims made about their products are appropriate. Even in the absence of a regulation, FDA issues warning letters to companies that they deem are making false and misleading statements regarding claims such as “natural” and enforces those for claims such as “gluten-free.” Proper declaration of such claims can help manufacturers maximize sales of their products while also keeping them off FDA’s radar.

This post was originally published on Natural Products Insider.

Compliance Date Approaching for FSMA Preventive Controls Rules

September 18, 2017 marks the next compliance date under the Preventive Controls for Human and Animal Food Rules of the 2011 Food Safety Modernization Act (FSMA).  The U.S. Food and Drug Administration (FDA) will require larger animal food businesses and smaller human food businesses with fewer than 500 full-time employees to begin complying with preventive controls requirements that include the development and implementation of written Food Safety Plans.  Small animal food businesses with fewer than 500 full-time employees must implement Current Good Manufacturing Practices (CGMP) established by the animal food rule and will be expected to comply with remaining preventive controls requirements next year on September 17, 2018.

Compliance with preventive controls and CGMPs may involve considerable time and effort to achieve.  While FDA has stated that it does not plan to conduct routine inspections on these specific areas immediately, the agency has suggested that it may react in response to a food safety issue or complaint.  In order to ensure your facility is prepared for compliance at all times, Registrar Corp provides important information regarding what will be expected of covered food facilities this September.

What does compliance look like?

For larger animal food and smaller human food businesses:

Food businesses complying with preventive controls will be required to develop and implement written Food Safety Plans that feature an analysis of known or reasonably foreseeable food hazards as well as the measures required to prevent or minimize their threat to public health.  Within this plan, covered food facilities should document appropriate monitoring and verification of their specified preventive controls.  Examples include appropriate controls for Salmonella, appropriate controls for potential mycotoxins and for nutrient deficiencies or toxicities, and evidence that scientifically validates proposed preventive measures.

As part of this plan, FDA requires any covered food facility that identifies hazards needing preventive controls to develop a written recall plan.  The plan should establish detailed procedures that outline how the buyer of the food and the public will be notified of the recall and hazard in question.  It should also outline the steps that will be taken to verify that the recall is being enacted and the method that will be used to properly dispose of the recalled food.

Food Safety Plans can be complicated, and FDA requires a “Preventive Control Qualified Individual,” defined by FDA as an individual with appropriate training or job experience to effectively carry out the requirements under these regulations, to develop them.  Registrar Corp’s Regulatory Specialists possess the requisite qualifications to develop a Food Safety Plan for your facility.

For smaller animal food businesses:

Animal food facilities within this category will be required to implement and maintain CGMP standards outlined by FDA.  These standards focus upon fundamental food safety practices in regard to the manufacture of animal food.  Facilities will be required to ensure that daily operations limit possible food contamination from a variety of factors.

Staff in direct contact with food or food-contact surfaces should follow hygienic practices such as consistently washing hands and removing jewelry that could fall into batches of food.  Facility grounds should be properly maintained and free from litter and waste to exclude pests.  Additionally, the construction and layout of facilities should allow for proper cleaning, maintenance, and pest control, while taking measures to prevent potential contamination of food from factors such as condensation dripping off of pipes or fumes that need proper ventilation.

Not sure if your facility is properly following CGMP requirements?  Registrar Corp’s Food Safety Specialists can perform a Mock FDA inspection that identifies potential food safety violations and educates facility staff on FDA expectations.  Mock Inspections are included in Registrar Corp’s U.S. Agent service at no charge, aside from travel and lodging costs.

Registrar Corp assists companies with FDA compliance.  Our Regulatory Specialists are knowledgeable and experienced in the various aspects of FSMA and can help your food facility take the necessary steps to meet FDA’s extensive food safety requirements.  For more information, please call +1-757-224-0177.  Alternatively, you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

FDA Has Started Inspecting U.S. Importers for FSVP Compliance

As of May 30, 2017, most U.S. importers of food and beverages for human and animal consumption are required to comply with the U.S. Food and Drug Administration’s (FDA) Foreign Supplier Verification Program (FSVP) rule.  Since the compliance deadline, Registrar Corp is aware that importers have begun receiving emails from FDA with the subject line: “FSVP Inspection Requirements, Handouts & Law.” This email informs importers of an upcoming FDA inspection to examine their compliance with FSVP requirements.  In light of these recent events, Registrar Corp provides importers with pertinent information to be prepared for a possible FSVP inspection.

What is a FSVP?

The FSVP rule requires U.S. importers of food and beverages to designate a “Qualified Individual,” defined by FDA as possessing either appropriate training or job experience reflecting the ability to develop a food safety system, to develop FSVPs for each food from each foreign supplier.  This means that multiple foods from a single supplier or multiple units of a single food from multiple suppliers each require individual FSVPs.  FSVPs require several components including hazard analysis, an evaluation of risk and supplier performance, documented supplier verification activities, and a plan for corrective actions should a supplier be found non-compliant.

In a single FSVP, a hazard analysis of the food item should be conducted, identifying any potential and foreseeable biological, chemical, or physical hazards that could cause illness or injury in the absence of preventive measures.  The importer should assess the probability and severity of the illness or injury should these measures not be implemented, while considering a diverse array of variables, such as manufacturing procedures, raw materials and ingredients, and the transportation, storage, and distribution of the food.

An evaluation of risk and supplier performance should consider the results of the hazard analysis while assessing the supplier’s food safety practices and procedures, its compliance with U.S. food safety regulations, as well as its history of correcting food safety problems to determine the level of health risk when importing from the supplier.  Importers should determine appropriate verification measures relative to the level of food safety risk the supplier poses.  Verification activities may include onsite audits, sampling, and/or review of the supplier’s food safety records.

Provided any food safety issues arise, an importer is required by FDA to take the proper steps toward correcting the issue with the supplier.  Corrective Actions may vary depending upon specific issues, and in severe cases, may require the importer ceasing business with the supplier until they are found compliant.  One such issue may be that a supplier is lacking a Food Safety Plan as required under the FSMA Preventive Controls rule.  Registrar Corp is experienced in the development of these plans and can assist the supplier in becoming compliant so both parties may continue business.

What Does a FSVP Inspection Look Like?

According to an interview with Sharon Mayl at FDA, FSVP inspections are not to be confused with traditional food facility inspections and consist of a document review. This review may examine whether an importer has detailed components required under the FSVP rule for the specified suppliers and food items.  The inspector may also look for evidence that FSVP procedures are followed between importer and supplier for the food items in question and that the importer is documenting appropriate analyses and verification activities, reviewed by a Qualified Individual.

Registrar Corp’s Regulatory Specialists can assist in developing appropriate FSVPs for your food items.  Additionally, Registrar Corp’s FDA Compliance Monitor can monitor suppliers’ compliance history as required under the rule and can serve as proof of compliance during a FDA FSVP inspection.

Registrar Corp assists food and beverage companies with FDA compliance.  For more information or assistance with specific FSVP requirements, please call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

U.S. FDA Announces Reinspection Fees Fiscal Year 2018

The U.S. Food and Drug Administration (FDA) recently published the hourly rates for the reinspection of food facilities during fiscal year (FY) 2018.  The cost of reinspection for a domestic facility is $248 per hour, a $27 increase from FY 2017.  The cost for a foreign facility is $285 per hour, the same as in FY 2017.

The total cost of a reinspection depends upon the amount of time FDA performs inspection-related duties.  This may involve preparation for the inspection, travel to and from the facility being inspected, the physical examination of the premises, and any sample analysis or lab work required.  Reinspection fees can quickly add up to thousands of dollars, especially for facilities in countries where travel alone can take a day’s time. To avoid these potentially high reinspection fees, it is prudent to take measures to ensure that proper food safety procedures are in place when FDA inspects a food facility the first time.

What is a reinspection?

When a food facility registers with FDA, it grants FDA permission to inspect the facility at any given time. Initial FDA food facility inspections are of no cost to the facility and may occur due to routine reasons, a facility’s level of potential risk to public health, or as a response to a problem or complaint.

If FDA discovers certain food safety violations during an initial inspection, the Agency may decide it needs to return at a later date to evaluate whether the facility implemented appropriate corrective actions.  This second evaluation is considered a reinspection (also sometimes referred to as a “compliance follow-up inspection”).

The frequency at which initial FDA inspections occur may continue to increase in response to mandates under the 2011 Food Safety Modernization Act (FSMA).  FSMA directs FDA to inspect domestic facilities at a rate determined by the risk its products pose to public health.  High-risk facilities are to be inspected every three years, while low-risk facilities are to be inspected every five years.  FSMA also directed FDA to increase its annual inspection of foreign facilities. FDA provides foreign facilities with notice that an inspection of the facility will occur.  Domestic facilities may receive no notice at all.  Regardless, it is crucial for all facilities to take steps to be prepared for the initial FDA inspection at all times.

What factors could warrant a reinspection?

FDA’s most recently published data on commonly occurring inspection violations at food facilities indicates food safety issues that FDA may likely search for while inspecting a facility. The most frequent violations in FY2016 included:

  • Lack of Effective Pest Exclusion / Screening – FDA cites a facility for not taking effective preventative measures against pest presence in food processing areas or not implementing controls to protect food from contamination due to pests.
  • Sanitation Monitoring – FDA cites a facility for failing to effectively monitor sanitation practices and conditions consistently.
  • Floors, Walls, and Ceilings – FDA cites a facility for being constructed in a way that inhibits proper sanitation and repair of the floors, walls, and ceilings.
  • Importer Verification – FDA cites a seafood importer for failing to document verification of a supplier’s compliance with Seafood Hazard Analysis and Critical Control Points (HACCP) Regulations.
  • HACCP Plan Implementation – FDA cites a facility for failing to implement procedures established in its written HACCP Plan. It is important to note that following the compliance date in September 2016, FDA is now likely to also check for proper implementation of Hazard Analysis and Risk-based Preventative Control (HARPC) Plans at most food facilities.

Several violations in the above list were just as frequent in 2015 as they were in 2016.  Registrar Corp urges food facilities to examine these issues and take the appropriate measures to prevent FDA citations for these and similar food safety problems.

Proper preparation for an initial inspection may reduce the chance of FDA citing a facility for violations that can cause return visits. Having a third party trained in FDA inspections review your facility for violations is often an invaluable business decision. Poor results from an initial inspection not only can result in an expensive reinspection, but also in Warning Letters and other public information that could damage a brand’s reputation. While there may be costs associated with third-party assistance, it is likely more affordable than the alternative.

Registrar Corp offers a Mock FDA Inspection service in which our Food Safety Specialists identify potential food safety problems and educate staff on FDA expectations.  This Mock FDA Inspection service is included as part of Registrar Corp’s U.S. Agent service at no charge, aside from lodging and travel expenses.

For questions or assistance with FDA compliance, call Registrar Corp at +1-757-224-0177.  Additionally, you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Australia Receives Systems Recognition with U.S. FDA

As of April 2017, the U.S. Food and Drug Administration (FDA) officially recognizes the Australian Department of Agriculture and Water Resources as having a comparable Food Safety System, granting it systems recognition.  Australia is the third country to make this arrangement with FDA—the first being New Zealand in 2012, and the second being Canada in 2016.

This recognition allows importation of Australian-produced foods into the United States without the extensive requirements imposed by FSMA’s Foreign Supplier Verification Program.  Instead of conducting detailed hazard analyses and verification activities as is required from food from other countries, U.S. importers now may simply verify that the producing firm is in good standing with the Australian Department for that type of product.

What is Systems Recognition?

Systems recognition is an arrangement where FDA agrees upon a similarity between its own Food Safety System and that of another country seeking this arrangement, where both provide similar protection and monitoring of food products. The concept is based upon the idea that Food Safety Systems adhering to similar standards will produce similar outcomes—ideally the production of safe food.

What are the Benefits of Being Recognized by FDA?

FDA’s Food Safety Modernization Act (FSMA) introduced extensive new food safety regulations for both food facilities and U.S. importers of food products. While still subject to FSMA, food facilities in recognized countries and domestic importers of food manufactured in recognized countries benefit from modified requirements.  As more faith is granted to the Food Safety Systems of recognized countries, these parties may see less FDA intervention as a result.

Under FSMA, food facilities that manufacture, process, pack, or hold food for U.S. consumption are required by FDA to have written food safety plans.  One component of this plan is a supply-chain program that mandates facilities to conduct verification activities on their suppliers, such as onsite audits.  As opposed to conducting these audits themselves, facilities with suppliers in recognized countries are able to verify suppliers through an inspection conducted by that country’s food safety authority within one year of the required audit date, potentially saving resources on travel and personal expenses.

FSMA also requires U.S. importers to create a Foreign Supplier Verification Program (FSVP) for each of their foreign suppliers, involving hazard analysis, risk evaluation, supplier verification, and corrective action.  Systems recognition allows importers to forgo certain aspects of the FSVP rule, such as hazard analysis and verification, as long as they continue to monitor and find that each supplier is compliant with its country’s Food Safety System.  As a result, importers are able to save time and effort as well as travel expenses when importing food from recognized countries. This may provide facilities in recognized countries an advantage over competition, as US importers may be more apt to import from facilities that require less work under FSVP.

Use Registrar Corp’s free FSMA Wizard for information on how FSMA rules affect your specific country and facility.

How Does a Country Become Recognized?

In order to meet systems recognition, a country’s governmental Food Safety System must undergo a review of its compliance history by FDA. The Agency will examine data on past refusals of admission, import alerts from products originating in that country, and other areas of concern.  Following this review, the interested country will hold a consultation with FDA to outline its goals for achieving systems recognition and the steps that need to be taken to move forward in this process.

If the country is still interested in becoming recognized after the consultation, its regulatory agency or authority must complete the International Comparability Assessment Tool (ICAT) to determine whether or not its Food Safety System meets ten standards outlined by FDA.  Upon its completion, FDA will review the ICAT along with the data collected during the initial review.  If deemed that the interested country satisfies these standards, FDA will take the steps toward arranging an in-country assessment of the country’s system to attempt to finalize the systems recognition process.

Can I Still Export To The US If My Country Is Not Recognized?

While there are benefits to being recognized, systems recognition is entirely voluntary and is not required to export food to the United States.  A company interested in exporting food to the U.S. must still complete all of the steps necessary for complying with FDA regulations.

If you represent a company looking to export or import food to the United States, Registrar Corp can assist in complying with FDA’s requirements promptly and correctly.  For more information on FDA requirements or Registrar Corp’s services, please call +1-757-224-0177.  Additionally, 24-hour live chat assistance is available at www.registrarcorp.com/livehelp.

 

FDA Exempts Certain Class II Devices from Premarket Notification (510(k))

On July 10, 2017, the U.S. Food and Drug Administration (FDA) announced it is exempting or partially exempting certain class II devices from premarket notification (510(k)) requirements. According to FDA, the newly exempt devices “are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness.” You’ll find the list of affected devices below.

What is a partially exempt device?

Certain devices are only exempt from 510(k) under the Federal Register if they meet criteria specified by FDA.  FDA created new product codes for listed devices that fit these criteria.  Listed devices that do not meet the criteria will continue to use the pre-existing product code. The criteria are included in the list of partially exempt devices below. The majority of FDA’s partial exemptions are for products intended for employment and insurance testing.

What does this mean for medical device companies?

The new exemptions may prove to be a relief of regulatory burden that allows manufactures of affected devices to move forward with business in the United States.  510(k) requirements are often prohibitive for manufacturers; the regulations are extensive and the testing and research required can be expensive.

Manufacturers of devices subject to 510(k) requirements must prove to FDA that the devices are “substantially equivalent” to similar legally marked devices.   510(k) submissions must contain information such as proposed labeling and advertisements, a summary of the technological characteristics of the device, discussion of submitted tests, and much more.  There is no 510(k) form or template, but all information must be formatted as described in 21 CFR 807.

Manufacturers of 510(k) exempt devices are still subject to other FDA requirements for medical devices, such as annual registration and listing, UDI requirements, adverse event reporting, labeling requirements, and complying with good manufacturing practices.  Registrar Corp can assist manufacturers of newly exempt products to comply with FDA’s other regulations.

For questions or assistance with FDA regulations for medical devices, contact Registrar Corp at +1-757-224-0177, or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Exempt Devices

21 CFR Section Device Type Product Code
862.1020 Acid Phosphatase, Nitrophenylphosphate CJN
862.1020 Acid Phosphatase, Thymol Blue Monophosphate CJR
862.1020 Acid Phosphatase, Disodium Phenylphosphate CJX
862.1020 Acid Phosphatase, Naphthyl Phosphate CKB
862.1020 Acid Phosphatase, Thymolphthale Inmonophosphate CKE
862.1020 Acid Phosphatase, Beta Glycerophosphate CKH
862.1020 Acid Phosphatase (Prostatic), Tartrate Inhibited JFH
862.1090 Radioassay, Angiotensin Converting Enzyme KQN
862.1100 Vanillin Pyruvate, AST/SGOT CIF
862.1100 Diazo, AST/SGOT CIQ
862.1100 Hydrazone Colorimetry, AST/SGOT CIS
862.1100 NADH Oxidation/NAD Reduction, AST/SGOT CIT
862.1150 Calibrator, Primary JIS
862.1150 Calibrator, Secondary JIT
862.1150 Calibrator, Surrogate JIW
862.1150 Calibrator, Multi-Analyte Mixture JIX
862.1345 Drink, Glucose Tolerance MRV
862.1350 Continuous Glucose Monitor Secondary Display PJT
862.1445 Chromatographic Separation, Lactate Dehydrogenase Isoenzymes CEX
862.1445 Electrophoretic, Lactate Dehydrogenase Isoenzymes CFE
862.1445 Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes JGF
862.1509 System, Test, Urinary Methylmalonic Acid LPT
862.1685 Radioimmunoassay, Thyroxine-Binding Globulin CEE
862.1700 Radioimmunoassay, Total Thyroxine CDX
862.1700 Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine KLI
862.2265 High Throughput DNA Sequence Analyzer PFF
862.2570 Instrumentation For Clinical Multiplex Test Systems NSU
862.2570 Real Time Nucleic Acid Amplification System OOI
862.2570 Mass Spectrometer For Clinical Multiplex Test Systems OTA
862.2570 Micro Total Analysis Instrument System OUE
862.2570 Complete Gene Expression Profiling Accessory Reagents OVA
862.2570 DNA Genetic Analyzer PCA
862.2570 Data Acquisition Software PQQ
862.3200 Calibrators, Drug Mixture DKB
862.3200 Calibrators, Drug Specific DLJ
862.3200 Calibrators, Ethyl Alcohol DNN
864.5400 Fibrometer GIE
864.5400 Timer, Coagulation JBT
864.5425 Control, Plasma, Abnormal GGC
864.5425 Plasma, Coagulation Control GGN
864.5425 Plasma, Control, Normal GIZ
864.6550 Control, Fecal Occult Blood OSL
864.6550 Study, Platelet Adhesive JBZ
864.7275 Test, Euglobulin Lysis JBO
864.7300 Fibrin Monomer Paracoagulation JBN
864.7340 Fibrinogen Standard GFX
864.7340 Plasma, Fibrinogen Control GIL
864.7375 Glutathione, Red-Cell GII
864.7375 Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase JMH
864.7375 Assay, Glutathione Reductase KQF
864.7415 Control, Hemoglobin, Abnormal JCM
864.7455 Stain, Fetal Hemoglobin GHQ
864.7500 Acid Hematin GGF
864.7720 Test, Prothrombin Consumption GGQ
864.7735 Prothrombin-Proconvertin and Thrombotest JPF
864.8150 Calibrator for Cell Indices KRX
864.8165 Calibrator for Hemoglobin and Hematocrit Measurement KRZ
864.8175 Calibrator for Platelet Counting KRY
864.8185 Calibrator for Red-Cell and White-Cell Counting KSA
864.8625 Standards and Controls, Hemoglobin, Normal and Abnormal GFS
864.8625 Control, White-Cell GGL
864.8625 Control, Hemoglobin GGM
864.8625 Control, Platelet GJP
864.8625 Control, Red-Cell GJR
864.8625 Control, Hematocrit GLK
864.8625 Mixture, Control, White-Cell and Red-Cell Indices GLQ
864.8625 Control, Cell Counter, Normal and Abnormal JCN
864.8625 Mixture, Hematology Quality Control JPK
864.8625 Material, Quality Control, Semen Analysis NRF
864.8625 Control Material, Blood Circulating Epithelial Cancer Cell NRS
864.9400 Solution, Stabilized Enzyme KSK
866.3395 Norovirus Serological Reagents OUC
866.5210 Immunochemical, Ceruloplasmin CHN
866.5210 Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control DCT
866.5210 Ceruloplasmin, FITC, Antigen, Antiserum, Control DCY
866.5210 Ceruloplasmin, Antigen, Antiserum, Control DDB
866.5210 P-Phenyl-Enediamine/EDTA (Spectrophotometric), Ceruloplasmin JFQ
866.5210 Indirect Copper Assay, Ceruloplasmin JFR
866.5470 Hemoglobin, Chain Specific, Antigen, Antiserum, Control DAM
866.5620 Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control DDT
866.5620 Alpha-2-Macroglobulin, FITC, Antigen, Antiserum, Control DDY
866.5620 Alpha-2-Macroglobulin, Antigen, Antiserum, Contro DEB
866.5630 System, Test, Beta-2-Microglobulin Immunological JZG
866.5910 Quality Control Material, Genetics, DNA NZB
868.1040 Algesimeter, Powered BSI
868.1400 Legging, Compression, Non-Inflatable LLK
868.2500 Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK
868.2500 Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia LPP
868.2550 Pneumotachometer JAX
868.5180 Bed, Rocking, Breathing Assist CCO
868.6250 Compressor, Air, Portable BTI
870.1390 Trocar DRC
870.1875 Lung Sound Monitor OCR
870.2675 Oscillometer DRZ
870.4280 Filter, Prebypass, Cardiopulmonary Bypass KRJ
870.4290 Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
870.4340 Monitor and/or Control, Level Sensing, Cardiopulmonary Bypass DTW
870.4420 Sucker, Cardiotomy Return, Cardiopulmonary Bypass DTS
870.4430 Suction Control, Intracardiac, Cardiopulmonary Bypass DWD
872.1720 Tester, Pulp EAT
872.3260 External Cleaning Solution PME
872.3300 Coating, Denture Hydrophilic, Resin EBE
872.3540 Pad, Denture, Over The Counter EHR
872.3540 Cushion, Denture, Over The Counter EHS
872.3560 Reliner, Denture, Over The Counter EBP
872.3590 Denture, Plastic, Tooth ELM
872.3600 Denture Preformed (Partially Prefabricated Denture) EKO
872.3890 Splint, Endodontic Stabilizing ELS
872.5550 Ring, Teething, Fluid-Filled KKO
872.6770 Syringe, Cartridge EJI
874.1120 Generator, Electronic Noise (for Audiometric Testing) ETS
874.1325 Electroglottograph KLX
874.3310 Calibrator, Hearing Aid/Earphone and Analysis Systems ETW
874.3320 Hearing Aid, Group and Auditory Trainer EPF
874.3320 Device, Assistive Listening LZI
874.3330 Hearing Aid, Master KHL
874.3430 Mold, Middle-Ear ETC
874.3730 Device, Voice Amplification MCK
876.1500 Light Source, Incandescent, Diagnostic FCQ
876.1500 Light Source, Photographic, Fiberoptic FCR
876.1500 Light Source, Fiberoptic, Routine FCW
876.1500 Carrier, Sponge, Endoscopic FGS
876.1500 Light Source, Endoscope, Xenon Arc GCT
876.1500 Transformer, Endoscope GCW
876.1500 LED Light Source NTN
876.1500 Endoscopic Guide Wire, Gastroenterology-Urology OCY
876.4020 Light, Catheter, Fiberoptic, Glass, Ureteral FCS
876.4270 Rod, Colostomy EZP
876.4400 Ligator, Hemorrhoidal FHN
876.4400 Ligator, Esophageal MND
876.4500 Lithotriptor, Biliary Mechanical LQC
876.4770 Urethrotome EZO
876.5010 Bag, Bile Collecting EXF
876.5025 Vibrator for Climax Control of Premature Ejaculation PIA
876.5365 Dilator, Esophageal (Metal Olive) Gastro-Urology EZM
876.5365 Bougie, Esophageal, and Gastrointestinal, Gastro-Urology FAT
876.5365 Dilator, Esophageal KNQ
876.5520 Dilator, Urethral KOE
876.5665 Disinfectant, Subsystem, Water Purification NIH
876.5820 Set, Dialyzer Holder FKI
876.5895 Irrigator, Ostomy EXD
876.5980 Catheter, Retention, Barium Enema With Bag FGD
876.5980 Gastrostomy Tube Holder PLI
878.4370 Drape, Surgical, ENT ERY
878.4370 Drape, Pure Latex Sheet, With Self-Retaining Finger Cot EYX
878.4370 Drape, Urological, Disposable EYY
878.4370 Pad, Kelly FNW
878.4370 Drape, Patient, Ophthalmic HMT
878.4370 Drape, Microscope, Ophthalmic HMW
878.4370 Ring (Wound Protector), Drape Retention, Internal KGW
878.4580 Lamp, Operating-Room FQP
878.4580 Light, Surgical, Instrument FSQ
878.4580 Light, Surgical, Floor Standing FSS
878.4580 Light, Surgical, Endoscopic FSW
878.4580 Light, Surgical, Connector FSX
878.4580 Light, Surgical, Ceiling Mounted FSY
878.4580 Light, Surgical, Carrier FSZ
878.4580 Light, Surgical, Accessories FTA
878.4580 Lamp, Surgical FTD
878.4580 Illuminator, Remote FTG
878.4580 Lamp, Surgical, Incandescent GBC
878.5070 Apparatus, Air Handling, Bench FZG
878.5070 Apparatus, Air Handling, Room FZH
878.5070 Apparatus, Air Handling, Enclosure FZI
880.5580 Locator, Acupuncture Point BWJ
880.5580 Needle, Acupuncture, Single Use MQX
880.5780 Stocking, Medical Support (to Prevent Pooling of Blood in Legs) DWL
882.1020 Analyzer, Rigidity GZM
882.1540 Device, Galvanic Skin Response Measurement GZO
882.1560 Device, Skin Potential Measurement HCJ
882.1855 Encephalogram Telemetry System GYE
882.5895 Vibratory Counter-Stimulation OVP
884.2990 Sheet, Recording, Breast Examination NHM
884.3200 Drain, Cervical HFL
884.4400 Forceps, Obstetrical HDA
884.4530 Clamp, Umbilical HFW
884.4530 Speculum, Vaginal, Nonmetal HIB
884.4530 Speculum, Vaginal, Nonmetal, Fiberoptic HIC
884.4530 Clamp and Cutter, Umbilical NBZ
884.4900 Table, Obstetrical, AC-Powered (and Accessories) HDD
884.4900 Table, Obstetrical, Manual (and Accessories) HHP
884.4900 Table, Obstetric (and Accessories) KNC
884.5200 Hemorrhoid Prevention Pressure Wedge OOA
884.5390 Heater, Perineal, Direct Contact HGZ
884.5390 Heater, Perineal, Radiant, Non-Contact HHA
884.5390 Heater, Perineal KND
884.5400 Cup, Menstrual HHE
884.5425 Pad, Menstrual, Scented HHL
884.6150 Micromanipulators and Microinjectors, Assisted Reproduction MQJ
886.1120 Photorefractor MMF
886.1120 Camera, Ophthalmic, General-Use PJZ
886.1250 Euthyscope, AC-Powered HMK
886.1570 Ophthalmoscope, AC-Powered HLI
886.1570 Ophthalmoscope, Battery-Powered HLJ
886.1570 Ophthalmoscopes, Replacement Batteries, Hand-Held MSG
886.1780 Retinoscope, AC-Powered HKL
886.1945 Transilluminator, AC-Powered HJM
886.4150 Tubing, Replacement, Phacofragmentation Unit MSR
886.4250 Unit, Electrolysis, AC-Powered, Ophthalmic HRO
886.4335 Headlight, Fiberoptic Focusing FCT
886.4335 Light, Headband, Surgical FSR
886.4335 Headlamp, Operating, AC-Powered HPQ
886.4400 Locator, Metal, Electronic HPM
886.4440 Magnet, AC-Powered HPO
886.4790 Sponge, Ophthalmic HOZ
886.4790 Eye Tray OJK
888.1240 Dynamometer, AC-Powered LBB
888.4580 Instrument, Surgical, Sonic and Accessory/Attachment JDX
888.4580 System, Cement Removal Extraction LZV
890.1450 Hammer, Reflex, Powered IKO
890.5100 Bath, Hydro-Massage ILJ
890.5100 Bath, Sitz, Powered ILM
890.5110 Bath, Paraffin IMC
890.5250 Cabinet, Moist Steam IMB
890.5360 Exerciser, Measuring ISD
890.5500 Lamp, Infrared, Therapeutic Heating ILY
890.5575 Device, Warning, Overload, External Limb, Powered IRN
892.1000 MRI Disposable Kit OIM
892.1560 Biopsy Needle Guide Kit OIJ
892.1610 Aperature, Radiographic IZS
892.1610 Cone, Radiographic IZT
892.1610 Collimator, Automatic, Radiographic IZW
892.1610 Collimator, Manual, Radiographic IZX
892.1610 Device, Beam Limiting, X-Ray, Diagnostic KPW
892.1650 Arthrogram Tray OII
892.1650 Radiology Dental Tray OIK
892.1670 Device, Spot-Film IXL
892.1680 Radiographic Contrast Tray OIO
892.1680 Radiology Diagnostic Kit OIP
892.1730 Discography Kit OIL
892.1820 Chair, Pneumocephalographic HBK
892.1850 Cassette, Radiographic Film IXA
892.1860 Changer, Radiographic Film/Cassette KPX
892.1870 Programmer, Changer, Film/Cassette, Radiographic IZP
892.1900 Controller, Temperature, Radiographic EGT
892.1900 Dryer, Film, Radiographic EGW
892.1900 Processor, Radiographic-Film, Automatic, Dental EGY
892.1900 Processor, Radiographic-Film, Automatic IXW
892.1900 Processor, Cine Film IXX
892.2030 Digitizer, Image, Radiological LMA
892.2030 Digitizer, Images, Ophthalmic NFH
892.2040 Camera, Multi Format, Radiological LMC
892.2040 Device, Hardcopy, Images, Ophthalmic NFI
892.5730 Prostate Seeding Kit OIN

Partially Exempt Devices

21 CFR Section Device Type Exempt Product Code Former Product Code (NonExempt) Partial Exemption Limitation
862.3100 Enzyme Immunoassay, Amphetamine PUX DKZ Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3100 Radioimmunoassay, Amphetamine PUX DJP Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3100 Thin Layer Chromatography, Amphetamine PUX DIT Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3100 Gas Chromatography, Amphetamine PUX DOD Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3100 Liquid Chromatography, Amphetamine PUX DNI Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3100 Free Radical Assay, Amphetamine PUX DJL Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150 Enzyme Immunoassay, Barbiturate PUY DIS Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150 Radioimmunoassay, Barbiturate PUY DKN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150 Thin Layer Chromatography, Barbiturate PUY DKX Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150 Mercury Dithiazone, Colorimetry, Barbiturate PUY DJN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150 Hemagglutination Inhibition, Barbiturate PUY DLX Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150 Gas Liquid Chromatography, Barbiturate PUY DMF Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150 High Pressure Liquid Chromatography, Barbiturate PUY KZY Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3170 Enzyme Immunoassay, Benzodiazepine PUZ JXM Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3170 High Pressure Liquid Chromatography, Benzodiazepine PUZ LAA Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3170 Test, Benzodiazepine, Over The Counter PUZ NFV Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3170 Gas Chromatography, Benzodiazepine PUZ KZZ Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3170 Thin Layer Chromatography, Benzodiazepine PUZ LAB Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250 Enzyme Immunoassay, Cocaine and Cocaine Metabolites PVA DIO Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250 Radioimmunoassay, Cocaine Metabolite PVA KLN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250 Enzyme Immunoassay, Cocaine PVA JXO Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250 Hemagglutination, Cocaine Metabolites (Benzoylecgonine) PVA DLN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250 Thin Layer Chromatography, Cocaine PVA DMN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250 Free Radical Assay, Cocaine PVA DIR Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250 Gas Chromatography, Cocaine PVA DIN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250 Thin Layer Chromatography, Benzoylecgonine PVA DOM Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250 High Pressure Liquid Chromatography, Cocaine and Cocaine Metabolites PVA LAC Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3270 High Pressure Liquid Chromatography, Codeine PVB LAE Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3270 Thin Layer Chromatography, Codeine PVB DLD Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3270 Gas Chromatography, Codeine PVB LAD Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3580 Radioimmunoassay, LSD (125-I) PVC DLB Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3580 Free Radical Assay, LSD PVC DOL Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3610 Gas Chromatography, Methamphetamine PVD LAF Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3610 Thin Layer Chromatography, Methamphetamine PVD DJC Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3610 High Pressure Liquid Chromatography, Methamphetamine PVD LAG Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3610 Test, Methamphetamine, Over The Counter PVD NGG Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3620 Enzyme Immunoassay, Methadone PVE DJR Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3620 Hemagglutination Inhibition, Methadone PVE DIW Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3620 Gas Chromatography, Methadone PVE DMB Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3620 Thin Layer Chromatography, Methadone PVE DKR Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3620 Liquid Chromatography, Methadone PVE DNT Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3620 Free Radical Assay, Methadone PVE DPP Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3630 Radioimmunoassay, Methaqualone PVF KXS Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640 Thin Layer Chromatography, Morphine PVG DNK Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640 Radioimmunoassay, Morphine (123-I), Goat Antibody Ammonium Sulfate Sep. PVG DOE Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640 Fluorometry, Morphine PVG DJJ Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640 Liquid Chromatography, Morphine PVG DPK Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640 Gas Chromatography, Morphine PVG DMY Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640 Hemagglutination Inhibition, Morphine PVG DLR Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640 Free Radical Assay, Morphine PVG DOK Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640 Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep. PVG DIQ Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640 Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody PVG DNA Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3650 Enzyme Immunoassay, Opiates PVH DJG Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3650 Gas Chromatography, Opiates PVH DJF Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3650 Hemagglutination, Opiates PVH DLT Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3650 Thin Layer Chromatography, Opiates PVH LAI Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3650 Free Radical Assay, Opiates PVH DKT Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3650 High Pressure Liquid Chromatography, Opiates PVH LAH Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3700 Enzyme Immunoassay, Propoxyphene PVI JXN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3700 Thin Layer Chromatography, Propoxyphene PVI DPN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3700 Gas Chromatography, Propoxyphene PVI LAJ Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3700 High Pressure Liquid Chromatography, Propoxyphene PVI LAK Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3870 Enzyme Immunoassay, Cannabinoids PVJ LDJ Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3870 Reagents, Test, Tetrahydrocannabinol PVJ DKE Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3870 Radioimmunoassay, Cannabinoid(S) PVJ LAT Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3910 High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs PVK LFI Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3910 U.V. Spectrometry, Tricyclic Antidepressant Drugs PVK LFH Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3910 Thin Layer Chromatography, Tricyclic Antidepressant Drugs PVK MLK Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
866.5750 System, Test, Radioallergosorbent (RAST) Immunological PUW DHB Exemption is limited to devices classified under 21 CFR 866.5750 that are intended to detect any of the allergens included in table 3 of this document.
868.2385 Analyzer, Nitrogen Dioxide PUG MRQ Exemption is limited to standalone nitrogen dioxide analyzers and not those that are components of nitric oxide delivery systems intended to monitor nitrogen dioxide levels during inhaled nitric oxide therapy
870.1330 Wire, Guide, Catheter PTL DQX Exemption is limited to accessory torque devices that are manually operated, nonpatient contacting, and intended to manipulate non-cerebral vascular guide wires.
870.1650 Syringe, Balloon Inflation PTM MAV Exemption is limited to non-patient contacting balloon inflation syringes intended only to inflate/deflate balloon catheters and monitor pressure within the balloon.
870.2770 Analyzer, Body Composition PUH MNW Exemption is limited to body composition analyzers which are not intended to diagnose or treat any medical condition.
870.4400 Reservoir, Blood, Cardiopulmonary Bypass PTN DTN Exemption is limited to cardiopulmonary bypass blood reservoirs that do not contain defoamers or blood filters.
874.1090 Tester, Auditory Impedance PTO ETY Exemption is limited to auditory impedance testers that are in compliance with FDArecognized consensus standard ANSI S3.39.
874.1090 Tympanometer PTP NAS Exemption is limited to tympanometers that are in compliance with FDA-recognized consensus standard ANSI S3.39.
876.1500 Endoscopic Magnetic Retriever PTQ FCC Exemption is limited to endoscopic magnetic retrievers intended for single use.
876.1500 Scissors For Cystoscope PTR KGD Exemption is limited to sterile scissors for cystoscope intended for single use.
876.1500 Endoscopic Grasping/Cutting Instrument, NonPowered PTS OCZ Exemption is limited to disposable, nonpowered endoscopic grasping/cutting instruments intended for single use.
876.5010 Catheter, Biliary, Surgica PTT GCA Exemption is limited to surgical biliary catheters that do not include a balloon component.
876.5630 Catheter, Peritoneal, Long-Term Indwelling PTU FJS Exemption is limited to non-patient contacting catheter finger grips intended for single use.
876.5630 Catheter, Peritoneal Dialysis, Single Use PTV FKO Exemption is limited to non-patient contacting catheter finger grips intended for single use.
876.5630 System, Peritoneal, Automatic Delivery PTW FKX Exemption is limited to continuous ambulatory peritoneal dialysis (CAPD) belts and catheter stands that do not include weigh scales.
878.4370 Drape, Surgical PUI KKX Exemption is limited to surgical drapes that do not include an antimicrobial agent.
878.4495 Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile PTX GAQ Exemption is limited to steel monofilament sutures that are uncoated and do not incorporate barbs
882.1470 Computerized Cognitive Assessment Aid PTY PKQ Exemption is limited to computerized cognitive assessment aids that are not intended for diagnostic assessment of specific diseases or conditions and rely on inputs from visual cues, auditory cues, and/or functional use of the hand.
884.1630 Colposcope (and Colpomicroscope) PTZ HEX Exemption is limited to standard colposcopes (and colpomicroscopes) that use only a white light source, do not use filters other than a green filter, do not include image analysis software, and are not smartphone-based.
884.4530 Tenaculum, Uterine PUA HDC Exemption is limited to sterile uterine tenaculum devices that do not use suction and are intended for single use.
884.6120 Accessory, Assisted Reproduction PUB MQG Exemption is limited to simple embryo incubators with temperature, gas, and humidity control only; syringe pumps; collection tube warmers; dish/plate/microscope stage warmers; and controlled-rate cryopreservation freezers.
884.6130 Microtools, Assisted Reproduction (Pipettes) PUC MQH Exemption is limited to assisted reproduction microtools (pipettes) manufactured from glass.
884.6160 Labware, Assisted Reproduction PUD MQK Exemption is limited to dishes and plates that are intended for general assisted reproduction technology procedures.
886.1850 Biomicroscope, SlitLamp, AC-Powered PUE HJO Exemption is limited to slit-lamp, ACpowered biomicroscopes intended only for the visual examination of the anterior segment of the eye, are classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, do not provide any quantitative output, and are not intended for screening or automated diagnostic indications.
886.3320 Ocular Peg PUF MQU Exemption is limited to ocular pegs supplied sterile.




Search Registrar Corp

View Our Locations


Choose Your Language