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2017 in Review – U.S. FDA Medical Device and Drug Regulations

The medical device and drug industries saw numerous regulatory developments in 2017.  The U.S. Food and Drug Administration (FDA) introduced new requirements, fees, deadline extensions, and exemptions.  Below, Registrar Corp provides an overview of regulatory highlights this year.

FDA Removed Medical Device and Drug Establishments that Did Not Register for 2017

Medical device and drug establishments that failed to properly renew their registrations for 2017 were removed from FDA’s active registration database. The Agency will likely do the same in 2018.  Marketing medical devices and drugs without a valid registration is a prohibited act that may be met with seizure and injunction.

FDA Extended the UDI Compliance Date for Class I Devices to 2020

FDA issued a letter in June announcing its intention to extend the universal device identifier (UDI) compliance dates for class I and unclassified devices.  The letter proposes to push the UDI labeling compliance date for these devices to September 24, 2020.

FDA Exempted Certain Class II Devices from 510k

In July, FDA exempted certain class II medical devices from premarket notification (510k) requirements. The 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.”  View a list of the exempt devices here.

The Compliance Date Passed for the Consumer Antiseptic Wash Final Rule

As of September, over-the-counter (OTC) consumer antiseptic washes containing any of nineteen certain ingredients are not permitted to enter interstate commerce without approval of a new drug application (NDA).  FDA made this determination after discovering there was insufficient evidence to support the ingredients’ safety and effectiveness for their intended use.

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

The Medical Device User Fee Amendments (MDUFA) and Generic Drug User Fee Amendments (GDUFA) were reauthorized for fiscal year (FY) 2018.  The amendments introduced differences in rates from FY 2017, as well as new types of fees for certain facilities and submissions.

View the list of fees for medical device establishments here.

View the list of fees for drug establishments here.

FDA Introduced a New Verification Requirement for U.S. Agents of Medical Device Establishments

The U.S. Agent of medical device establishments located outside of the United States is now required to confirm this role with FDA.  Agents must accept their designation through the FDA Unified Registration and Listing System (FURLS).  If the Agent does not respond to a verification email within ten days, the establishment will need to designate a new Agent.

FDA Introduced Annual Certification Requirement for Unchanged Drug Listings

The 2017 registration renewal period introduced a requirement for drug establishments to submit a “blanket no-change” certification for drug listings that did not receive any changes to data or labeling during the year.  Certifications must be submitted in structured product labeling (SPL) format.

FDA Published Final Guidance for UDI Direct Marking Requirements

In November, FDA issued a final guidance to clarify a device labeler’s responsibilities for UDI direct marking requirements.  Class II devices must comply with direct marking requirements by September 24, 2018.  During a December webinar, FDA stated that they do not intend to enforce these requirements for class I and unclassified devices until September 24, 2022.

FDA Issued a Final Rule on the Safety and Effectiveness of Triclosan in Health Care Antiseptics

FDA finalized a rule prohibiting the use of Triclosan and 23 other active ingredients in OTC antiseptics for health care environments.  After December 20, 2018, health care antiseptics containing these ingredients will not be permitted to enter interstate commerce without FDA approval of an NDA.

As we cross into 2018, Registrar Corp will continue to keep the medical device and drug industries informed about important FDA regulations.  For assistance with FDA requirements in either industry, call us at +1-757-224-0177, or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

2017 in Review – U.S. FDA Food and Beverage Regulations

2017 brought a host of changes for food manufacturers and importers.  The U.S. Food and Drug Administration (FDA) had a year of announcements, proposals, and deadlines for the food and beverage industry.  Perhaps most notable were the passing of two compliance dates for rules under the Food Safety Modernization Act (FSMA) and a proposed extension of the compliance date for FDA’s new food label rules.  Take a look below at some of the regulatory highlights that occurred this year.

FDA Removed 28% of Food Facility Registrations from its Database

Between January 2016 and February 2017, FDA removed 57,720 food facility registrations from its database.  The drop in registrations was likely caused by facilities not properly registering before the December 2016 deadline and U.S. Agents of foreign facilities not confirming acceptance of this role with FDA.

Australia Received Systems Recognition with U.S. FDA

In April, FDA recognized the Australian Department of Agriculture and Water Resources as having a comparable Food Safety System to the United States.  Australia follows New Zealand and Canada as the third country to receive this recognition.  U.S. Importers may receive exemptions from certain requirements in their Foreign Supplier Verification Programs (FSVPs) if their suppliers are in “good compliance standing” with a recognized country’s regulating authority.

As of this writing, the three recognized countries have not published lists of firms in good compliance standing.  As a result, suppliers in these countries are unable to benefit from the competitive advantage that more relaxed FSVP requirements for importers would grant them.

The FSVP Compliance Deadline for Most US Importers Passed

The first compliance deadline for the FSVP Rule passed on May 30, 2017.  Among other requirements, covered importers must monitor and document their foreign suppliers’ FDA compliance, evaluate the level of health risk their suppliers pose, and conduct appropriate verification activities relative to this evaluation.  In August, FDA began inspecting covered importers for their compliance with FSVP requirements.  The next FSVP compliance date is March 19, 2018.

Compliance Dates Passed under the Preventive Controls Rules

Larger animal food and smaller human food businesses were required to develop and implement written Food Safety Plans by September 18, 2017.  These plans, overseen by a “Preventive Controls Qualified Individual” (PCQI), involve an analysis of reasonably known or foreseeable hazards and preventive controls for these hazards.  Smaller animal food businesses were required to begin implementing Current Good Manufacturing Practices (CGMPs) by this deadline.

FDA Proposed Extension of Label Rule Compliance Dates

In September, FDA proposed an extension of the compliance deadline for new food labeling rules to January 1, 2020 for food manufacturers grossing $10 million or more in annual sales.  Smaller businesses would be provided an additional year.  Despite the proposed extension, we urge facilities to take steps toward compliance now. FDA issued this proposal after manufacturers expressed concerns over being able to comply with the initial deadline of July 2018.

FDA Proposed to Revoke Authorized Health Claim for Soy Protein

FDA issued a proposal to revoke an authorized health claim linking soy protein to a decreased risk of coronary heart disease.  Since the claim’s authorization in 1999, the “totality of scientific evidence” surrounding the relationship has yielded inconsistent findings.  This caused FDA to determine that it did not present the significant scientific agreement required of an authorized health claim.

FDA Issued Draft Guidance for Refusal of Inspection

In December, FDA issued a guidance outlining the Agency’s interpretation of the term “refusal of inspection.”  FDA states that, among other actions, failure to respond to an inspection request within 24 hours may constitute a refusal.  Food facilities that refuse inspection are placed under Import Alert, and their products are refused at the port of U.S. entry.

Registrar Corp remains committed to keeping the food industry informed on pressing regulatory matters and will continue to issue critical information in 2018.  The numerous requirements that came into effect this year and those approaching in 2018 may be overwhelming.  Registrar Corp can offer assistance.  Call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

FDA Issues Final Rule on Safety and Effectiveness of Triclosan in Health Care Antiseptics

On December 20, 2017, The U.S. Food and Drug Administration (FDA) published a final rule that will prohibit the inclusion of commonly used ingredient triclosan and 23 other active ingredients in antiseptics for health care environments.  Following the rule’s compliance deadline of December 20, 2018, health care antiseptics containing any of the covered ingredients will not be permitted to enter interstate commerce without FDA approval of a new drug application (NDA).  You will find a list of the covered ingredients below.

The scope of this rule only applies to antiseptic products (i.e. washes, scrubs, rubs, and skin preparations) used by health care professionals in health care settings.  Antiseptic products intended for use by consumers are covered by two separate rules, one of which had a compliance deadline in September 2017.

Why are these ingredients prohibited?

The covered ingredients were initially part of a 1994 tentative final monograph for OTC antiseptic drug products.  A 2015 proposed rule called for additional data to support the safety and effectiveness of these ingredients for use in health care antiseptic products.  FDA did not receive any additional data, and the available scientific evidence surrounding the ingredients was insufficient to support a determination that they are generally recognized as safe and effective (GRASE).

FDA is delaying final rulemaking for at least one year on benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol (also known as ethanol or ethyl alcohol), isopropyl alcohol, and povidone-iodine.  The Agency has stated that a determination for these ingredients will be dependent upon whether ongoing studies are eventually completed, and if so, when they are completed.

Not sure how this rule applies to your health care antiseptics?  Registrar Corp’s Regulatory Specialists can conduct a full review of your antiseptic product’s ingredients and labeling.  We review your product’s active ingredients to ensure that they conform to the requirements specified in the applicable FDA monographs for antimicrobial drug products. We also inspect your labeling to ensure that its content and formatting conform to numerous FDA drug regulations.  In addition to an extensive report of suggested revisions, you will receive a print-ready label incorporating these changes.  For assistance, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

Ingredients Deemed Not Generally Recognized as Safe and Effective under the Health Care Antiseptic Final Rule:

Chlorhexidine gluconate
Mercufenol chloride
Methylbenzethonium chloride
Secondary amyltricresols
Sodium oxychlorosene
Iodophors (Iodine-containing ingredients)
• Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
• Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
• Iodine tincture USP
• Iodine topical solution USP
• Nonylphenoxypoly (ethyleneoxy) ethanoliodine
• Poloxamer—iodine complex
• Undecoylium chloride iodine complex
Triple dye
Combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative
Combination of mercufenol chloride and secondary amyltricresols in 50 percent alcohol

FDA Announces New Enforcement Approach to Drugs Labeled as Homeopathic

Once small and specialized, homeopathic drugs now comprise a nearly $3 billion industry.  Following an increase in reported health concerns stemming from these products and a flurry of unsubstantiated health claims surrounding the industry, the U.S. Food and Drug Administration (FDA) is taking new measures to curb the widespread distribution of potentially harmful drugs labeled as homeopathic.

What are Homeopathic Drugs?

Homeopathy is a form of alternative medicine based on the principle of remedying health conditions using diluted solutions of substances that produce similar symptoms in a healthy patient.

The Food, Drug, and Cosmetic (FD&C) Act defines articles recognized in the official Homeopathic Pharmacopoeia of the United States as drugs.  FDA states that homeopathic drugs “are subject to the same requirements related to approval, adulteration and misbranding as any other drug product.”

Despite this, the uniqueness of homeopathic drugs delayed them from the 1972 over-the-counter (OTC) drug review, which determined the safety and effectiveness of most OTC drugs on the U.S. market.  Even now, FDA has not conducted a formal review of homeopathic drugs.  Since 1988, a FDA Compliance Policy Guide (CPG) establishes provisions under which these products may be marketed without the prior FDA approval required of other drug products.

Why is FDA Cracking Down on Homeopathic Drugs?

Numerous homeopathic drugs contain potentially harmful ingredients.  As recently as September 2017, a homeopathic drug facility received a Warning Letter, citing failure to establish adequate in-process controls for products containing multiple potentially toxic ingredients.  One such ingredient was Nux vomica, a plant bearing constituents commonly used for rat poison.

Throughout 2017, FDA issued at least four additional letters to homeopathic drug manufacturers who failed to adequately test and control potentially toxic substances in their products.  FDA charged the drugs in question as adulterated.

New Enforcement Approaches to Homeopathic Drugs

In addition to FDA, the U.S. Federal Trade Commission (FTC) has issued measures to mitigate the prevalence of unsubstantiated health claims made by homeopathic drug manufacturers. A 2016 FTC Enforcement Policy Statement requires homeopathic drug labeling to communicate that “there is no scientific evidence that the product works.”  The label must also indicate that “the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”

A December 2017 FDA draft guidance explains that the Agency intends to prioritize enforcement on products that are known to cause harm to patients, including those with reported health issues and those deemed adulterated under section 501 of the FD&C Act.

FDA states it will also focus increased attention on homeopathic drugs with less overt health concerns.  According to the guidance, unapproved drugs intended to treat serious or life-threatening conditions may cause a patient to delay or discontinue treatment already generally recognized as safe and effective (GRASE). Homeopathic drugs designed for vulnerable populations (e.g. infants and the elderly) may pose significant health risks even in small concentrations, in spite of treatments that have already been determined GRASE.  For this reason, these drug categories may see increased regulatory enforcement.

In the previously referenced Warning Letters, FDA maintains that “nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval.”  The letters and newly issued guidance suggest that FDA intends to expand efforts to hold homeopathic drug manufacturers accountable to the regulations derived from the FD&C Act.

Registrar Corp is a consulting firm that assists drug companies with U.S. FDA regulations.  Our Regulatory Specialists can assist with FDA registration and drug listing, labeling requirements, and other drug regulations.  For assistance or questions call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Upcoming Changes to FDA Electronic Medical Device Reporting (eMDR) in 2018

Medical device manufacturers and importers are required to report “adverse events” to FDA when their device has caused or contributed to death or serious injury.  An “adverse event” is when a device has a malfunction that could cause death or serious injury.  Importers report this information to the manufacturer.  The U.S. Food and Drug Administration (FDA) has announced that it will update certain codes used for Adverse Event Reporting through the Electronic Medical Device Reporting (eMDR) system on April 6, 2018.

The Agency will replace the codes for FDA Device Problem, Manufacturer Evaluation Method, Manufacturer Evaluation Result, and Manufacturer Evaluation Conclusion with similar codes established by the International Medical Device Regulators Forum (IMDRF).

IMDRF has released public references to help map FDA codes to the new codes during the interim before the update.  For example, the current FDA Device Problem Code 2682 refers to an “issue associated with the interaction between the patient’s physiology or anatomy and the device that affects patient and/or device.” This code corresponds to and will be replaced by IMDRF code A0101, a “problem associated with the interaction between the patient’s physiology or anatomy and the device that affects the patient and/or the device.”

Despite this mapping, reporting parties will not be able to rely on FDA codes after the update.  Some IMDRF codes do not have a current FDA equivalent, and FDA has further stated that the submission of retired FDA codes following the update will be rejected by the eMDR system.   As such, reporting parties should familiarize themselves with the IMDRF codes for a smooth transition into these changes.

If you are a reporting party in need of assistance, Registrar Corp can guide you through the eSubmitter software and facilitate your Adverse Event Report submission to eMDR.  Registrar Corp offers Adverse Event Reporting assistance at no fee to clients of our U.S. Agent Service.  Call us at +1-757-224-0177.  Alternatively, you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

FDA Releases FY 2017 Inspectional Observations; Registrar Corp Reports on Common Food Safety Violations

5 Inspection Violations Commonly Found by FDAThe U.S. Food and Drug Administration (FDA) recently released its inspectional observation data for fiscal year (FY) 2017.  The data presents an overview of violations cited by FDA during routine food facility inspections from October 2016 through September 2017.  FDA consulting firm Registrar Corp compiled the most commonly cited food safety violations:

  • Lack of Effective Pest Exclusion/Screening – The facility does not take effective measures to protect food against contamination from pests or exclude pests from food production areas.
  • Sanitation Monitoring – The facility does not monitor sanitation conditions and practices frequently enough to conform to current good manufacturing practices (CGMPs).  Some factors that should be monitored include the safety of water coming into contact with food and food contact surfaces, the condition and cleanliness of food contact surfaces, and the measures used to prevent cross-contamination from unsanitary objects.
  • Plant Cleanliness – The facility fails to maintain cleanliness of the premises, or the facility is not constructed in a way that allows for proper sanitation or maintenance of floors, walls, and ceilings.
  • HACCP Plan Implementation – A facility manufacturing seafood or juice fails to implement procedures in its HACCP plan. These may include monitoring critical control points of food hazards, verifying the adequacy of the plan’s hazard control, or maintaining records as required by 21 CFR Part 123
  • Reasonable Precautions – The facility does not take precautions to prevent production procedures from contaminating food.  Reasonable precautions may include monitoring food processing time and temperature or monitoring manufacturing operations, such as freezing or heat processing.

The violations listed above are nearly identical to the most common violations cited in FY 2016 and FY 2015.  Food facilities should use this pattern to anticipate what areas in their daily operations may require further review before a FDA inspection.

It is worth mentioning that the 2017 list is the first to include violations related to FDA’s Preventive Controls Rules and Foreign Supplier Verification Program (FSVP) Rule, both of which had compliance deadlines in 2017.  Most food facilities are now required to have implemented HARPC food safety plans, and many importers are required to have FSVPs. Despite the first FSVP compliance deadline passing as recently as May 2017, failure to develop an FSVP was cited 108 times.  With the next FSVP deadline landing in March 2018, it is probable that FSMA violations may make their way to the top next year.

Inspection violations can result in Warning Letters, placement on Import Alert, suspension of facility registration, and other enforcement actions.  With proper preparation and guidance, these food safety issues can be corrected before FDA visits a facility.  Registrar Corp’s Food Safety Specialists can conduct a mock FDA inspection of your facility to identify potential food safety violations.  Our expert, onsite assistance can guide your facility with knowledge and tools to have a successful FDA inspection.  For more information, visit our site or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

This article was originally published as a press release.

FDA Requires Responses to Inspection Requests within 24 Hours, According to New Inspection Refusal Guidance

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance that outlines their interpretation of the term “refusal of inspection.”  According to the guidance, FDA requires food facilities receiving notice of FDA inspection to confirm acceptance of the inspection within 24 hours. Failure to confirm within 24 hours may be deemed refusal of inspection, resulting in refusal of that facility’s future food shipments to the US.  Further, any attempts to limit or condition the inspection in any way likewise may be deemed a refusal of inspection, with the same harsh consequences.

What are the Consequences of Being Deemed a Refusal?

Facilities that refuse inspection are placed under Import Alert 99-32, and their food articles face refusal of admission at the port of U.S. entry.  In addition, their FDA registration may be suspended.

How Can I Prevent Being Deemed a Refusal?

The recent guidance amplifies the importance of understanding FDA’s expectations for the inspection process and having a reliable U.S. Agent as a guide.  Before the inspection begins, the Agency may interpret actions such as not agreeing to an inspection start date or rescheduling an inspection without reasonable explanation as attempts to circumvent the inspection.  Upon receiving a notice of inspection, a facility should work with their U.S. Agent to respond to FDA promptly and cooperatively.

During the inspection, a facility should maintain this cooperation with the FDA inspector.  Any attempts to interfere with or delay the inspection, such as limiting the inspector’s observations to certain areas of the plant or omitting requested documents, may constitute refusal.  Facilities should ensure that they accommodate the inspector’s requests and refrain from any actions that might limit a full observation of daily operations.

Our Facility Is Under Import Alert for Inspection Refusal.  What Can We Do?

To seek removal from the Import Alert 99-32 Red List, a facility must petition for inspection by FDA.  The guidance states that for some facilities, scheduling an inspection after an initial refusal may take at least one year.  Given this, full cooperation with FDA inspection is imperative to avoid loss of profits from an avoidable Import Alert.

Proper guidance from a third party experienced in FDA regulations can prove invaluable to a facility facing inspection.  Registrar Corp’s trained Regulatory Specialists are knowledgeable in FDA inspections and can conduct a Mock FDA Inspection of your facility.  Our experts can help identify potential food safety issues to fix before an inspection and educate facility staff on FDA expectations. For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Registrar Corp can act as your U.S. Agent to help you promptly schedule inspection with FDA, as well as provide your facility a host of additional benefits, including biennial registration, detention assistance, and compliance monitoring.


Why Food Facilities Should Get Off FDA Import Alert Before March 2018

The U.S. Food and Drug Administration (FDA) requires most U.S. importers of food and beverages to develop and implement Foreign Supplier Verification Programs (FSVPs). Covered importers must document their foreign suppliers’ FDA compliance, including whether or not each supplier is subject to a FDA Import Alert.

Under FSVP, importers must only import from suppliers whom they have evaluated and approved. FDA requires verification activities outlined in a FSVP to be decided by the level of supplier risk determined from this evaluation.  An Import Alert increases the probability that the importer must conduct more comprehensive verification activities to ensure the safety of a supplier’s products, such as onsite audits or sampling.  In some cases, the importer may be unable to approve a supplier because they are under Import Alert.  For these reasons, suppliers not on alert receive a competitive advantage in the market.

The next FSVP deadline is March 19, 2018, which applies to U.S. importers whose suppliers have fewer than 500 full-time equivalent employees. Before the deadline, food facilities outside of the United States should ensure that they are not subject to an Import Alert that may cause their U.S. Importers to not approve them.

What is an Import Alert?

Products on Import Alert face detention without physical examination (DWPE) at the port of entry. FDA issues Import Alerts when patterns of non-compliance from a specific business or country give the Agency reasonable belief that future shipments may violate regulations.

For example, FDA sampled 16 shipments of dried peppers from ten different shippers in Mexico in 1988.  FDA found excessive mold in 14 of those samples.  This led to the publication of Import Alert #24-11, which subjects all shipments of dried peppers from Mexico to DWPE unless the shipper’s product is exempt.  This is just one instance of over 240 active FDA Import Alerts.

How do I know if my products are on Import Alert?

FDA does not directly notify a facility that it is under Import Alert.  Instead, the Agency maintains a public database of Import Alerts with records of which products from which facilities are subject to DWPE. However, determining if products are on Import Alert may require time-consuming searches through numerous alerts for any facilities a given business might have a stake in.  Registrar Corp’s FDA Compliance Monitor is a simple alternative that allows businesses to track all of their facilities at once and receive a detailed report of any alerts their products may be under.

My Products are on Import Alert.  How do I get them removed?

A business may petition FDA for exclusion from an Import Alert by demonstrating evidence of compliance that overcomes the apparent violation detailed in the Alert. A common misconception is that a facility is excluded from Import Alert after five consecutive non-violative shipments are released by FDA.  This is only a small component of a larger process involving other, potentially extensive requirements.

The specific requirements for a petition vary, and are outlined in the guidance issued with an individual Import Alert.  These may include documentation of revised food safety plans, revised labeling or formulations, changes implemented in the manufacturing process, or documentation of compliance with a government agency regulating food in the facility’s home country.

Many businesses can be intimidated by the extensive requirements of an Import Alert petition.  These businesses may remain under Import Alert, facing DWPE and difficulties satisfying the requirements of an importer’s FSVP, even if they are not in violation of the specified regulations at the time.  Despite a solution to the problem, some businesses might have no idea how to begin a petition.

Registrar Corp’s Regulatory Specialists are experienced in developing Import Alert petitions and can help you draft and compile the necessary documentation for Import Alert exclusion.  Additionally, importers and suppliers can try Registrar Corp’s FDA Compliance Monitor free for 60 days to see which of their facilities may be on alert.  For assistance, call us at +1-757-224-0177 or speak with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.


FDA Publishes Final Guidance for UDI Direct Marking Requirements

The U.S. Food and Drug Administration (FDA) requires devices intended to be reprocessed or devices intended to be used more than once by multiple patients to physically bear a permanent unique device identifier (UDI) marking that lasts the duration of the devices’ expected lifetime.  This is known as UDI direct marking.  FDA recently published a final guidance on requirements for the direct marking of medical devices.

According to the guidance, the device labeler is responsible for direct marking a device with a UDI in either human readable or automatic identification and data capture (AIDC) format. The method of marking, such as etching or attaching a permanent tag, is decided at the labeler’s discretion and must account for wear from the intended use of the device.

What is New in the Final Guidance?

FDA recently conducted a webinar explaining the key differences between the final guidance of this regulation and the draft guidance published in 2015.  Notable changes include:

  • FDA established that a device is “intended to be reprocessed” if it is intended to undergo high-level disinfection and/or sterilization before or between each use. High-level disinfection is defined in this guidance as a process in which a sterilant kills “all forms of microbial life, except for large numbers of bacterial spores.”
  • FDA emphasized that implants, which are not mentioned in the draft guidance, do not fall within the scope of UDI direct marking regulation.
  • FDA does not intend to enforce UDI labeling and direct marking compliance for devices that were consigned or loaned to a healthcare facility before the devices’ respective UDI labeling compliance dates. This also applies to devices in the possession of a sales representative pending sale under the same conditions.
  • In June 2017, FDA issued a letter outlining intentions to extend the UDI labeling compliance date for covered class I and unclassified devices to September 24, 2020. During the webinar, the Agency clarified that it does not intend to enforce direct marking requirements for these devices until September 24, 2022.

Remaining Compliance Dates for UDI Direct Marking

Unless exempt from UDI direct marking requirements, the compliance date for class I and unclassified devices is as established above, and the compliance date for direct marking of class II devices remains September 24, 2018, as outlined in the UDI final rule.  Devices manufactured before their respective UDI labeling compliance dates are provided three additional years to comply with labeling and direct marking requirements.

Not sure how UDI requirements apply to your device?  Registrar Corp’s Regulatory Specialists can help determine whether your device requires direct marking and can submit device information to FDA’s Global Unique Device Identifier Database (GUDID).  For assistance, call us at +1-757-224-0177 or speak with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Additional UDI Resources: 

Five Steps to FDA UDI Compliance

How Many UDIs Will You Need?

UDI Labeler Responsibilities

FDA Unique Device Identifier Requirements

FDA Proposes to Revoke Authorized Health Claim for Soy Protein

The U.S. Food and Drug Administration (FDA) recently proposed to revoke an authorized health claim regarding the relationship between soy protein and decreased risk of coronary heart disease (CHD). According to a statement from Dr. Susan Mayne, FDA drafted this proposal after observing inconsistencies in published scientific data surrounding the claim.

Why is FDA changing the status of this claim?

FDA authorizes a petitioned health claim by examining the “totality of scientific evidence” surrounding the relationship between a specified substance and a disease (e.g. fruits and vegetables and the reduced risk of certain cancers).  Publically available data must demonstrate “significant scientific agreement” (SSA) among qualified experts for FDA to authorize the claim.

In the case of soy protein and CHD, Mayne states that “the totality of currently available scientific evidence calls into question the certainty of this relationship.”  Studies conducted following the claim’s authorization in 1999 yielded inconsistent findings between the two and helped influence FDA’s decision to issue the proposed rule.

What does this mean for my food labeling?

Substance/disease relationships that do not meet the standard of SSA may become qualified health claims through petitions to FDA that provide credible scientific support. Such claims require a disclaimer or other qualifying language on a product’s labeling that convey the level of scientific support for the relationship. Examples of qualified health claims include:

  • “Vitamin C may reduce the risk of colon cancer. The scientific evidence supporting this claim is persuasive, but not conclusive.”
  • “Although the evidence is not conclusive, tomato products, which contain lycopene, may reduce the risk of prostate cancer.”
  • “Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive.”

Should FDA finalize this rule and a petition for the soy protein and CHD relationship provide sufficient scientific support, the Agency may consider it a qualified health claim. FDA issues Letters of Enforcement Discretion that outline specific language, similar to the examples above, for making qualified health claims on a product’s label.  Food manufacturers who previously displayed the authorized claim may need to adjust their labeling to reflect potential changes.

While this proposed rule does not enact certain or immediate changes, food manufacturers should be conscious of health claims on their labeling, especially when updating to comply with FDA’s new label rules. Labels presenting claims that are not authorized or qualified are considered misbranded.  Marketing a misbranded food product in the United States is a prohibited act that may be met with Warning Letters, detentions, or other enforcement actions.

An examination of your labeling by a third party experienced in FDA regulations can be an invaluable business decision. Registrar Corp’s Regulatory Specialists can conduct a full review of your product’s labeling.  In addition to a detailed report of recommended revisions, you will receive a print-ready file of your revised label.  For assistance, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.