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New Developments in UDI and GUDID Regulations

Registrar Corp is committed to keeping industry up to date on FDA’s Unique Device Identifier  (UDI) requirements and recently attended the 2018 UDI Conference in Baltimore. The following blog summarizes new and updated information related to UDI and Global Unique Device Identification Database (GUDID) regulations.

Background

In September 2013, the U.S. Food and Drug Administration (FDA) issued a final rule, which requires most medical devices to carry a UDI. A UDI is a numeric or alphanumeric code consisting of a device identifier (DI) and a production identifier (PI) that must be placed on the device label and on the device packaging. The labeler is responsible for complying with this rule.

Compliance Deadlines

The compliance deadlines for Class II devices and for Class III devices have already passed. In June 2017, FDA informed industry that it intended to extend the compliance deadline for these devices due to complex policy and technical issues, among other things.  In January 2018, the Agency issued a guidance document detailing how it would utilize its enforcement discretion:

For Class I and unclassified devices manufactured and labeled on or after September 24, 2018, FDA intends to enforce:

  • UDI labeling, GUDID Data Submission, and Standard Date Format requirements beginning September 24, 2020
  • Direct Marking requirements beginning September 24, 2022.

For finished class I and unclassified devices manufactured and labeled before September 24, 2018, FDA intends to enforce:

  • UDI labeling, GUDID Data Submission, and Standard Date Format requirements beginning September 24, 2021.
  • Direct Marking requirements beginning September 24, 2022.

 

Recent Enhancements and Fixes to GUDID Submission Process

 

GUDID Coordinators Now Able to Correct Errors After the DI Record Grace Period

The labeler of a device with a UDI is responsible for submitting information about the device to the Global Unique Device Identification Database (GUDID), a public database that contains important identification information about every device with a UDI. In order to ensure data quality, FDA has taken steps to make correcting errors by editing device records easier.

Previously, unlimited edits were only possible during the 30 day grace period following initial publication. After the grace period, edits could only be made through a difficult process. Now, the GUDID Coordinator user has the ability to “unlock” device records. Once previously submitted device records have been unlocked, errors may be corrected. It should be noted that the records’ history will be saved and the public will be able to see what edits have been made.

 FDA to make Premarket Numbers Public

FDA has announced plans to grant the public access to the data in the “FDA Premarket Submission Number” and “Supplement Number” fields (premarket numbers) in the GUDID Device Identifier (DI). This data is tentatively scheduled to be made public on July 2, 2018. FDA recognizes that this information may be sensitive and will give labelers the option of keeping their premarket numbers confidential. Specifically, FDA will use the confidentiality information that is included in the device listing information submitted to the FDA Unified Registration and Listing System/ Device Registration and Listing Module (FURLS/DRLM). If a proprietary name is marked confidential in DRLM as part of the device listing information, then FDA does not plan to make the corresponding premarket numbers in GUDID DI record(s) public.

Labelers who would prefer to keep the their premarket numbers confidential may find it advisable to carefully scrutinize and potentially alter the confidentiality designations assigned to the DRLM proprietary names in their device listing records in order to ensure that these designations correspond to their preferences.

Meeting FDA GUDID and UDI Requirements

The deadlines for complying with FDA GUDID and UDI requirements are approaching or have already passed. Therefore, it is prudent for medical device labelers to take measures to ensure that they are in compliance with these complex regulations. Medical device labelers may wish to seek the assistance of Registrar Corp’s Regulatory Specialists, who possess expert knowledge of relevant FDA regulations and can provide guidance on which UDI deadlines and requirements apply to particular devices.

Registrar Corp can provide assistance  by acting as a facility’s Regulatory Contact for UDI purposes, submitting the required device information to GUDID on behalf of the labeler, or by altering the confidentiality information submitted to DRLM in order to ensure that premarket numbers remain confidential.

For more information, contact us by phone at +1-757-224-0177 or chat with a Regulatory Adviser 24 hours a day: www.registrarcorp.com/livehelp.

FDA Removed Nearly 10% of Medical Device Establishments from its Registration Database

The U.S. Food and Drug Administration (FDA) removed 2,546 medical device establishments from its active registration database.  As of February 19, 2018, the FDA database contained 24,578 registered establishments, compared to 27,124 registered establishments on February 2, 2018.

Why Were These Registrations Removed?

Establishments are typically removed due to failure to renew their annual FDA registrations.  FDA requires medical device establishments to renew their registrations between October 1 and December 31 of each year.  Within two or three months, FDA typically removes any establishments that do not properly renew.

Establishments located outside of the United States must designate a U.S. Agent for FDA communication as part of their annual registration.  During the recently passed renewal period, listed U.S. Agents were required to confirm their designation with FDA.  If a U.S. Agent failed to confirm their designation, FDA did not consider the establishment’s registration complete.

Marketing a medical device in the United States without a valid FDA registration is a prohibited act that may result in detention or refusal of shipments and other FDA enforcement actions.  Many establishments do not realize that their FDA medical device registration is invalid until their shipments are detained.

Registrar Corp can verify that your FDA medical device registration is valid for 2018 at no cost. Simply complete the form below.  For questions or assistance with FDA medical device regulations, call: +1-757-224-0177 or chat with a Regulatory Advisor 24/7: www.registrarcorp.com/livehelp

Verify your FDA Registration:

FDA Issues Guidance on Medical Device Accessories

Medical device manufacturers commonly question whether the U.S. Food and Drug Administration (FDA) considers their product a medical device “component” or “accessory.”  Given that accessories can be classified separately from the parent devices they function with, the distinction is important.  In December, FDA issued a guidance on accessory classification policy that helps clarify this distinction.

Component or Accessory?  What is the Difference?

CFR 21 820.3(c) defines a “component” as “any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.”  For example, a stethoscope contains multiple parts, including a diaphragm, bell, and tubing.  When packaged in whole with the stethoscope, these parts would be considered medical device components that comprise a finished medical device.

In contrast, FDA clarifies that an “accessory” is a separate, finished device intended to “support, supplement, and/or augment the performance” of at least one parent device.  Accessories might be marketed individually for use with a specific device type and may be a different class than their parent device.

For instance, an endoscope, which is used to examine a patient’s internal organs, receives its own medical device classification.  An individually marketed endoscopic snare may be attached in order to remove harmful objects from a patient during endoscopy.  Because the snare is marketed for intended use with a parent device and it supplements the parent device by adding functionality, the device would likely be considered an accessory.

Likewise, cushions for motorized wheelchairs are often marketed separately with the intent to address specific physiological concerns of the device user.  The cushion augments the parent device by improving convenience for the device user.  While the motorized wheelchair may be a class II device, the cushion may present lower risk when used with the parent device.  Dependent on FDA’s assessment of this risk, the cushion might be considered a class I medical device accessory, subject to different requirements than its parent.

FDA’s New Accessory Classification Process

FDA generally determines classification of accessories in one of two ways.  An accessory may be included in the same classification as its parent device through 510(k) Premarket Notification, Premarket Application, or express inclusion in the classification regulation of the parent device. Other cases may involve the issuance of a separate classification regulation when FDA considers an accessory to have a different level of risk than its parent device.

The FDA Reauthorization Act of 2017 allows for the classification of accessories based upon the level of risk posed when used as intended and the level of regulatory controls necessary to provide reasonable assurance of safety and effectiveness.  Manufacturers may now submit an Accessory Classification Request to FDA to receive appropriate classification of their device accessory.  An Accessory Classification Request includes a proposal to FDA that, among other aspects, identifies the accessory, the proposed class of the accessory, and the necessary information to establish the risk the accessory poses.

Medical device classification serves an important role in deciding a device’s FDA requirements, such as the premarket processes it may be subject to or when it is required to comply with certain regulations.  Lower device classes may even receive exemption from certain premarket requirements.

For proper accessory classification, Registrar Corp’s Regulatory Specialists can guide you through compiling the documentation required for a FDA Accessory Classification Request.  Additionally, if you manufacture an accessory and would like to preserve trade secrets from the manufacturer of the parent device, we can assist in the submission of a Medical Device Master File to FDA.  For more information, 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 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.

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 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

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 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.

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.

FDA Extends UDI Compliance Date for Class I Devices to 2020

On June 2, 2017, the U.S. Food and Drug Administration issued a letter announcing that the Agency intends to extend the Unique Device Identification (UDI) compliance dates for class I and unclassified devices (excluding implantable, life-supporting or life-sustaining devices) to September 24, 2020 (two years after the original compliance date).  FDA plans to solidify this extension with a guidance document regarding its enforcement discretion, but the Agency wanted to inform industry of its decision as early as possible.

Device labelers are responsible for implementing FDA’s UDI requirements.  According to the letter, many labelers asked FDA for an extension upon realizing the substantial amount of time the process takes.  The letter also notes that “providing accurate and timely support to labelers has also been challenging, due to the sheer number and wide diversity of devices,” which leads us to believe many labelers are having difficulty completing the process on their own.

With this in mind, it’s prudent for device labelers to begin preparing for the 2020 UDI compliance date as early as possible to ensure they meet the requirements on time.  Registrar Corp’s Regulatory Specialists can help you navigate the UDI process, including obtaining a DUNS number, calculating how many UDIs you will need, and more.  For assistance, simply complete the form below: