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UDI Exceptions, Alternatives and Time Extensions

The UDI rule provides a method for labelers to request exceptions, alternatives, and time extensions to UDI requirements. FDA plans to make decisions on requests for exceptions, alternatives and time extensions available on this page.

For example, class I devices that are exempt from Good Manufacturing Practices (GMP) requirements do not need to be labeled with a UDI.

General exceptions from the requirement for the label of a device to bear a unique device identifier (§ 801.30)

The UDI rule provides exceptions from the requirements of § 801.20 for certain categories of devices. A device within one or more of these exceptions is not required to bear a UDI. A labeler of a device identified in § 801.30 is not required to request an exception from FDA.

Request for an exception from or alternative to a UDI requirement (§ 801.55)

A labeler may submit a request for an exception from or alternative to the requirement for the label of a device to bear a unique device identifier (§ 801.20) or other UDI requirement under 21 CFR 801 Subpart B (Labeling Requirements for Unique Device Identification) for a specified device or a specified type of device.

The Center Director may grant an exception or alternative if an exception is appropriate because the requirements of 21 CFR 801 Subpart B are not technologically feasible, or that an alternative would provide for more accurate, precise, or rapid device identification than the requirements of 21 CFR 801 Subpart B or would better ensure the safety or effectiveness of the device that would be subject to the alternative. If we grant an exception or alternative, we may include any safeguards or conditions deemed appropriate to ensure the adequate identification of the device through its distribution and use.

FDA may initiate and grant an exception or alternative if we determine that the exception or alternative is in the best interest of the public health. Any such exception or alternative will remain in effect only so long as there remains a public health need for the exception or alternative.

The Center Director may rescind an exception or alternative granted under § 801.55 if, after providing an opportunity for an informal hearing, the Center Director determines that the exception or alternative no longer satisfies the criteria described or that any safeguard or condition required under § 801.55 has not been met.

Any labeler may make use of an exception or alternative granted under § 801.55, provided that such use satisfies all safeguards or conditions that are part of the exception or alternative. To facilitate such use, the FDA plans to make its decisions on requests for exceptions or alternatives available to the public.

To request an exception from or alternative to the requirements of 21 CFR 801 Subpart B:

  • Submit a UDI exception/alternative inquiry below. In response, the FDA UDI Help Desk will email instructions for requesting an exception from or alternative to a UDI requirement. If you do not receive an immediate reply in your inbox, please check the spam/junk folder. If the email was sent to your spam/junk folder, please adjust your filter to recognize the UDI Help Desk as a contact.
  • Review the instructions and include the necessary information in your request.
  • Submit the request as indicated in the instructions. An FDA UDI Help Desk Analyst will respond to your request.

Help Desk Exceptions/Alternatives Inquiry Form

All fields are required.

According to 21 CFR 801.55 (a), when submitting your request for an exception or alternative you must:

  • Identify the device or devices that would be subject to the exception or alternative;
  • Identify the provisions of 21 CFR 801 Subpart B that are the subject of the request for an exception or alternative;
  • If requesting an exception, explain why the requirements of 21 CFR 801 Subpart B are not technologically feasible;
  • If requesting an alternative, describe the alternative and explain why it would provide for more accurate, precise, or rapid device identification than the requirements of 21 CFR 801 Subpart B or how the alternative would better ensure the safety or effectiveness of the device that would be subject to the alternative;
  • If known, provide the number of labelers and the number of devices that would be affected if we grant the requested exception or alternative; and
  • Provide other requested information needed to clarify the scope and effects of the requested exception or alternative.

Time extension for a class III medical device or a device licensed under the Public Health Service Act

A labeler may submit a request for an extension (up to one year) of the compliance dates for a class III medical device or a device licensed under the Public Health Service Act. Such a request should be submitted no later than June 23, 2014.

To request an extension of the compliance date for a class III medical device or a device licensed under the Public Health Service Act:

  • Submit an extension of compliance date inquiry using the form below. The FDA UDI Help Desk will email instructions for requesting an extension of the compliance date. If you do not receive an immediate reply in your inbox, please check the spam/junk folder. If the email was sent to your spam/junk folder, please adjust your filter to recognize the UDI Help Desk as a contact.
  • Review the instructions and include the necessary information in your request, submit the request as indicated in the instructions.
  • An FDA UDI Help Desk Analyst will respond to your request.

The FDA plans to make decisions related to extensions of the UDI compliance date public.

Help Desk Extension of Compliance Date Inquiry Form

All fields are required.

When submitting your request for an extension, please:

  • Identify the device or devices that would be subject to the extension
  • Provide, if known, the number of labelers and the number of devices that would be affected if we grant the extension;
  • Explain why such an extension would be in the best interest of the public health; and
  • Provide other requested information needed to clarify the scope and effects of the requested extension.

Continued use of FDA labeler code (§ 801.57)

The use of National Health Related Items Code (NHRIC) and National Drug Code (NDC) numbers for devices is being phased out over a time period that corresponds with the compliance dates for UDI requirements. On the date a medical device must bear a UDI on its label, any NHRIC or NDC numbers assigned to the device are rescinded and may no longer be provided on the device label or package. If a device is not required to have a UDI on its label, any NHRIC or NDC number assigned to it is rescinded and may no longer be on the device label or package after September 24, 2018.

A labeler may request continued use of an FDA labeler code under a system for the issuance of UDIs provided that such use of the FDA labeler code is consistent with the framework of the issuing agency that operates that system, as described under 21 CFR 801.57(c). Such requests must be submitted no later than September 24, 2014.

To request continued use of an FDA-assigned NHRIC or NDC labeler code:

  • Submit a continued use labeler code inquiry below. The FDA UDI Help Desk will email instructions for requesting the continued use of an FDA-assigned labeler code. If you do not receive an immediate reply in your inbox, please check the spam/junk folder. If the email was sent to your spam/junk folder, please adjust your filter to recognize the UDI Help Desk as a contact.
  • Review the instructions and include the necessary information in your request, submit the request as indicated in the instructions
  • An FDA UDI Help Desk Analyst will respond to your request.

Help Desk Continued Use of FDA Labeler Code Form

All fields are required.

According to 21 CFR 801.57(c), when submitting your request to continue use of an FDA-assigned labeler codes you must provide:

  • The name, mailing address, email address, and phone number of the labeler who is currently using the labeler code.
  • The owner/operator account identification used to submit registration and listing information to FDA’s Unified Registration and Listing System (FURLS). Please note this is different than the owner/operator number.
  • The FDA labeler code that the labeler wants to continue using.

 

Page Last Updated: 10/02/2014
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