UDI Exceptions, Alternatives and Time Extensions

Help Desk Exceptions/Alternatives Inquiry

If you have questions related to UDI and GUDID, complete the following information to submit your question to the FDA UDI Help Desk.

Please complete all fields to submit to the FDA UDI Help Desk:

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.
  • As applicable, we encourage you to:
  1. Provide pictures or diagrams of your label, packaging and/or product to more diclearly illustrate the situation you are describing in your request. Doing this often reduces the need for us to ask for clarification and can expedite processing of your request.
  2. Clearly denote confidential or protected information included in your request. FDA plans to post information on requests for exceptions and alternatives on the UDI webpage.
    Because of this your request cannot be considered confidential. If you need to submit company confidential or other protected information to support of your request, please label the confidential information conspicuously and clearly.
  • For CBER regulated devices, send your request:
    By email to cberudirequests@fda.hhs.gov or
    By correspondence to: Office of Communication, Outreach and Development (HFM-40).
    Center for Biologics Evaluation and Research, Food and Drug Administration, 1401
    Rockville Pike, Suite 200N, Rockville, MD 20852-1448