U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Draft Guidance for Industry and Food and Drug Administration Staff December 2021

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Submit Comments by

Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2021-D-1118

Docket Number:
FDA-2021-D-1118
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The FDA encourages all stakeholders to comment on the following topics: 

  1. Whether the 180-day transition period before FDA withdraws the guidances identified in List 1 would sufficiently allow for an appropriate transition period that avoids exacerbating product shortages and supply chain disruptions.
  2. Suggestions to add or remove guidance documents to or from List 1 of the draft guidance. 
  3. FDA's proposal to extend the effectiveness of the guidances in List 1 of the draft guidance either for 180 days or, if the Public Health Emergency (PHE) declaration under section 319 of the Public Health Service Act expires before the finalization of this guidance, for at least 225 days.

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this draft guidance to provide its recommendations and expectations to manufacturers of devices that fell within enforcement policies to transition back to normal operations when the public health emergency expires. FDA believes the policy set forth in this guidance may help FDA and other stakeholders transition from COVID-19 operations and processes to normal operations and processes.

Back to Top