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GUIDANCE DOCUMENT

Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Draft Guidance for Industry and Food and Drug Administration Staff December 2021

Download the Draft Guidance Document Read the Federal Register Notice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Not for implementation.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This guidance is being distributed for comment purposes only.

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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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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-1149

Docket Number:
FDA-2021-D-1149
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 period proposed for advance notice of termination of each EUA declaration pertaining to devices would sufficiently allow for an appropriate transition period that avoids exacerbating product shortages and supply chain disruptions.  
  2. Whether FDA’s issuance of this guidance with a proposed transition policy and requesting public comment may help the Agency to satisfy, or otherwise determine how to best satisfy, while also effectively managing Agency resources, the requirement in section 564(b)(2)(B) of the FD&C Act to consult with a manufacturer that was issued an EUA for an unapproved product on the appropriate disposition of the product. 

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FDA is issuing this draft guidance to provide its recommendations and expectations to manufacturers of devices that were issued EUAs to transition back to normal operations when the emergency use declarations that allowed for FDA to issue EUAs are no longer in effect. 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.

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