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GUIDANCE DOCUMENT

Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff March 2023

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2021-D-1118
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19). FDA is committed to providing timely guidance to support response efforts to the COVID-19 pandemic. FDA is issuing this guidance to provide its recommendations and expectations to manufacturers of devices that fall within certain enforcement policies issued during the COVID-19 public health emergency to transition to normal operations when the public health emergency declaration related to COVID-19 under section 319 of the Public Health Service Act ends. FDA believes the policy set forth in this guidance will help FDA and other stakeholders transition to normal operations and processes. 

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

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