Process for COVID-19 Related Guidances

In the Federal Register of March 25, 2020, FDA published a Notice announcing the process for making COVID-19 related guidance documents available to the public. The process is in accordance with FDA’s established good guidance practices regulations and will enable FDA to more rapidly disseminate and implement agency recommendations and policies related to COVID-19.

As part of this process, FDA intends to periodically publish a consolidated Notice of Availability (NOA) announcing the availability of all COVID-19-related guidance documents FDA issued during the relevant period. Interested parties can access the NOAs when published in the Federal Register by clicking on the appropriate link contained in the table below listing COVID-19-related guidance documents.

Implementation of COVID-19 Related Guidance Documents

In accordance with FDA’s good guidance practices, FDA will not seek public comment prior to implementing a guidance document if the agency determines that prior public participation is not feasible or appropriate. Guidance documents where prior public participation is not feasible or appropriate are implemented immediately, but remain subject to comment. Although FDA anticipates that it will immediately implement COVID-19 related guidances, FDA will consider all comments received on any guidances and revise the guidance documents when appropriate.

About FDA Guidances

Guidance documents represent the agency's current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. For information on a specific guidance document, please contact the originating office.