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March 10, 2023 update: HHS has announced that, based on current COVID-19 trends, the Department is planning for the COVID-19 public health emergency (PHE) declared under the Public Health Service (PHS) Act to expire on May 11, 2023.
In the Federal Register of March 13, 2023, FDA will publish a notice addressing the Agency’s COVID-19-related guidance documents, including which of those guidance documents will no longer be in effect after the expiration of the PHE, and which of those guidance documents FDA is revising to temporarily continue in effect.
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.
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.