The FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid coronavirus disease 2019 (COVID-19) response efforts. As a result of the COVID-19 pandemic, a Public Health Emergency (PHE) Declaration was issued by the Health and Human Services Secretary, on January 31, 2020, and has been subsequently renewed.  Additional information on the PHE Declaration is available at Public Health Emergency Declarations.

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 announcing the availability of all COVID-19-related guidance documents FDA issued during the relevant period. When published in the Federal Register, the notices are listed below:.

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. As such, guidance documents where prior public participation is not feasible or appropriate are implemented immediately, but remain subject to comment. Although FDA immediately implemented most COVID-19 related guidances, FDA will consider all comments received on any guidances and revise the guidance documents when appropriate.

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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.