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 (HHS) Secretary under the Public Health Service Act, on January 31, 2020, and was subsequently renewed through May 11, 2023.  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 has enabled FDA to more rapidly disseminate and implement agency recommendations and policies related to COVID-19.

As part of this process, FDA periodically published 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.

Note that the table on this page includes only COVID-19-related guidances that are currently in effect. The “date posted” refers to the most recent update for that guidance. 

From 2020 through 2022, FDA issued 84 new guidance documents to provide policies, transparency, and flexibility, as appropriate, to address vital medical products for COVID-19 and the public health issues facing the U.S. during this pandemic.

More information about FDA guidance documents is available on FDA’s guidance website. For information about accessing archived versions of withdrawn or expired guidances, see Archived Guidances below. 

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.

Archived Guidances

FDA publicly archives web material for historical reference purposes. To access archives of this page, including guidances that may have since been withdrawn or expired: 

• March 27, 2020 – May 16, 2021: Archives are available in the Internet Archive WayBack Machine. Select a date from the calendar to view an archived version of the page on that day. 
• May 17, 2021 and later: Archives are available in Pagefreezer. Select a date on the left side of the page to view an archived version of the page on that day. 

For assistance with guidance documents, please contact the center that issued the document. 

Related Links

• Withdrawn Guidances (Biologics)
• Withdrawn Guidance (Drugs)
• Withdrawn Guidance (Medical Devices)
• Withdrawn/Replaced Guidances (Animal and Veterinary) 
• Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)