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FDA Issues List of Proposed 2023 Guidance Documents

Per the notice below, the United States Food and Drug Administration (FDA) has issued its list of proposed guidance documents for 2023.

CDRH’s List of Guidance Documents Proposed for Fiscal Year 2023

Today, the FDA Center for Devices and Radiological Health (CDRH) posted the list of guidance documents it intends to publish in Fiscal Year 2023.  In addition, CDRH commits to reviewing previously published final guidance documents and updating or withdrawing guidance documents that no longer represent the FDA’s current thinking on a regulatory issue.  CDRH commits to finalize, withdraw, re-open the comment period, or re-issue a revised draft guidance for 80 percent of draft guidance documents within 3 years of the close of the comment period, and within 5 years of the close of the comment period for the remaining 20 percent, as resources permit.

CDRH has posted three lists:

  • Guidance documents the FDA intends to publish (the “A-list”).
  • Guidance documents the FDA intends to publish as resources permit (the “B-list”); and
  • Final guidance documents issued in 2013, 2003, 1993, and 1983 that are subject to focused retrospective review and for which we appreciate external feedback.

 Submit Comments

Your feedback is critical in shaping CDRH’s guidance development plans.  CDRH invites you to submit comments on any or all the guidance document topics at www.Regulations.gov under docket number FDA-2012-N-1021.


If you have questions about CDRH’s guidance lists for Fiscal Year 2023, contact the CDRH Guidance Program.