FDA Announces CDRH’s 2021 List of Priority Guidance Documents

Today, the FDA’s Center for Devices and Radiological Health (CDRH) announced the list of priority guidance documents that we intend to publish this fiscal year (FY2021). In addition, we commit to reviewing previously published final guidance documents and updating or deleting guidance documents that no longer represent the FDA’s current thinking on a regulatory issue. CDRH has also committed to finalize, withdraw, re-open the comment period, or re-issue a revised draft guidance on the topic for 80 percent of draft guidance documents within 3 years of the close of the comment period, and within 5 years for the remaining 20 percent, as resources permit.

Read the List

We have posted three lists:

Guidance documents that the FDA intends to publish (the “A-list”);
Guidance documents that the FDA intends to publish as resources permit (the “B-list”); and
Final guidance documents that issued in in 2011, 2001, 1991, and 1981 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. We invite you to submit comments on any or all of the guidance document topics for 60 days at www.regulations.gov under docket number FDA-2012-N-1021.