The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) released the list of priority guidance documents that it intends to publish this fiscal year (FY2021).
In addition, CDRH commits to reviewing previously published final guidance documents and updating or deleting guidance documents that no longer represent the FDA’s current thinking on a regulatory issue. CDRH has also committed to finalizing, withdrawing, re-opening the comment period, or re-issuing a revised draft guidance on the topic for 80 percent of draft guidance documents within three years of the close of the comment period, and within five years for the remaining 20 percent, as resources permit.
The FDA has posted three lists including:
· 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.
