Home » CDRH Issues Guidance Wish Lists for Next Fiscal Year
CDRH Issues Guidance Wish Lists for Next Fiscal Year
October 5, 2018
The FDA released three lists of guidance documents it will or may issue in the next fiscal year — including an “A-list” of those the agency plans to publish, a “B-list” of guidance it hopes to issue if the resources are available, and a list of existing final guidances that it plans to review.
The agency agreed to post the lists annually during MDUFA III and IV negotiations.
The planned final guidances on the A-list include guidance for sponsors on the humanitarian device exemption, the breakthrough devices program, the Special 510(k) program, and on the agency’s least burdensome regulatory approach.
Upcoming Events
-
21Oct