CDRH Issues Guidance Wish Lists for Next Fiscal Year

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.