www.fdanews.com/articles/188694-cdrh-issues-guidance-wish-lists-for-next-fiscal-year
![](https://www.fdanews.com/ext/resources/test/Device_Images6/CDRH_Logo.png?t=1506988303&width=430)
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.