CDRH Releases Expected 2017 Guidance Topics

CDRH has issued lists of guidance documents that it intends to publish in FY 2017 as well as previously-issued final guidances for which it wants to receive external feedback on whether they should be revised or withdrawn.

The Web posting contains three separate lists: (1) an “A-List” of guidance documents the agency fully intends to publish; (2) a “B-List” of guidance documents it intends to publish as resources permit; and (3) a list of final guidance documents issued in 1997, 1987, 1997, and 2007 subject to focused retrospective review.

The Center says it would appreciate comments on any or all of the documents on the three lists, and specifically comments on the relative priority of guidance documents. Comments could also include draft language on the proposed A- and B-List topics or suggestions for new or different guidance documents. For the retrospective review list, CDRH is seeking suggestions about which guidances should be revised or withdrawn.