WHAT: Guidance documents that CDRH intends to publish in FY2017 & previously-issued final guidances for which CDRH is interested in receiving external feedback regarding whether these final guidances should be revised or withdrawn.
WHY: Per MDUFA III negotiations, to help get safe and effective medical devices to market more quickly
HOW: 3 lists
- A List: To be published
- B List: To be published as resources permit
- Retrospective review of 2007, 1997, 1987, 1977 documents