USA – CDRH Proposed Guidances for Fiscal Year 2020

The lists on this page include guidance documents that CDRH intends to publish this fiscal year (FY 2020), as well as previously-issued final guidances for which CDRH is interested in receiving external feedback regarding whether these final guidances should be revised or withdrawn.

These lists are:

  • The A-list: A list of prioritized device guidance documents that the Agency intends to publish during FY2020.
  • The B-list: A list of device guidance documents that the Agency intends to publish as resources permit during FY2020.
  • Retrospective review list: A list of final guidance documents issued in 1980, 1990, 2000, and 2010…