Image result for CDRH guidances


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which CDRH is interested in receiving external feedback regarding whether these final guidances should be revised or withdrawn.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



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