News about GMP/cGMP

05.10.2018

CDRH publishes proposed Medical Device Guidance Development 2019

On 3 October 2018, the US FDA’s Center for Devices and Radiological Health (CDRH) has published three lists of guidance documents that may be published in 2019:

 

  • Prioritized medical device guidance documents that the Agency intends to publish in FY 2019 ("A-list")
  • Device guidance documents that the Agency intends to publish, as the Agency's guidance-development resources permit, in FY 2019 ("B-list")
  • Previously-issued final guidances for which CDRH is interested in receiving feedback whether these final guidances should be revised or withdrawn (retrospective review list).
    This list includes documents which were  issued in 1989, in 1999 and in 2009.

 

CDRH calls for comments on any or all of the guidance documents on the three lists, specifically, on the relative priority of guidance documents. Comments should also include suggestions on the draft language on the proposed A-list and B-list topics and suggestions for new or different guidance documents. Those comments should include a statement of reasons. For the retrospective review list CDRH is seeking suggestions regarding which final guidances should be revised or withdrawn.


Source:

CDRH: Fiscal Year 2019 (FY 2019) Proposed Guidance Development

 



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