News about GMP/cGMP

29.10.2021

FDA/CDRH: Proposed Guidances for FY 2022

FDA/CDRH: Proposed Guidances for FY 2022

The FDA’s Center for Devices and Radiological Health (CDRH) has published its lists with guidance documents intended to be published next year. At this stage CDRH is interested in receiving external feedback on whether the listed documents should be revised or withdrawn.


The documents have been split into three lists:

  • The A-list, for prioritized device guidance documents the FDA intends to publish during the fiscal year 2022
  • The B-list, for device guidance documents the FDA intends to publish as resources permit during the fiscal year 2022
  • A retrospective review list with final guidance documents issued in 1982, 1992, 2002, and 2012, with an option for withdrawl

Electronic comments can be submitted to www.regulations.gov.


Source:

FDA/CDRH: Proposed Guidelines for FY 2022


 

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