FDA announces new guidance documents

The FDA CDRH announced the guidance documents they intend to publish in FY2022. They also announced their intention to finalize, withdraw, re-open the comment period, or re-issue a revised draft guidance for 80 percent of draft guidance documents within 3 years of the close of the comment period, and within 5 years of the close of the comment period for the remaining 20 percent, as resources permit.

There are three lists:

  • Guidance documents they intend to publish (A-List).
  • Guidance documents they intend to publish as resources (B-List).
  • Guidance documents issued in 1982, 1992, 2002, and 2012 intended to be opened for retrospective review.

The lists can be viewed on the FDA website.

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