CDRH FY 2019 Proposed Guidance Development and Focused Retrospective Review of Final Guidance

CDRH FY 2019 Proposed Guidance Development and Focused Retrospective Review of Final Guidance

In today’s Federal Register, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced the following lists:

1. guidance documents that we intend to publish this fiscal year (FY2019) (the “A list”);
2. guidance documents that we intend to publish as resources permit (the “B list”); and
3. final guidance documents that issued in 2009, 1999, 1989, and 1979 that are subject to retrospective review.

CDRH updates these lists every year.  The lists reflect our priorities for the upcoming fiscal year and are informed by the work we do today as well as what we anticipate to be the regulatory needs for our work moving forward.

Your feedback is critical in shaping CDRH’s guidance development plans.  We invite you to submit any comments to docket FDA 2012-N-1021.

  

To learn more about the rationale for why CDRH prioritized these guidances for issuance in FY2019, visit the CDRH FY 2019 Proposed Guidance Development and Retrospective Review FDA Voices piece.

   

For additional information, please see:  Federal Register:  Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2019 Proposed Guidance Development.

Center for Devices and Radiological Health
U.S. Food and Drug Administration