Per the notice below, the United States Food and Drug Administration (FDA) has issued its list of proposed 2025 guidance documents.
CDRH’s List of Guidance Documents Proposed for Fiscal Year 2025Today, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) identified guidance document priorities in the A-list and B-list for fiscal year 2025 (FY 2025). In addition, CDRH identified final guidances that will be retrospectively reviewed during FY 2025. This year, CDRH is also providing a new list, Under Construction, which is intended to further promote transparency on CDRH guidance development plans. CDRH has posted four lists:
- The A-list: Guidance documents CDRH has prioritized to publish in FY 2025.
- The B-list: Guidance documents CDRH intends to publish in FY 2025 as resources permit.
- “Under Construction” list: Guidance documents that CDRH intends to develop as resources permit that are not on the A- or B-list.
- Retrospective Review list: Final guidance documents issued in 1985, 1995, 2005, and 2015 that CDRH commits to reviewing to ensure that they continue to represent the Agency’s current thinking.
Submit Comments
Your feedback is critical in shaping CDRH’s guidance development plans. Submit comments on any of the guidance document topics at www.Regulations.gov under docket number FDA-2012-N-1021.
Questions?If you have questions about CDRH’s guidance lists for Fiscal Year 2025, contact the CDRH Guidance Program. |
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