The Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA) has published an extensive list of guidance documents that it intends to publish or develop in fiscal year (FY) 2025.
Posted to the FDA’s website in mid-October, the FDA list of guidances is divided into several sub-lists. Its “A-List” identifies priority guidance documents the agency plans to publish during the 2025 FY and includes 11 “Final Guidance Topics” and seven “Draft Guidance Topics.” The FDA’s “B-List” identifies two additional guidances that it will publish, depending on available resources.
The topics on the FDA’s “A-List” of guidance documents include:
- “510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review (revision)”
- “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff”
- “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions”
- “In Vitro Diagnostics: Labeling”
The complete list of the FDA’s planned guidance documents for FY 2025 is available at the FDA website at https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2025-fy2025.
