Remanufacturing of Medical Devices is on the FDAs A List
Wed Oct 11 2023
Remanufacturing of Medical Devices is on the FDA’s A List of Final Guidance topics for 2024.
These lists for fiscal year 2024 are:
• The A-list: A list of prioritized device guidance documents the FDA intends to publish during FY2024.
• The B-list: A list of device guidance documents the FDA intends to publish as resources permit during FY2024.
• Retrospective review list: A list of final guidance documents issued in 1984, 1994, 2004, and 2014
Today, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) posted the list of guidance documents it intends to publish this fiscal year (FY2024). In addition, CDRH commits to review previously published final guidance documents and update or withdraw guidance documents that no longer represent the FDA’s current thinking on a regulatory issue.
CDRH strives to finalize, withdraw, re-open the comment period, or re-issue a revised draft guidance for 80 percent of draft guidance documents within 3 years of the close of the comment period, and within 5 years of the close of the comment period for the remaining 20 percent, as resources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.
Submit Comments
Your feedback is critical in shaping CDRH’s guidance development plans. CDRH invites you to submit comments on any or all 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 2024, contact the CDRH Guidance Program.