Healthcare Technology Report May 27, 2024
The U.S. Food and Drug Administration (FDA) has released its final guidance on the remanufacturing of medical devices, providing clarity on regulatory requirements for remanufacturers. The guidance emphasizes the distinction between servicing and remanufacturing, defining later as activities that significantly alter a device’s performance or safety specifications beyond its original intended use. Remanufacturers are now subject to investigations and inspections by the FDA, ensuring compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations.
FDA Director Jeff Shuren stated that the guidance aims to maintain patient access to...
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