AMDR Statement: FDA’s Recently Published Guidance Document, “Remanufacturing of Medical Devices,” Addresses Reusable Devices, not Reprocessed Single-Use Devices
On May 10th, 2024, the U.S. Food and Drug Administration issued final guidance titled, “Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff.” AMDR wishes to highlight that the guidance “is not intended to address reprocessed single-use devices” and instead addresses the remanufacturing of reusable