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 devices, according to the document. AMDR offers this clarification to help readers draw the distinction between FDA-regulated, commercially reprocessed single-use devices (rSUDs) and reusable, remanufactured devices.
FDA-regulated commercially reprocessed single-use devices reduce cost, waste, and greenhouse gas emissions while strengthening the supply chain. A growing body of peer reviewed life cycle assessments finds that rSUDs reduce greenhouse gas emissions by 41% on average compared to using virgin devices each time.
rSUDs are fully regulated by FDA and thus reprocessors must meet all medical device manufacturing requirements, including pre-market review. The FDA began regulating single-use device reprocessing in 2000, and additional stringent cleaning, testing and performance testing requirements were amended in 2002 as part of the Medical Device User Fee Modernization Act. With one exception, every hospital system in the United States, including 70 U.S. military hospitals, use commercially reprocessed single-use devices. Only the Veterans Affairs Hospitals does not use rSUDs.