FDA issues final guidance on reprocessing medical devices

The US Food and Drug Administration (FDA) has published final guidance on the reprocessing of medical devices, providing clarity on regulatory requirements for reprocessors. The guidelines emphasize the difference between servicing and remanufacturing, later defining activities that significantly alter a device’s performance or safety specifications beyond its original intended use. Regenerative manufacturers are currently 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 said the guidelines are intended to maintain patient access to high-quality, safe and effective medical devices while removing barriers to device repair and maintenance. The agency’s engagement with industry and society since 2016 led to the publication of this guidance, which addresses concerns expressed by stakeholders regarding regulatory oversight, terminology and enforcement. Remanufacturing manufacturers are now required to comply with pre-market requirements, have their own equipment inventory and facility registration, and comply with quality system regulations. The FDA encourages OEMs to provide service manuals that facilitate routine maintenance and repair of reusable devices, promoting public health while respecting trade secrets and confidential information.

read more