The US Food and Drug Administration (FDA) has published its final guidance on the remanufacturing of medical devices, adding a new section on regulatory requirements that clarifies remanufacturers are subject to investigations and inspections by the agency.
“Today’s action represents an important step forward in our mission to assure continued patient access to high-quality, safe and effective medical devices,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, stated in an agency news release. “This guidance provides important clarity on defining remanufacturing and helps to remove perceived barriers to obtaining repair or maintenance of a device if it does not alter the safety, performance or intended use.”…
