FDA’s remanufacturing draft guidance is at the top of the device center’s guidance agenda for fiscal 2023, indicating the agency could publish the highly-anticipated final version of the document this fiscal year.
The agency’s device center published its annual guidance agenda Oct. 19, placing the remanufacturing guidance at the top of the so-called A-list, which is reserved for “prioritized” guidance documents that FDA intends to publish. The remanufacturing guidance was also on the agency’s “A list” for fiscal 2022, but it was never finalized. The other five draft guidances on the A-list were finalized throughout 2022.
Independent service organizations and original manufacturers have been at odds for years over how or whether third-party medical device servicers should be regulated by FDA. At the crux of the debate is what constitutes servicing of a device and what’s considered remanufacturing.
Click here to see the full article on the Inside Health Policy website.