The FDA has issued two documents to help distinguish between remanufacturing and servicing of medical devices.
One is a draft guidance written to clarify the activities that likely constitute the remanufacturing of a device. The other is a discussion paper on cybersecurity and medtech servicing.
The guidance also describes the FDA’s current position on remanufacturing, and to clarify, not change, the regulatory requirements applicable to remanufacturers. It is not intended to adopt significant policy changes, according to the agency. The cybersecurity/servicing paper outlines cybersecurity issues that are unique to the servicing of medical devices.
The agency plans to hold a webinar on July 27 with more information about the guidance and discussion paper.
The draft guidance will be open for public comments here for 60 days at under Docket Number FDA-2018-N-3741. The public can comment on the discussion paper on the same site, under Docket Number FDA-2021-N-0561.
