Webinar Explains Device Remanufacturing Draft Guidance

A CDRH 7/27 Webinar helped to clarify FDA’s current thinking on the distinction between medical device servicing and remanufacturing as discussed in a recent draft guidance. It also outlined specific cybersecurity challenges and opportunities associated with medical device servicing.

During the Webinar staff from the CDRH Office of Product Evaluation and Quality said the remanufacturing draft guidance is not intended to adopt significant policy changes but rather to clarify the agency’s current thinking on applicable definitions and clarify, but not change, the regulatory requirements applicable to remanufacturers.

Staff also said cybersecurity is a widespread issue affecting medical devices connected to the Internet, networks, and other devices. They said an FDA Report on Device Servicing committed the agency to strengthen cybersecurity practices associated with servicing medical devices.