On June 24, 2021, the Food and Drug Administration (FDA) issued the long-awaited
Remanufacturing of Medical Devices Draft Guidance (Draft Remanufacturing Guidance), which describes the agency’s current thinking on activities that meet the definition of remanufacturing and a process for determining whether an act done to an original equipment manufacturer’s (OEM’s) legally marketed finished device is considered remanufacturing.
The Draft Remanufacturing Guidance is the culmination of a process that began in 2016, when FDA opened a docket for public comment and held a public workshop to solicit opinions on quality, safety, and continued effectiveness of medical devices that have been subject to refurbishing, reconditioning, rebuilding, remarketing, remanufacturing, and servicing. Subsequently, the Food and Drug Administration Reauthorization Act of 2017 (FDARA) required FDA to publish a report on the continued quality, safety, and effectiveness of medical devices with respect to servicing, which led to FDA’s May 15, 2018 Report to Congress. The report concluded that “a majority of the comments, complaints, and adverse event reports received by [FDA] that referred to inadequate ‘servicing’ causing or contributing to adverse events and deaths actually pertained to ‘remanufacturing.’” FDA then issued a white paper and held a public workshop in December 2018 to obtain input on the differences between “remanufacturing” and “servicing.”