FDA Extends Deadline for Servicing, Remanufacturing Comments


Posted January 24, 2019

The Food and Drug Administration (FDA) has extended the deadline for original equipment manufacturers (OEMs), independent service organizations, and healthcare technology management professionals to weigh in on the agency’s continuing effort to address the longstanding debate surrounding medical device servicing.

The extension gives stakeholders an additional 30 days to comment on the FDA’s December public workshop and its related white paper, Evaluating Whether Activities Are Servicing or Remanufacturing. Comments will be used by the FDA to inform future guidance on the topic.

According to the white paper, which describes the FDA’s “initial thoughts about guiding principles,” the FDA defines servicing as “the repair and/or preventative or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications established by the OEM and to meet its original intended use,” while remanufacturing constitutes “processing, conditioning, renovating, repackaging, restoring, or any other act done to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use.”

During the December workshop, Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said that medical device servicers “play a critical role” in ensuring devices remain high quality, safe, and effective but that “there are differing perspectives about what, if any, steps should be taken to ensure or continue to ensure high-quality servicing.”

“Regardless, I think we can all appreciate that technology and our ecosystem continually change and, even in the absence of overt problems, we must continue to evolve,” Shuren said.

Comments can now be submitted to the FDA until Feb. 25. The white paper and videos of the workshop are available for review on the FDA’s website.