The Food and Drug Administration (FDA) has extended the May 3 deadline for its recent inquiry into the “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices performed by Third-party entities and Original Equipment Manufacturers” by another 30 days. Stakeholders can now submit feedback through June 3.
According to an announcement published in the Federal Register, the FDA “is taking this action due to the unanticipated high-level of interest from interested persons.” The agency said it received multiple requests from stakeholders for a 30-day extension to “develop [a] meaningful or thoughtful response.” The new deadline will provide “adequate time for interested persons to submit comments without significantly delaying future workshop on these important issues,” the FDA says.
Issued on March 4, the original document called on stakeholders in the medical device industry and healthcare community to comment on potential safety issues related to the maintenance, repair, and refurbishment of medical equipment. The inquiry applied to activities conducted by both original equipment manufacturers (OEM) and third parties, including healthcare organizations. The FDA identified several key areas of interest, including specific examples of safety issues resulting from repair, risk associated with various activities, and the information required to ensure safe operation of a medical device.
For guidelines about how to submit comments, visit the Federal Register website.
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