The Food and Drug Administration published a Proposed Rule in the Federal Register establishing a docket and requesting information and comments on third party entities that “refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices.” This request comes after stakeholders expressed quality and safety concerns for medical devices subject to those activities. Particularly, stakeholders expressed concerns about the use of unqualified personnel in performing the relevant activities and inadequate documentation of work performed. The FDA found that these activities could lead to public health issues including “ineffective recalls, disabled safety features, and improper or unexpected device operation.” In addition to comments regarding “service, maintenance, refurbishment, and alteration of medical devices by third party entities”, the FDA is also seeking comments on the challenges faced by third-party entities in “maintaining and restoring medical devices to their original or current specifications.” The comment period for the Proposed Rule ends on May 3, 2016.
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FDA Asks for Comments on Refurbishing and Servicing of Medical Devices
Brian Flynn focuses on patent preparation and litigation. He counsels clients in a wide variety of technologies, including: · Medical Device: medical and dental instruments, implants, diagnostic equipment, and communication and data systems · Mechanical: automotive technology, sporting goods, kitchen appliances, beverage containers, and toys · Electronics: digital camera technology, mobile devices, GPS devices, and sensor technology Brian received his law degree from the University of Illinois College of Law, where he served as the Secretary for the Intellectual Property Legal Society and as an Articles Editor for the Journal of Law, Technology & Policy. Prior to his legal education, he received a Bachelor's Degree in Bioengineering from the University of Illinois.Click here to read full bio View all posts published by Brian Flynn »
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