Reconditioned Devices: Potential Regulatory Changes Create Tension Between Third-Party Entities, OEMs
‘Reconditioned Devices’ is part of a MED DEVICE ONLINE guest expert series by Halloran.
In recent days, there’s been an uptick in the conversation surrounding the reconditioned medical device market. Much of the buzz concerns changes to quality system regulation (QSR) for third-party entities and original equipment manufacturers (OEMs) operating in the refurbished equipment market. These manufacturers have largely been exempt from existing QSR requirements under CFR part 820, due to a 1998 decision by FDA to exclude refurbishers and servicers. The 1998 decision came after a thorough evaluation of the regulation of device servicing, refurbishing, and remarketing; so why is this rule reemerging?
First, in March of 2016, the FDA released a request for comments regarding its draft rule entitled Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers. This rule is an attempt by FDA to address concerns over quality, continued effectiveness, and patient safety. Bringing attention to a dormant subject, the FDA noted that “possible public health issues arising from these activities include ineffective recalls, disabled device safety features, and improper or unexpected device operation.” If these “possible issues” are found to be actual issues, FDA may decide to strengthen regulatory requirements, bringing major changes to the refurbished medical device market.
The second element bringing attention to this subject is a report released this fall by Technavio, which predicts the global market for refurbished medical devices will reach $11.9 billion by 2021, driven mainly by advancements in new medical equipment technology, such as diagnostic medical imaging equipment, and increased demand for affordable equipment, especially in developing countries. In such a huge market with growth on the horizon, both OEMs and third-party entities are jostling for position. In this arena, any changes to regulatory requirements could make or break some companies, so competitors in the space need to remain nimble, ready to make any necessary changes resultant from a regulatory overhaul.
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