October 17, 2019

Senators Warren and Cassidy Request Information from FDA on Upcoming Medical Device Servicing Guidance

The FDA is expected to issue guidance clarifying the distinction between device servicing and remanufacturing

Text of Letter (PDF)

Washington, DC - United States Senators Elizabeth Warren (D-Mass.) and Bill Cassidy (R-La.) sent a letter to U.S. Food and Drug Administration (FDA) Acting Commissioner Norman Sharpless, M.D., requesting information about the FDA's upcoming guidance clarifying the distinction between remanufacturers and servicers.

Once FDA-approved medical devices enter the market, equipment manufacturers and third-party entities often perform maintenance on them to ensure that they continue to operate safely and effectively. Entities that perform maintenance activities face different regulatory requirements depending on the type of maintenance being performed. Activities that "significantly change" the performance, safety specifications, or intended use of an approved device are considered "remanufacturing." Remanufacturers must comply with numerous FDA requirements. Activities that do not significantly change the performance, safety specifications, or intended use of a device-but instead provide "preventive or routine maintenance" for the purpose of returning a device to original safety and performance specifications-are considered "servicing." The FDA does not hold servicers to the same safety and reporting requirements as remanufacturers.

According to the FDA, there is significant uncertainty among the medical device industry about what constitutes servicing versus what constitutes remanufacturing. As a result, the FDA announced that it would publish guidance clarifying the difference between "servicing" and "remanufacturing." 

"We applaud the agency's commitment to clarifying the distinction between servicing and remanufacturing, particularly in light of significant discussion within the medical device industry about the difference between the two activities," wrote the senators. "This ... raises questions about how the FDA, once it issues final guidance, will clarify, communicate, and enforce the distinction between 'servicing' and 'remanufacturing' to entities that believe themselves to be 'servicers,' but who may in fact be 'remanufacturers' subject to more stringent regulation."

The senators have requested responses to their questions to better understand the FDA's consideration of this matter and how it plans to address these issues in its forthcoming guidance by November 1, 2019.

Last Congress, Senators Warren and Cassidy sent a letter to the FDA expressing interest in the release of an FDA report on medical device servicing.