Senators Elizabeth Warren (D-MA) and Bill Cassidy (R-LA) are expecting responses this week to a letter they recently sent the FDA concerning the agency’s upcoming guidance distinguishing servicing from remanufacturing activities for medical devices.

“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,” they wrote. "This assessment raises questions about how the FDA, once it issues its 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 need for distinguishing these terms arose from the FDA's recent investigation into third-party servicing, which concluded in May 2018 and found insufficient evidence to warrant additional regulation of non-OEM servicers. The majority of alleged inadequate servicing incidents they discovered actually pertained to remanufacturing, a more complex activity that calls for compliance with numerous FDA requirements.

Since the report, the agency has issued a white paper for differentiating the two terms and held a number of workshops to discuss the matter with manufacturers, independent service organizations, biomeds and other stakeholders.

Warren and Cassidy posed a series of questions regarding the FDA's plans for differentiating the two activities:

1. In its May 2018 report, the FDA stated that "[a] majority of comments, complaints, and adverse event reports alleging that inadequate "servicing" caused or contributed to clinical adverse events and deaths actually pertain to "remanufacturing" and not "servicing."

• If so many entities believed to be involved in "servicing" are actually "remanufacturing" devices, and FDA has said "the precise number of entities that perform servicing of medical devices in the U.S. is not known," 14 how does FDA intend to identify the universe of actors to whom its upcoming guidance will apply?
• How does the FDA intend to educate those entities who are unknowingly involved in remanufacturing activities about their obligations when the upcoming guidance is released?

2. The FDA has estimated approximately 16,000 to 20,000 entities are engaged in servicing activities. How will the FDA promote compliance with the guidance by those entities who consider themselves as only servicers, but who may in fact also be involved in remanufacturing?
3. What surveillance mechanisms are available to the FDA to detect servicers who are also performing remanufacturing?
4. What actions does the FDA currently take if it identifies unregistered entities engaged in remanufacturing? What, if any, new options for action are under consideration?

“We applaud Senators Warren and Cassidy’s attention to this very important issue,” said Dennis Durmis, SVP, radiology head of Americas region at Bayer and chair of the MITA board of directors, in a statement. “Organizations that are engaged in servicing and remanufacturing are looking to the FDA to make clear the differences between the two activities.”

The FDA plans to address the issue in its 2020 proposed guidance list, which is expected for release next September.

Warren’s office did not respond for comment.