Dive Brief:

• A bipartisan pair of senators is urging FDA to provide details on its forthcoming draft guidance on the difference between medical device servicing and remanufacturing in a new letter to the agency.
• Medical device remanufacturers perform maintenance activities that "significantly change" the safety, performance or intended use of a product, while servicers "provide preventive or routine maintenance" to a used device to return it to the safety standards of its original intended use. In its recently published fiscal year 2020 guidance priority list, the agency placed the development of draft guidance on the subject on its A-List, indicating FDA intends to publish it by next September.
• Sens. Elizabeth Warren, D-Mass., and Bill Cassidy, R-La., write while they are "pleased FDA plans to issue guidance" to clarify the issue, the lack of data on firms that perform medical device servicing may hinder regulatory efforts to oversee the sector. The agency does not require servicers, who face fewer regulatory requirements than remanufacturers, to register ​with the agency, but FDA estimates the number of servicers in the United States to be between 16,520 and 20,830. 

Dive Insight:

The new letter, delivered last Friday to Acting Commissioner Ned Sharpless, is the second time the two senators are asking FDA for more transparency around the issue; in 2018, the two inquired about progress on the completion of a report required by the FDA Reauthorization Act of 2017 on medical device servicing. 

The FDA report, released in May 2018, found "the currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing of medical devices, including by third party servicers, that would justify imposing additional/different burdensome regulatory requirements at this time." 

While the agency declined to take formal regulatory action, it committed to promote the adoption of quality management principles, clarify the difference between servicing and remanufacturing, strengthen medical device cybersecurity efforts, and boost evidence development to access the safety and effectiveness of servicing. 

"A significant portion of the comments, complaints, and adverse event reports alleging inadequate servicing pertain to activities more accurately described as remanufacturing," the FDA report said. "Because of the apparent confusion we have heard from stakeholders concerning the difference between servicing and remanufacturing activities, FDA intends to publish guidance to assist in differentiating these activities to allow more consistent interpretation and categorization."

Warren and Cassidy asked FDA how the agency plans to detect which servicers also engage in remanufacturing and how it intends to educate those that are doing so unknowingly. They also want to know how the agency plans to "promote compliance" with regulations for those entities and which actions FDA will take if it determines a servicer is engaged in remanufacturing. 

The senators asked FDA to respond to the letter by Nov. 1.