Two influential U.S. Senate members have united with the Medical Imaging & Technology Alliance in a bid to better clarify the difference between servicing and remanufacturing.
Sens. Elizabeth Warren (D-MA) and Bill Cassidy (R-LA), MD, sent a letter to the head of the FDA earlier this month, asking for further details on the controversial topic. They have concerns that those who simply service medical devices are not regulated as stringently as remanufacturers. To clear up some of that confusion and ensure patient safety, the Food and Drug Administration plans to publish further guidance on the topic.
"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,” Warren and Cassidy wrote. "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 also posed several questions to the FDA’s acting commissioner, demanding answers by Nov. 1.
“We applaud Senators Warren and Cassidy’s attention to this very important issue,” Dennis Durmis, chair of MITA’s board and radiology head, Americas Region, for Bayer, said 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.”