The Medical Imaging & Technology Alliance (MITA) expressed support for H.R. 7253, The Clarifying Remanufacturing to Protect Patient Safety Act, to clarify the meaning of remanufacturing as it relates to medical devices to better protect patients by helping educate stakeholders about remanufacturing activities, which fall under U.S. FDA oversight.

MITA is a trade association that represents manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices.

“We appreciate Members of Congress taking up this technical legislative fix to provide clarity as to what does and does not constitute remanufacturing, and thus is subject to FDA oversight,” says Patrick Hope, executive director of MITA. “The current definition of remanufacturing is vague and requires updating, which this legislation would fix. This bill would also help enhance patient safety and device performance while also helping to mitigate cybersecurity concerns.”

H.R. 7253 would define remanufacturing in statute and clarify the activities that require registration, reporting, and oversight. The bill also provides for public education and transparency measures to raise awareness of safety concerns and allow responsible actors to come into compliance.

In a 2018 report, the FDA concluded that a majority of adverse medical device events reported to the Agency – including those contributing to deaths – were the result of unregulated remanufacturing.

FDA started a workstream, including recent issuance of a draft guidance, to address the need for clarity in remanufacturing activities. H.R. 7253 would build off FDA’s previous work by bringing greater clarity to remanufacturing regulations and providing necessary oversight of remanufactured medical devices to protect the health and safety of patient and healthcare providers. 

“This is a commonsense solution that deserves the support of any and all in the medical device engineering community. MITA encourages Members of Congress to pass this legislation without delay,” Hope says.