As recently as March 30, FDA director for the Center for Devices and Radiological Health, Dr. Jeff Shuren, acknowledged to the Energy & Commerce Health Subcommittee that “clarity about what constitutes and what doesn’t constitute remanufacturing is critically important.” And while the Agency has recognized the need to address this confusion through proposed guidance, this bill only enhances FDA’s continued work on remanufacturing. Furthermore, the legislative branch (Congress) has the ultimate authority to weigh in and oversee executive actions. Additional opportunities for public comment will also likely be available under expected rulemaking or guidance development resulting from this legislation.

Given the substance of this legislation, a clear pathway to its passage should be as a provision in the Medical Device User Fee Agreement (MDUFA), and clarifying the definition of remanufacturing would not be out of line with precedent. Beyond being germane to FDA policy, this would help to prevent serious injury or poor image quality resulting from inadvertent remanufacturing. Errors in device function can have devastating consequences — leading to delayed or missed diagnosis or repeated imaging procedures and increased healthcare costs. It’s clear that the real mistake here would be if Congress lets this opportunity slip by.


Patrick Hope is executive director of the Medical Imaging and Technology Alliance (MITA), representing the collective voice of manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices.

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