NCHR’s Comments to FDA on the Remanufacturing of Medical Devices

September 22, 2021

We are writing to express our views on the Food and Drug Administration’s (FDA) draft guidance for Industry and FDA staff regarding the remanufacturing of medical devices. 

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

We agree with the FDA that clarification is needed of whether or not activities performed on medical devices are considered “remanufacturing” or “servicing,” and we support the draft guidance’s clarity on how to correctly classify a procedure. This is of particular importance, as a correct distinction has important implications for regulation and of how data are reported. We do not have access to the data to determine whether improper classification has resulted in adverse events and deaths inaccurately reported as due to servicing when they are actually due to remanufacturing. However, we agree that clarification of these categories has the potential to help clarify data on the safety of devices.