May 07, 2018

Warren, Cassidy Express Interest in Timely Completion of FDA Report on Medical Device Servicing

Text of letter (PDF)

Washington, DC - United States Senators Elizabeth Warren (D-Mass.) and Bill Cassidy (R-La.) today sent a letter to the Food and Drug Administration (FDA) about the regulation of entities that repair, refurbish, recondition, and remanufacture medical devices. The senators expressed interest in the timely completion of the FDA's forthcoming report on medical device servicing. The FDA Reauthorization Act of 2017 requires the FDA to post a public report that provides an overview of its statutory and regulatory authority related to the regulation of medical device servicers, as well as information on the agency's current efforts to track and prevent adverse events stemming from medical device servicing.

"Medical devices help people live longer, healthier lives, and Massachusetts has some of the most innovative device companies in the world," said Senator Warren. "Senator Cassidy and I look forward to working with the FDA to ensure medical devices are safe to use."

"The FDA is doing good work to ensure patient safety with respect to medical devices, and I look forward to reviewing their upcoming study," said Dr. Cassidy.

The senators noted their appreciation for the FDA's continued attention to this critical patient safety issue and hope to continue working with the FDA on initiatives to protect public health.