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