HELP Hearing on Medical DevicesHELP Hearing on Medical Devices

The purpose of the hearing, according to the opening statement by Senator Mike Enzi (R-WY), was "to evaluate the performance of FDA's device center." Witnesses included CDRH director Jeffrey Schuren and Gregory Curfman, MD, executive editor of the New England Joural of Medicine.

You can watch a video of the proceedings on the committee's Web site.

Earlier in the day, the Safe Patient Project of the Consumers Union, a nonprofit organization advocating for consumers, sent a letter to members of Congress urging them to "use the opportunity provided by the upcoming reauthorization of the Medical Device User Fee Act...to improve the quality, safety and effectiveness of medical devices."

The group recommends that Congress raise approval standards for devices, ensure implantable and life-sustaining devices go through the PMA process, remove recalled devices from the list of predicates, require FDA to implement a system to notify patients of problems with their devices, ensure FDA has adequate resources to implement existing patient protection programs, and enable FDA to issue recalls more effectively.

—Jamie Hartford

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