The Medical Device Patient Safety Act

On December 15,  2011, U.S. Senators Chuck Grassley (R-IA), Richard Blumenthal (D-CT) and Herb Kohl (D-WI) introduced “the Medical Device Patient Safety Act” (S. 1995).

The Medical Device Patient Safety Act has two important goals. It improves the Food and Drug Administration’s (FDA) management of recalled devices, and enhances FDA’s post-market surveillance and data collection tools.

• Improved Recall Processes: The bill would implement the Government Accountability Office (GAO) recommendations to improve FDA’s management of medical device recalls. The legislation would require the FDA to assess its recalls, determine whether a recall was implemented effectively and terminate completed recalls.
• Enhance Post-Market Surveillance Tools: This legislation would enhance the FDA’s ability to conduct post-market surveillance for 510(k)-cleared devices by allowing the FDA to require the collection of post-market data as a condition of approval. The authority would mirror the post-market studies that can be required as a condition of a Pre-Market Approval (PMA) for highest risk devices. Under this legislation, the FDA could require conditions of clearance for 510(k)-cleared devices that may have safety concerns. If the FDA found a device substantially equivalent to a predicate for a higher-risk device, the FDA could clear the device for market through 510(k) but  require companies to conduct clinical studies and collect and report more complete data.

The bill was introduced as a placeholder for next year’s discussion on the FDA User Fees. The Senators intend for this reform bill to be included as a section of the Medical Device User Fees Reauthorization Act.