Legislation Is Proposed to Require Postmarket Studies of Devices That Receive 510(k) Approval

December 15, 2011—US Senators Chuck Grassley (R-Iowa), Richard Blumenthal (D-Connecticut), and Herb Kohl (D-Wisconsin) announced the introduction of legislation that seeks to protect patients from unsafe medical devices and improve the management of recalls.

The Medical Device Patient Safety Act would give the US Food and Drug Administration (FDA) important tools to discover problems with faulty medical devices sooner and to better manage recalls when problems do occur, without slowing down the approval process for new devices. A summary of the proposed act is available on Senator Grassley's Web site.

The legislation would allow the FDA to require postmarket clinical studies for medical devices that pose potential safety risks, if they were approved through the expedited 510(k) review process. The bill also would implement Government Accountability Office (GAO) recommendations for improving recalls and give the FDA new authority to require conditional clearance pending safety studies for devices reviewed under the fast-track 510(k) approval process. The GAO report was issued in June 2011 and can be downloaded at GAO Web site.

“This reform legislation should be part of the reauthorization of the medical device user fee law next year,” Senator Grassley said. “The reforms incorporate well-founded recommendations from the Government Accountability Office and reflect the value of having a robust postmarket surveillance operation in the FDA. Important information can be learned about product safety after a device is on the market, and when there are problems, the sooner the response, the better.”

Senator Blumenthal added, “Unsafe medical devices pose severe dangers to patients and impede approval of new, safe devices, causing significant costs to our economy as well as health. This bill will help protect people from dangerous unsafe medical devices by demanding more consumer safeguards, improving recall management, avoiding costly recalls, and preventing irreversible injury to patients. By removing unsafe devices from the market more quickly and efficiently, we're preserving a faster approval track for safe and effective products to reach patients.”

According to Senator Kohl, “Faulty medical devices, especially those implanted in the body, can have disastrous health impacts on patients. This legislation will help ensure that FDA can act quickly and decisively when there's a problem, and that the drive toward getting new technologies to market won't come at the risk of patient safety.”