Report: Medical Devices Lack Evidence of Safety and Effectiveness

July 29, 2011

FDA Should Scrap Current Fast-Track Approval Process

The prestigious Institute of Medicine (IOM) recently released a report on the Food and Drug Administration’s 510(k) medical device clearance process, which is the short-cut used to review more than 90% of all medical devices.

Medical Devices and the Public’s Health, released in late July 2011, concludes that:

  • “The current 510(k) process is flawed” and should be scrapped. The FDA needs to develop a new system “that provides a reasonable assurance of safety and effectiveness.”
  • Information that the 510(k) clearance process promotes or hinders innovation “does not exist.”

In 2010, an FDA task force recommended numerous changes to strengthen the 510(k) process, but device companies strongly opposed the changes and enlisted the opposition of numerous Members of Congress.  As a result, the FDA delayed implementing the changes intended to protect the public health, with officials explaining that they would wait until the IOM reported on their findings.  Agency officials did not expect the IOM to come out so strongly against the current system.

The IOM report points out that the 510(k) process can’t ensure that devices are safe or effective because it bases FDA approval on a new device’s similarities to devices that are already on the market.  The IOM report determined that the system needs to require evidence of safety and effectiveness in order to protect the public health.  The report recommended that rather than spend scarce resources trying to improve the 5010(k) system, the FDA needs to create a new system that focuses on safety and effectiveness, although it can differ from the Premarket Approval (PMA) standards that are used for the highest risk devices.

“Too many patients have been injured or killed by medical devices cleared through this very flawed short-cut known as the 510(k) process,” said Dr. Diana Zuckerman, president of the National Research Center for Women & Families and the Cancer Prevention and Treatment Fund.  “Patients have been harmed by millions of devices, including defective hips, heart devices, diagnostic tests, and implanted mesh products that haven’t been tested on people. All devices that are implanted and life-sustaining should be held to a much higher standard.”  Dr. Zuckerman has advocated for stronger medical device safety regulations for years, testifying about this in the House of Representatives in 2006 and at a Senate hearing in 2011.

The IOM report is a major setback to the powerful medical device industry, which has spent a king’s ransom lobbying Senators and Congressmen to weaken medical device clearance regulations under the guise of promoting device innovation.

The report echoes the National Research Center for Women & Families’ concerns about the lack of evidence that these devices actually work and are safe. We found that millions of unsafe medical devices are recalled every year that were originally cleared through the 510(k) process.  See our study in the prestigious peer-reviewed journal, Archives of Internal Medicine,”Medical Device Recalls and the FDA Approval Process.”

NRC for Women & Families urges the FDA to immediately strengthen the device approval process by incorporating safety and efficacy standards into the current 510(k) review.  And it calls on the Congress to prioritize public health safety over industry demands to support the status quo.