The IOM released a report last week reviewing the 510(k) medical device approval process. The report finds that the current FDA process “lacks the legal basis to be a reliable premarket screen of the safety and effectiveness” of devices. The panel producing the report recommends that rather than build on this flawed system, the FDA needs a framework that integrates premarket reviews and post-market oversight of these devices. These recommendations deserve strong consideration by Congress as it takes up the Medical Devices User Fee Act (MDUFA) reauthorization in 2012.

This current process (referred to by the numbered section of the law establishing it) allows faster approval for devices that are similar to those that FDA has already approved and are on the market. Extensive FDA pre-market review of the device is not required for these devices. This 510(k) review, used for about 90 percent of medical device applications subject to premarket review, takes about 10 months as opposed to the years that a more complex review would take.

However, the medical device industry has exploded since the original law was passed to regulate this process 35 years ago. The FDA received about 4,000 510(k) submissions in 2009 (IOM). After so many years and so many devices, it is an important time to review devices for their safety. An example of a high profile massive recall was Johnson & Johnson’s artificial hip in August 2010 and 93,000 patients worldwide had that implant. The device was approved using the 510(k) process. Unlike drugs, where people can stop taking them if they experience adverse reactions, an implanted medical device has to be surgically removed and requires a lot more medical intervention and potential harm to patients if the device fails. Omitted from the law creating the 510(k) review process is reviewing if the product is safe and effective. Instead, the FDA only has to determine if it’s reasonably similar to another product on the market before it can be let loose on the public.

This year, in anticipation of the upcoming debate on MDUFA, the industry has been doing some heavy lobbying of Congress for limited regulation of the medical devices. They went so far as to try to discredit this IOM report before it was even released. Senators from states where large medical device manufacturers are incorporated have said that more stringent regulation of these devices will stifle innovation which is a stretch given the conclusions of this report. However, the report indicates that “the FDA should not be the arbitrator of what constitutes innovation” and there was no way to determine whether this process has helped or hindered innovation. While consumers may be interested in devices that create new solutions to health problems, they expect these devices to be fully vetted for safety and effectiveness – even if when approved on a fast track.

As it stands now, the FDA through this 510(k) process, has no way to determine that a device is safe and effective. Congress would have to pass legislation to give the FDA more power to ensure that these devices are safe and effective before they hit the market. This can be done next year during the MDUFA debate.

The FDA will accept public comments on the IOM’s recommendations. The FDA will have a public meeting in the coming weeks to discuss the recommendations made in the report. We will be following this issue closely and keep you posted on how you can voice your concerns about medical device safety.

August 5, 2011 UPDATE: According to Politico: “Bill Maisel, deputy director for science at the FDA’s Center for Devices and Radiological Health, said the agency is accepting public comment on the report and will issue its formal reaction by the end of October at the latest.”