Medical device makers complain of a regulatory obstacle course at the U. S. Food and Drug Administration, which delays them from getting their new products to market. In turn, some consumer advocates, policy makers and physicians — most notably a recent panel from the Institute of Medicine — contend that the current system does not provide adequate safeguards for patients, let alone test the efficacy of these devices.
The FDA today took a step toward righting the system, issuing for the first time ever draft guidelines on how it will conduct benefit-risk determinations during pre-market review of certain medical devices.
In a release, Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said:
Clinical data is the foundation for determining the safety and effectiveness of medical devices requiring FDA pre-market approval, As medical devices grow increasingly complex, many factors impact our benefit-risk determinations, especially for PMA devices. This guidance aims to provide more clarity to manufacturers about what factors we consider when making an approval decision.
Of course, the devil is in the details, so the agency has posted the guidance proposal on its website and is accepting comments. It remains to be seen whether the medical device industry will see the criteria as a step forward, but they are likely to met with a cool reception by many of the experts on the IOM panel who authored the July 29 report. As was reported in a New York Times editorial, that group “found the current regulatory approach so flawed that it called for it to be scrapped and replaced with a system better designed to protect the public’s health.”
Previously: Comfort from FDA with one question