The failure of the Food and Drug Administration to take stronger action in both premarket and postmarket oversight of Class III medical devices--which includes pacemakers and replacement heart valves--is raising serious concerns about the organization's regulation of those devices, according to a new report from the Government Accountability Office (GAO).
On the premarket side, Marcia Cross, GAO's director of health care, told the House Energy and Commerce Health Subcommittee last week that FDA was not reviewing all class III devices through its most stringent premarket review process. Unless an exemption is made by regulation, all new devices must clear FDA premarket review using either the 510(k) premarket notification process, which is used to determine if a new device is equivalent to another legally marketed device, or through the more stringent premarket approval (PMA) process, which requires manufacturers to supply evidence showing "reasonable assurance" that the device is safe and effective.
In 1976, GAO said that Congress envisioned the FDA would eventually approve all class III devices through the more stringent PMA process; however, GAO investigators said this process was incomplete. The investigators found that in fiscal 2003 through 2007, FDA cleared 228 submissions representing 24 types of class III devices through the 510(k) process.
GAO recommended in a January 2009 report that the FDA take steps to issue regulations requiring PMAs—or reclassify class III device types currently allowed to enter the market via the 510(k) process. In response, in April, FDA required manufacturers to submit information on the safety and effectiveness of these types of devices. However, FDA did not specify a timeframe for how quickly it will reclassify them or require PMAs for those devices in class III.
In the postmarket phase, GAO said FDA also faces challenges as well. In 2008, GAO reported that the number of adverse event reports associated with medical devices increased substantially from 2000 to 2006. Both GAO and FDA, however, have identified shortcomings in FDA's postmarket oversight. For example, in 2006 FDA reported that while they have a number of strategies to prioritize their reviews of adverse event reports, they still cannot review all the reports they receive.
William Maisel, MD, director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston, told the panel that in light of high-profile device safety issues and FDA's ability to monitor the safety and effectiveness of these devices, additional consumer safeguards are needed.