A report conducted this month by the Government Accountability Office (GAO) found that the FDA may need a more stringent process for device approval, particularly for high-risk devices such as automated external defibrillators (AEDs) and implantable hip joints.
In 2009, the GAO recommended that the FDA take steps to issue regulations for high-risk devices allowed to enter the device market through the agency’s 510(k) process. And while the FDA has since issued a final rule regarding classifications of one device, as of April 1, the FDA had yet to enforce action on 26 Class III devices.
According to GAO, devices such as AEDs are still entering the U.S. device market through a “less stringent” 510(k) process approval. Since the GAO report released in 2009, the FDA has since cleared an estimated 67 510(k) submissions for these types of high-risk devices.
“While FDA has taken essential initial steps toward implementing our recommendation, until the agency issues final regulations either reclassifying or requiring PMAs [pre marketing approvals] for Class III device types that currently can be cleared through the less stringent 510(k) process, its actions remain incomplete,” according to the GAO.
And while the FDA has implemented some additional steps, such as having the Institute of Medicine conduct independent reviews of the premarketing review process, the GAO said the FDA process is still incomplete.
Between 2005 and 2009, device makers issued 3,510 voluntary device recalls; however, work has not been carried out by the FDA to understand the reasons why these devices were recalled or the risks they presented.
“GAO’s preliminary findings indicate that FDA lacks clear guidance for overseeing recalls, which has led to inconsistencies in FDA’s assessments of whether individual recalls were implemented effectively,” the report stated.
Additionally, GAO said that the lack of oversight from the recall process may limit the FDA's ability to recall high-risk devices in a timely manner.
While the GAO deemed FDA’s actions to improve the premarketing approval process as “positive steps,” the office said that “it remains to be seen whether these actions will help ensure that medical devices marketed in the U.S. receive appropriate premarket review.”
The GAO concluded, “While it is important to allow devices on the market to treat patients who need them, it is also essential that FDA take necessary steps to provide a reasonable assurance that those medical devices that do enter the market are safe and effective. Likewise, it is vital that the agency’s postmarket safety efforts are both vigorous and timely.”