Medical device recalls need stricter approvals according to GAO

According to an article on www.cardiovascularbusiness.com, implantable hip joints, such as the DePuy ASR^TM need stricter policies for FDA approvals.
"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."

Read the rest of the article here.

If you or someone you know has been implanted with a DePuy ASR^TM Hip Replacement System or you have undergone or are scheduled to undergo a revision surgery of the DePuy ASR^TM Hip Replacement, you may be entitled to compensation. For a free consultation, contact Hensley Legal Group, P.C. by clicking here or by calling toll-free 1-888-505-8232