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American Association for Justice
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FDA 510(k) Device Approval Process Not Protecting Safety of Patients

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This week, the American Association for Justice (AAJ) is publically requesting for a change in the Food and Drug Administration’s (FDA) 510(k) medical device approval process. Essentially, the 510(k) process is used to approve medical devices that are substantially equivalent to medical devices already in the marketplace; however, the 510(k) process does not include post-market surveillance nor does it grant the FDA with the power to repeal clearances if new safety data becomes available.

This process has not been as vigorous and robust as necessary to protect the safety and health of patients.

Specifically, three areas in the 510(k) process need improvement:

1. Penalties for submitting inaccurate data;

2. More reviewers on each 510(k) submission; and,

3. Strengthened 510(k) post-approval monitoring, which includes allowing for post-market surveillance and rescission.

Currently, the FDA has not finalized regulations that would allow for rescission of a 510(k) clearance, although the agency proposed these regulations in 2001. In the interest of patient safety, the FDA should finalize regulations that would allow for the rescission of a 510(k) in any circumstance where patient safety is jeopardized.

The Government Accountability Office reported last year that the FDA inadequately tested many Class III medical devices. The study found in a recent five-year period, the FDA did only minimal testing before approving 228 high-risk medical devices, instead of going through the agency’s more stringent premarket review process as Congress had intended.

Because of a 2007 U.S. Supreme Court ruling in Riegel v. Medtronic, thousands of patients have no legal recourse when they have been injured by faulty medical devices. Congress has introduced the Medical Device Safety Act (S. 540 / H.R. 1346) to restore the rights of medical device patients to seek remedy in court as Congress had intended when they passed legislation on medical device safety in 1976.

Patient safety should be the first priority when it comes to approving medical devices. Congress must pass the Medical Device Safety Act so consumers have recourse if injured by devices that slip through the regulatory approval process.