AAJ: FDA 510(k) Device Approval Process Not Protecting Health and Safety of Patients

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For Immediate Release: March 18, 2010

Contact: Jennifer Fuson
202-965-3500, ext. 8369

AAJ: FDA 510(k) Device Approval Process Not Protecting Health and Safety of Patients

FDA should require post-market surveillance, have power to repeal 510(k) medical device approvals

Washington, DC—The Food and Drug Administration (FDA) should require post-market surveillance of 510(k) medical devices and have the power to repeal clearances if new safety data becomes available, according to comments submitted today by the American Association for Justice (AAJ).  The comments are in response to the FDA’s on-going efforts to strengthen the medical device approval process.

The 510(k) process is used to approve medical devices that are substantially equivalent to medical devices already in the marketplace.  In its submitted comments, AAJ states that “this process has not been as vigorous and robust as necessary to protect the safety and health of patients.”

The 510(k) areas needing improvement include:

  • Penalties for submitting inaccurate data;
  • More reviewers on each 510(k) submission; and,
  • 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,” AAJ says in their comments.

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,” said AAJ President Anthony Tarricone.  “Congress must pass the Medical Device Safety Act so consumers have recourse if injured by devices that slip through the regulatory approval process.”

To see a copy of the comments, click here.

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