FDA skipping steps in high-risk device approvals, GAO report says

01/16/2009

High-risk medical devices are being whisked through the FDA approval process without the review required them, a new report from the GAO says.

Devices are approved on a tiered system, and high-risk (often implantable) ones, including some types of pacemakers, external defibrillators, hips and knees, are designated Class III. Companies seeking approval of Class III devices are required to submit trials proving their safety and clinical efficacy, a process called a pre-market application. But a rule change allowed companies to bypass the PMA if they could prove their product was “substantially equivalent” to one already on the market, and submit a shorter application called a 510(k).

Though Congress reversed that shortcut in 1990, the GAO found that the FDA continues to approve many high risk devices without the required safety and efficacy review. According to the report, 228 devices were approved in this way between 2003 and 2007.

 
Here’s more from the AP, or you can check out the full report on our website.