Hundreds of high-risk medical devices have been approved by the Food and Drug Administration using a less-stringent, pre-market approval processa move that run counters to congressional intent, according to a new report released by the Government Accountability Office.
The GAO found that in fiscal years 2003 through 2007, the FDA gave the OK for 24 types of Class III devices through the less stringent 510(k) process, with at least 20 more that could follow suit. The FDA said that it is in the process of issuing regulations that would clear up the process.
GAOs investigation confirms my concerns that the approval process for medical devices is woefully inadequate, Rep. Frank Pallone Jr. (D-N.J.), chairman of the House Energy and Commerce Health Subcommittee, said in a written statement. For years, Congress has required high-risk medical devices to undergo stringent pre-market review, but GAOs findings show that is simply not happening in every case.
Pallone said that he would further investigate the GAOs findings and could introduce legislation to force the FDAs hand.
Federal regulations put medical devices into three different categories, with Class III having the greatest risks to patients. Unless exempt, new devices must clear FDA pre-market review by either the 510(k) process, which determines if a new device is equivalent to another legally marketed device, or the pre-market approval process, which requires the manufacturer to supply evidence that the device is safe and effective.