Issue Date: January 26, 2009
FDA Not Scrutinizing Medical Devices
FDA has approved several Class III medical devices—those that carry the most risk for patients—without requiring manufacturers to supply evidence that the devices are safe and effective, finds a Government Accountability Office report (GAO-09-190). For fiscal 2003–07, FDA cleared 24 types of Class III medical devices through a premarket review process called the 510(k), which is typically used to determine whether a low-risk device is equivalent to one that is already on the market. Generally, Class III medical devices must pass a more stringent premarket approval (PMA) process, but some of them can be cleared by the 510(k) process. The Safe Medical Devices Act of 1990 requires FDA to either reclassify those Class III devices that can enter the market via the 510(k) process to a lower class or require PMAs for them. The GAO report confirms that FDA has not completed that task. The report comes just one week after nine FDA scientists wrote a letter to President Barack Obama's transition team citing concerns that FDA managers have corrupted and distorted the agency's medical device review process.
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