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New Report Faults the Way the FDA Approves Medical Devices

In a report released Thursday, the Government Accountability Office ("GAO") recommended that the FDA fulfill promises it made 14 years ago to fix its system for approving complex medical devices. The report was mandated by Congress in legislation passed in 2007 to reform the FDA.

Most medical devices are given quick approvals with minimal testing because manufacturers tell the FDA that the products operate just like older, already-approved devices.  The GAO report recommends that complex and potentially risky medical devices be thoroughly tested before they are approved for widespread use.