For decades, Class III medical devices that are implanted in humans, such as hip implants, have been approved by the FDA through the 510(k) process. The 510(k) process is the fast-track approval process, which does not require clinical studies or pre-market testing. This process was never intended for Class III medical devices; however, a loophole in the FDA regulations that was never addressed until recently has allowed thousands of implanted medical devices to be approved without clinical testing.
Legal Implications of FDA's Proposed Order Affecting MoM Implants
The Legal Intelligencer
February 12, 2013
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