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Health Insurers Call for Stronger Rules on Medical Devices
The Wall Street Journal; subscription may be required Link to more items from this source
Apr. 16, 2015

"Nearly all U.S. medical devices ... reach the market through an FDA system known as 510(k), which clears tools deemed substantially similar to ones already on the market. That process typically doesn't require clinical studies on people to prove safety and effectiveness.... America's Health Insurance Plans called for strengthening the 510(k) system and efforts to track devices."

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