HealthCommentary

Exploring Human Potential

Medical Device Regulation – FDA’s Weakest Link

Bjork-Shiley heart valve Mike Magee Most Americans remain unaware that in the eyes of the FDA not all therapies are considered equal when it comes to regulatory approval and oversight. Drugs are one thing, but medical devices are quite another. As we’ve seen with drug approvals, over the 20th century, organized review and oversight of […]

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