Medical Device FDA Regulation: The Basic Problem.

Mike Magee A global investigative report has shone an unwelcome light on a largely unregulated industry we exposed in detail almost one year ago – the medical-device industry. The report documented that the 190,000 devices currently on the market have been responsible for 1.7 million injuries and some 83,000 FDA reported deaths over the past decade. […]

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 […]