FDA Medical Device Division Under Intense Scrutiny

Rick Patterson

Attorney

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In the 1970's Congress asked the FDA to classify devices according to a risk profile. The classes ranged from non-risky Class I bandages to very-risky Class III pacemakers.

Some Class III devices that were on the market before 1976 were allowed to go through a less stringent evaluation, while the FDA developed regulations to address them or decided they were less risky.

Last year, in Riegel vs. Medtronic Inc., 2008 WL 440744 (Feb. 20, 2008 the Supreme Court ruled that a patient may not sue the manufacturer of a device to which FDA has given "premarket approval". The approval simply reflects the determination that the product is reasonable safe and effective for human use. The decision essentially protects device manufacturers from liability after being deemed "reasonably safe."

In January, nine agency scientists authored a letter to then-President-elect Obama in which they accused the FDA of mismanagement, lack of accountability, and even possible corruption. Also in January, the Government Accountability Office released a report criticizing the FDA for incomplete and inadequate regulation of Class III medical devices. Scientists who wrote the report say that the FDA is "fundamentally broken."

Hopefully, the meeting called on Wednesday by the FDA took a serious and critical look at the medical device division and the approval process.