The New York Times’ Reed Abelson reports on the Food and Drug Administration’s "quick-review" process for approving new medical devices that the FDA deems as similar to pre-existing devices on the market. The rule was designed when medical devices were first regulated in 1976 so that makers of new and improved devices like heart catheters or artificial hips would not be at a competitive disadvantage. But, using the example of a new radiation method for breast cancer, Abelson shows that that the FDA seal of approval is not sufficient for some doctors.

The article does not fully go into the politics around these medical devices. For one, the FDA has received bipartisan criticism for being woefully under-funded, under-staffed, and unprepared to regulate new medical technologies. Also, a Supreme Court case in February said that an FDA rule on a medical device preempts state legislatures from making their own regulations.

In other words, the government is currently not fully inspecting medical devices that could mean life or death to patients.-MB

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