The FDA’s Deadly Gamble with the Safety of Medical Devices

[Guest Marthena Cowart]

Internal documents which show that senior officials at the FDA’s Center for Devices and Radiological Health put an end to the enforcement of a critical FDA safety regulation meant to ensure that defective devices—cardiac defibrillators, for example—are not allowed to be used in patients in clinical trials.

 

The decision announced internally to employees in 2006 and with no public notice, is no harmless blunder. It is a high‑stakes, unknown‑odds gamble with the lives of patients past, present, and future.