Resources for Food and Drug Administration (FDA)

Watchdog blasts FDA on loose test compliance policy

www.govexec.com

The independent watchdog group Project on Government Oversight revealed Wednesday that top Food and Drug Administration medical-device officials backed off on a requirement that device manufacturers test their products according to federal standards -- the very standards put into place 30 years ago after a prominent lab provided fake data to FDA. The lax oversight instituted in 2006 applies to some of the most critical devices, including cardiac defibrillators, pacemakers, replacement heart valves and coronary artery stents.

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