With U.S. medical device regulatory reforms looming, comparisons between the U.S. and European systems have become popular talking points in the debate over where FDA should be heading.

In Europe, device oversight is highly decentralized, with significant reliance on accredited thirdparty notified bodies (selected and contracted by manufacturers) and facility inspections, rather than in the U.S., where just about everything goes through FDA.

Recent industry-funded reports have painted FDA as less efficient and competent than its European counterparts, but no more effective at protecting consumers from unsafe devices. (See “ Firms Find FDA Less Efficient, Less Competent Than European Counterparts “ – “The Gray Sheet” Nov. 29, 2010 and “ US-EU recall data “ – “The Gray Sheet” Feb. 7, 2011.)

The debate has even led to defensiveness on both sides of the Atlantic.

In response to criticisms that FDA keeps potentially life-saving technologies out of patients’ hands, CDRH Director Jeffrey Shuren has maintained that Europe has lesser standards compared to the safety and effectiveness review in the U.S. He has suggested that European patients have been put in harms way by devices that were never approved in the U.S. (See “ Shuren: ‘We Don’t Use Our People As Guinea Pigs In The U.S.’ “ – ‘The Gray Sheet” Jan. 24, 2011.)

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