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FDA Will Not Broadly Release Report Criticizing EU Oversight

The agency decided not to widely disseminate a report examining 12 high-risk devices that were approved in Europe, but were later found to be dangerous or ineffective.

FDA has decided not to broadly release a recently finalized internal report that strongly criticizes the European decentralized device regulatory system for allowing “unsafe” products onto the market.

The report – “Unsafe and Ineffective Devices Approved in the EU That Were Not Approved in the U.S.” – was first reported by the Minneapolis-based Star Tribune April...

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