Home » News Articles Lead to EC Gripe With FDA’s Shuren
News Articles Lead to EC Gripe With FDA’s Shuren
A quote from CDRH Director Jeffrey Shuren alleging the EU device regulatory system uses the public as “guinea pigs” has drawn ire from the European Commission (EC) after it appeared in news articles. EC Directorate-General for Health and Consumers Paola Testori Coggi sent a letter of complaint to FDA Commissioner Margaret Hamburg, citing a D&DL story that featured the quote. “I am deeply concerned that a senior official of the FDA should publicly discredit the regulatory system in Europe in this way,” Coggi says in the Feb. 18 letter, obtained Friday.
Devices & Diagnostics Letter
Devices & Diagnostics Letter
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