Monday, January 30, 2012 8:07 PM
Device Ombudsman Lists Complaints
The CDRH reports a 44 percent increase in complaints compared with 2010, and lists other contacts that the agency had with the public last year.
The Ombudsman's office for FDA's medical device arm, Center for Devices and Radiological Health, released details of the contacts it had with the public last year, including complaints of its review process. According to the report, there were 461 new contacts in 2011, 11 percent more than during the prior year. These included questions, requests for clarification, or issues that don't rise to the level of a complaint or a dispute. (According to FDA, “A complaint is typically more...
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