5/31/2013

The FDA's draft guidance clarifying its requirements on medical device recalls has elicited concerns from the industry. "[W]e believe significant aspects of the Draft Guidance are at odds with existing FDA regulation and policy, and that it is necessary to resolve these discrepancies prior to issuing guidance or regulation in this area," AdvaMed said. Boston Scientific echoed AdvaMed's concerns, saying the guidance "has not achieved its purpose in clarifying the difference between product enhancements and recalls."

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