WASHINGTON—The Food and Drug Administration is struggling to determine whether it has authority to re-evaluate a knee device that it had earlier cleared, raising questions about the scope of the agency’s powers and injecting fresh uncertainty into the medical-devices sector.
The questions have emerged ahead of an FDA meeting of outside orthopedic surgery experts Tuesday. An agency committee will re-examine the Menaflex knee-repair device made by ReGen Biologics Inc..
The head of the FDA’s device division had approved the knee device in December 2008 after repeated objections from FDA scientists and managers. After an Wall Street Journal article last year …
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