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Appeals Court Checks FDA On Its 510(k) Rescission Authority

In a 2-1 opinion, a federal appeals court ruled that FDA can’t use rescission to reverse a 510(k) clearance if the more time-consuming device reclassification process can accomplish the same ends. The decision sends a collagen knee scaffold device, which previously caused major contention inside FDA, back to the agency for a decision, but more court review might be ahead.

A federal appeals court says FDA overreached in its 2011 decision to rescind a 510(k) clearance for a collagen scaffold device, ruling that the agency cannot use the rescission process as a quicker alternative to the standard notice-and-comment device reclassification process.

On Sept. 26, a 2-1 panel majority of the U.S. Court of Appeals for the D.C. Circuit reversed a 2013 district court ruling that supported FDA’s rescission authority. Under the...

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