510(k) Clearance Standards At Issue In Federal Appeals Court Case
This article was originally published in The Gray Sheet
Executive Summary
Cytori Therapeutics is suing FDA, alleging that the agency illegally denied two 510(k) clearances based on reviewer concerns about potential off-label use of the firm’s stem-cell harvesting devices. It is a rare instance of a company challenging a “not substantially equivalent” decision in the courts.
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