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

This article was originally published in The Gray Sheet

Executive Summary

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.

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