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Federal Appeals Court Finds FDA Exceeded its Authority in Reclassifying ReGen's 510(k)

The U.S. Court of Appeals for the District of Columbia Circuit ruled that FDA has no “inherent reconsideration authority” to reclassify 510(k) cleared devices without proper notice and comment procedures.

The ruling found in favor of Ivy Sports Medicine, formerly ReGen Biologics, which had a storied history with FDA that involved several findings that ReGen’s scaffold wasn’t substantially equivalent, political pressure from ReGen’s congressional delegation and direct involvement from CDRH’s director at the time. An expert advisory panel was later convened and determined the scaffold to be substantially equivalent.

After the clearance, the press alleged that the approval was granted as a result of outside influence and FDA’s newly appointed Acting Commissioner ordered an internal investigation of the Collagen Scaffold’s review process. FDA stated the clearance process had procedural irregularities, so it revoked its substantial equivalence determination, reclassifying the device from a Class II to a Class III and withdrawing the product from the market.

Ivy Sports challenged FDA’s reclassification decision in June 2011 as procedurally flawed and argued that FDA did not follow the procedure laid out in statute to reclassify their device. The recent ruling determined that FDA did in fact act outside of its authority.