US judge vacates FDA ruling on MiMedx AXIOFILL regulatory classification

A U.S. federal judge vacated FDA determinations on AXIOFILL’s regulatory status, sending the matter back to the agency for reconsideration.

The court set aside FDA’s view that AXIOFILL is more than minimally manipulated, which would have disqualified it as a Section 361 HCT/P.

The ruling also vacated FDA’s classification of AXIOFILL as a biological product rather than a medical device, calling the agency’s approach arbitrary.

The decision raises the chance AXIOFILL could remain marketed under the less burdensome Section 361 HCT/P pathway, pending FDA’s next steps.