US judge vacates FDA ruling on MiMedx AXIOFILL regulatory classification
Bitget2026/09/23 20:01- 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.
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