A Court Vacated the FDA’s Biologic Classification of MiMedx’s Wound Powder Because Similar Products Were Devices
- A federal judge in the Northern District of Georgia vacated the FDA‘s classification of MiMedx’s wound care powder as a biological product on 22 September 2026, finding the determination arbitrary because the agency had classified similar products as devices, Law360 reported. The case is MiMedx’s challenge over AXIOFILL, a human-derived particulate wound dressing.
- MiMedx launched AXIOFILL in September 2022 as a Section 361 human tissue product, a category that needs no premarket approval. An FDA warning letter in December 2023 said it failed the minimal manipulation criterion, and a March 2024 determination letter confirmed FDA’s view that it is a Section 351 biologic.
- A 351 biologic needs a Biologics License Application, which MiMedx called the most time-consuming and expensive path to approval. It sued in 2024 and kept marketing AXIOFILL while the case proceeded, arguing in March 2025 that FDA had misapplied its own regulations.
- According to Law360, the court vacated the classification and sent it back to FDA rather than classifying the product itself. The opinion text was not available at the time of writing.
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The court did not rule on what AXIOFILL is. It ruled that FDA had not treated like products alike.
- Inconsistency was the ground. MiMedx said in 2024 that three nearly identical human-derived particulates sat on three different paths: one designated a 361 tissue product, AXIOFILL a 351 biologic, and a third cleared as a device through 510(k). The ruling, as reported, rests on that last comparison.
- Lilly argues the opposite side of the same line this week. Its retatrutide case reaches the Seventh Circuit on 24 September, with Lilly seeking biologic status for the 12 years of exclusivity it confers. MiMedx fought to escape biologic status because of what a BLA costs. Product classification is being litigated from both directions, and FDA is defending its consistency in each.
- The principle outweighs the revenue. MiMedx said in late 2023 that AXIOFILL sales were not material to its overall performance, and it licensed a bovine collagen particulate from Regenity Biosciences as a hedge. The ruling’s value is the template: any company whose product FDA classified differently from a near-identical competitor now has a court finding to cite.