Another Win for HCT/P Manufacturers: Court Vacates and Remands FDA’s AXIOFILL Determination October 2, 2026 By Steven J. Gonzalez & Peter G. Dickos & Adrienne R. Lenz, Principal Medical Device Regulation Expert —

Another Win for HCT/P Manufacturers: Court Vacates and Remands FDA’s AXIOFILL Determination October 2, 2026 By Steven J. Gonzalez & Peter G. Dickos & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 21, 2026, the U.S. District Court for the Northern District of Georgia handed the regenerative medicine industry a significant win, vacating two key FDA determinations regarding MiMedx Group, Inc.’s wound-care product AXIOFILL. The decision, MiMedx Group, Inc. v. FDA, No. 1:24-cv-01287 (N.D. Ga. Sept. 21, 2026), addresses foundational questions about how FDA evaluates whether a human cell, tissue, and cellular and tissue-based product (HCT/P) is “minimally manipulated,” and whether the Agency can classify a product as a biological product when it has treated materially similar products as medical devices. Especially because FDA recently lost a similar case before a different district court, Vitti Labs, LLC v. FDA, No. 25-cv-011 (W.D. Mo. Mar. 18, 2026), motion to alter or amend judgment denied (Aug. 28, 2026), the ruling carries potentially broad implications for manufacturers of HCT/Ps, particularly those derived from placental tissue, as it would constrain FDA’s analytical framework and demand consistency in the Agency’s biologic vs. device classification decisions. https://www.thefdalawblog.com/2026/10/another-win-for-hct-p-manufacturers-court-vacates-and-remands-fdas-axiofill-determination/?utm_source=rss&utm_medium=rss&utm_campaign=another-win-for-hct-p-manufacturers-court-vacates-and-remands-fdas-axiofill-determination