By Steven Gonzalez, Peter Dickos and Adrienne Lenz ( November 3, 2026, 2:15 PM EST) -- In MiMedx Group Inc. v. U.S. Food and Drug Administration,[1] the U.S. District Court for the Northern District of Georgia on Sept. 21 handed the regenerative medicine industry a significant win, vacating and remanding the FDA's designation of MiMedx's wound care product Axiofill as a biological product, instead of a medical device or a human cell, tissue, and cellular and tissue-based product, or HCT/P, regulated under Section 361 of the Public Health Service Act....
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