FDA Classification Setback Bodes Well For Wound Care Cos.

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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