MiMedx Group, Inc. v. U.S. Food and Drug Administration et al

  1. September 22, 2026

    FDA Must Revisit MiMedx Wound Care Powder Classification

    A Georgia federal judge vacated the Food and Drug Administration's classification of biomedical company MiMedx's wound care treatment as a biological product, which carries heightened regulatory requirements, finding the agency's determination was arbitrary because it had classified similar products as devices.

  2. September 25, 2025

    MiMedx, FDA Ordered To Rework Args In Wound Care Case

    Biomedical company MiMedx Group Inc. and the U.S. Food and Drug Administration have been ordered to reframe their briefs in a suit in which the company seeks to overturn the agency's classification of a wound care treatment as a biological product.

  3. March 20, 2025

    MiMedx Challenges FDA Classification Of Wound Care Powder

    Biomedical company MiMedx Group urged a Georgia federal judge on Thursday to overturn the U.S. Food and Drug Administration's classification of a wound care treatment as a biological product, arguing the agency misapplied its own regulations.