FDA Must Revisit MiMedx Wound Care Powder Classification

By Danielle Ferguson · September 22, 2026, 7:57 PM EDT

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...

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Case Information

Case Title

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

Case Number

1:24-cv-01287

Court

Georgia Northern

Nature of Suit

Other Statutes: Administrative Procedures Act/Review or Appeal of Agency Decision

Date Filed

March 25, 2024