Federal Court Hands Major Win to Tissue Product Manufacturers – FDA’s HCT/P Classification Decision for Umbilical Cord–Derived Product CORDGRAFT Rejected

June 27, 2026

On March 18, 2026, Chief Judge Brian C. Wimes of the U.S. District Court for the Western District of Missouri issued a significant decision overturning the U.S. Food and Drug Administration’s (“FDA”) classification of Vitti Labs’ umbilical cord–derived product, CORDGRAFT. See Vitti Labs, LLC v. U.S. Food & Drug Administration, No. 4:25‑cv‑00011‑BCW, slip op. (W.D. Mo. Mar. 18, 2026)….
By: Benesch

Federal Court Hands Major Win to Tissue Product Manufacturers – FDA’s HCT/P Classification Decision for Umbilical Cord–Derived Product CORDGRAFT Rejected

Supreme Court Holds Roundup Failure-to-Warn Claim Preempted by Federal Law

Proposed Rule on CUI and CUI Incident Reporting Would Create New Requirements and Risks for Contractors