JD Supra

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

On March 18, 2026, Chief Judge Brian C. Wimes of the U.S. District Court for the Western District of Missouri issued a significant ...
RAPS

FDA Releases New Draft Guidance on Medical Device Classification Product Codes

The FDA released new draft guidance for industry on Tuesday titled, Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Classification Product Codes. Classification ...