The HCT/P Modernization Act of 2025

This bill aims to make the FDA’s rules for products made from human cells or tissues clearer, faster, and easier to follow. These products are treatments that contain or consist of human cells or tissues used in people. The FDA must post plain-language materials about the Tissue Reference Group—an FDA team that answers product questions and gives advice on how these products are regulated—and share yearly numbers on registrations, inspections, questions received, and how long responses take.

The FDA must also teach and hold workshops for patients, hospitals, researchers, and companies, open a public comment page to gather ideas on updating the rules, and send Congress a report with recommendations that balance safety, access, science, and paperwork.

• Who is affected: Patients who may use these treatments; clinics and hospitals; researchers; and companies that make or use human cell and tissue products.
• What changes: More public info and transparency about the FDA’s Tissue Reference Group; education and workshops; a public comment docket; and a formal report with recommended updates.
• When: Public comment page within 60 days of the law taking effect; website data within 1 year and then every year for 3 years; report due by September 30, 2026.