Regulation

How the FDA regulates adipose tissue and cell products, the 361 and 351 pathways, state stem cell laws, and recent court and agency actions.

Three binders, a laptop and a microscope in a glass walled lab office, a setting for the Tissue Reference Group

Regulation

FDA’s Tissue Reference Group: Who Decides Whether a Tissue Product Is 361 or 351

Oscar Tellez 10/21/2026 10:00 AM

Bound guidance document, handwritten notes and coffee on a desk, a reading scene for Plausible Mechanism Guidance

Regulation

FDA’s 2026 Plausible Mechanism Draft Guidance: What It Could Mean for Autologous Cells

Oscar Tellez 10/19/2026 10:00 AM

Glass front lab cabinet with blue capped cryovials set apart behind a divider, how a Tissue Recall hold might look

Regulation

Tissue Recalls: How an HCT/P Recall Works and What It Would Mean for Banked Tissue

Oscar Tellez 10/16/2026 10:00 AM

United States map with brass pins and red string on a walnut table, a picture of Tissue Bank Licensing by state

Regulation

Which States License Tissue Banks, and Why It Matters for Your Banked Tissue

Oscar Tellez 10/15/2026 10:00 AM

Binders, a blank frame and a succulent by a sunny palm window, an office scene for a California Tissue Bank License

Regulation

California Tissue Bank Licensing: What Health and Safety Code 1635 Requires

Oscar Tellez 10/13/2026 10:00 AM

Tissue processing lab with a biosafety cabinet and an audit binder, the space examined in FDA Tissue Inspections

Regulation

FDA Tissue Establishment Inspections: What Part 1271 Subpart F Lets FDA Do

Oscar Tellez 10/12/2026 10:00 AM

Tabbed folder, reading glasses and a gavel by a prairie window, a desk scene for a Montana Stem Cell Law guide

Regulation

Montana’s Experimental Treatment Center Law: What SB 535 (2025) Set Up

Oscar Tellez 10/08/2026 10:00 AM

Leather books and a banker's lamp on a desk by an autumn window, the legal setting of an NY Tissue Bank License

Regulation

New York Tissue Bank Licensing: Why Article 43-B Matters for Banked Tissue

Oscar Tellez 10/07/2026 10:00 AM

Bound court order with a gavel on an oak desk, the kind of document behind a Stem Cell Clinic Injunction

Regulation

The Cell Surgical Network Injunction: What the August 2026 Ruling on Fat-Derived SVF Means for Banked Tissue

Oscar Tellez 10/05/2026 10:00 AM

Oak reception counter with a brass bell, lamp and leather folio, the first stop when checking AATB Accreditation

Regulation

AATB Accreditation: What the 15th Edition Standards Cover, How to Check a Bank, and What Changes January 31, 2027

Oscar Tellez 10/01/2026 10:00 AM