What this means in a clinic conversation
FDA uses different criteria for structural tissue and cells or nonstructural tissue. The phrase alone cannot establish that a product meets every condition of a regulatory pathway.
A question to bring
Which processing steps occur, and which FDA criteria are being relied on?
Open the visit checklist →Related and commonly confused terms
Sources and editorial context
This definition was compiled from the sources below and has not received independent clinical review. It supports understanding and consultation preparation.
- Minimal Manipulation and Homologous Use guidance · U.S. Food and Drug AdministrationReference checked 2026-10-02