Two pathways
Section 361 — products meeting all 21 CFR 1271.10 criteria. Regulated for communicable disease risk. Registration and listing, no premarket approval.
Section 351 — products failing any criterion. Regulated as biologics. Requires an approved biologics licence application, supported by clinical data.
What moves a product across the line
More than minimal manipulation of the tissue's original relevant characteristics. Non-homologous use. Combination with another article beyond the limited permitted exceptions. Systemic effect or dependence on living cell metabolic activity, outside autologous or close-relative use.
Any one of these is sufficient.
Why this has been contested
The classification determines whether a product can be sold without FDA approval. That is a substantial commercial difference, and it has produced extensive enforcement activity — FDA has issued numerous warning letters to regenerative medicine establishments and has pursued litigation over classification.
The practical implication for patients: a product's pathway is not a matter of the seller's opinion. It follows from what the product is and how it is used, and it can be assessed against published criteria.
This article covers general science and published research. Whether any approach is appropriate for you is a clinical question, answered by a licensed provider through a good-faith exam.
Movera Wellness Institute. Medical services are provided by licensed California practitioners. Supervising physician: Dr. Arnold S. Kremer, DO (CA license #20A4242).