How exosome products are regulated
Most of what circulates about exosome regulation is second-hand and drops the qualifiers that decide the answer. These references quote the regulation and the FDA’s own statements directly, so the reasoning can be checked rather than taken on trust.
Written for licensed practitioners evaluating a supplier, and for sponsors working out what an investigational pathway would require.
References
3 of 6 published. The remainder are in review and will appear as they are completed.
Filing an IND for an Exosome Product
Pre-IND pathway and CBER expectations for EV products.
In review
361 HCT/P vs 351 Biologic
Minimal manipulation, homologous use, and the 21 CFR 1271 tests.
Exosome Clinical Trials: What the Registry Shows
Three defensible counts, a median enrollment of thirty, and why a registration says nothing about whether something works.
CMC Requirements for Exosome Products
Identity, potency, sterility, and stability under an IND.
GMP vs Research Use Only Manufacturing
What RUO designation means, and what changes under GMP.
In review
FDA Communications on Exosome Products
A dated record of FDA statements and enforcement communications.
In review
These references summarize publicly available federal regulation for licensed practitioner education. They are not legal advice, medical advice, or regulatory guidance, and they do not establish that any particular product or practice is compliant. There are no FDA-approved exosome products. Biomolecular signaling vesicle products distributed by ExaVeyra Sciences are supplied for topical aesthetic use by licensed practitioners and for laboratory and IND-authorized clinical research, and are not tissue products as defined by FDA guidelines.