RPA Regulatory Advantage

Why RPA is Different: Regulatory Advantage

“Cell Factor” exemption from 21 CFR 1271 biologics regulations due to emission-based production during a 30-day incubation of placenta and umbilical cord.
FDA and CLIA oversight governs donor communicable disease testing, tissue acquisition/transport, production, sterility testing, and packaging — RPA is classified more like a nutraceutical or DESI product.

Legal opinion by ex-FDA, DOJ, and OIG attorneys responsible for 21 CFR 1271 — now at Arnall, Golden, Gregory, D.C. (Documentation available.)

Want to learn more via clinician testimonials, PCR / Endotoxin test results, and white papers on active ingredients?

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These statements have not been evaluated by the Food and Drug Administration. RPA is not intended to diagnose, treat, cure, or prevent any disease. Testimonials are for educational purposes only. Only a licensed clinician and their patient can determine whether RPA or any other therapy is appropriate.