Most people have never even heard of FDA regulations, “Section 361” or “Section 351”, so what are these regulations & where did they originate?
Section 361 was created by the FDA in the 1990s to regulate human cell and tissue products (HCT/Ps) that do not pose a significant risk to public health and thus do not require an IND or premarket approval to be commercially sold.In the same legislation, Section 351 was created by the FDA to regulate human cells and tissue products (HCT/Ps) that have a higher risk of posing a significant risk to public health, thus requiring an IND or premarket approval to be commercially sold.
