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.
Tissue banking was regulated solely by the private sector until serious adverse events began occurring due to a lack of communicable disease testing. Ultimately, the FDA was forced to step in and create guidelines to mitigate public health risk. Now the FDA requires testing for a wide array of communicable diseases, helping to ensure public health.
Looking for a more in-depth explanation of Section 361?
See our Understanding 361 page on our website, which thoroughly explains this criteria and how it relates to you and our products.
Ask about our IRB-backed Study Program, where we follow patient outcomes and discover new homologous uses for our 361 products.