FDA Section 361 & Section 351 Regulatory History
FDA Regulatory History in chronological order dating back to 1993.
Section 361 Regulatory Criteria
FDA’s Section 361 and Section 351 Origination
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.
Section 361 vs. Section 351
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Where did tissue banking originate?
Human tissue allografts have been used on wound and burn patients for over 150 years. The US Navy established the first tissue bank in the United States in 1949. Today, there are more than 120 tissue banks across the nation.
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.
Organ and Tissue Transplant HistoryLooking 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.
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