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Why were tissue banks unregulated until 1993? 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. https://www.donoralliance.org/newsroom/donation-essentials/the-history-of-organ-and-tissue-transplants-in-the-usa/
  • 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.