What did the FDA announce in its 2017 Guidance regarding Human Cells, Tissues, and Cellular Products?

In the 2017 Guidance regarding Human Cells, Tissues, and Cellular Products, the FDA introduced a compliance and enforcement discretion policy. This policy signified a shift in how the FDA approached the regulation of certain human cells, tissues, and cellular products, allowing for a more nuanced review and oversight based on the risk associated with the products. Under this guidance, decisions on regulatory applications were made with specific attention to the context and characteristics of the products, rather than applying a one-size-fits-all regulation.

The idea of enforcing discretion is significant because it recognizes the complexity and diversity within the category of human tissues and cells. Rather than imposing strict regulations across the board, the FDA aimed to focus its resources on higher-risk products while allowing lower-risk products to be more readily accessible, thus facilitating innovation while ensuring safety.

This contrasts with a strict ban on all product submissions or a requirement for immediate marketing applications, which would have restricted access to potentially beneficial therapies and products. Additionally, the option regarding only IND submissions being exempted does not reflect the broader scope of the compliance policy, which encompasses various types of cellular and tissue products. Therefore, the introduction of a compliance and enforcement discretion policy was a balanced approach the FDA took to better manage the evolving field of regenerative