FDA Updates Human Cell, Tissue Guidance for Hospitals, Labs

Hospitals can bypass the FDA’s cell and gene therapy requirements if they’re only using them for non-clinical, scientific, or educational purposes or are performing bone marrow transplants or similar surgeries without sharing or distributing them.

The Food and Drug Administration issued a final guidance document Monday that aims to help small entities comply with the agency’s regulation of human cellular and tissue-based products, or HCT/Ps.

The latest version updates a 2007 document to account for a 2016 rule designed to make it easier to donate frozen embryos to another individual or couple as well as a separate 2016 rule to ...