The U.S. Food and Drug Administration has published two final guidance documents that are part of a comprehensive policy framework to address how the agency plans to support and expedite the development of regenerative medicine products, including human cells, tissues, and cellular and tissue-based products (HCT/Ps). These guidance documents build upon FDA’s risk-based, flexible regulatory framework, and underscore the agency’s commitment to help bring new and innovative treatment options to patients.
The final guidance documents are:
- Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use
- Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception
The final guidance on minimal manipulation and homologous use are intended to provide clarity in the determination of whether HCT/Ps are subject to FDA’s premarket review requirements. The final guidance on the same surgical procedure exception is intended to provide clarity as to whether an establishment may qualify for an exception from the requirements under Part 1271 by meeting the exception in 21 CFR 1271.15(b).
The FDA is also publishing two new draft guidances, which are intended to aid in the effort to bring innovative, safe, and effective products to patients as efficiently as possible…