The American Amnion Association (AaA) commends the American Association of Tissue Banks (AATB) for their visionary leadership and thoughtful recommendations presented during the February 25, 2025, FDA Workshop on “Cell Therapies and Tissue-Based Products.”
The AATB’s recommendations advocate for a revised, risk-based framework for the regulation of 351 Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), a move the AaA views as a significant step forward for the advancement of innovative amnion-based products.
In a letter addressed to Dr. Peter Marks and Ms. Julie Tierney of the FDA’s Center for Biologics Evaluation and Research (CBER), the AATB emphasized the need to modernize the regulatory approach for 351 HCT/Ps, ensuring the level of regulatory oversight is proportionate to the actual risk and complexity of a product. AaA leadership echoes AATB’s position that the current one-size-fits-all Biologics License Application (BLA) pathway poses unnecessary burdens—particularly for low- and medium-risk products like amnion-derived tissue grafts used in wound healing.
“The American Amnion Association fully supports AATB’s call for differentiated regulatory pathways,” said Jerry Pascucci, President of the American Amnion Association. “Their proposed framework would help bring safe and effective amnion products to market more efficiently, while maintaining high standards for patient safety and product quality, as well as could revolutionize the development and accessibility of innovative tissue-based therapies, including amniotic products.”
AATB’s recommendations included:
Creation of a Low-Risk 351 Category for minimally manipulated, nonhomologous-use products (e.g., amniotic tissue grafts for wound healing), potentially subject to a 510(k)-like pathway.
Creation of a Medium-Risk 351 Category for more complex products, with PMA – like processes that require fewer or smaller clinical trials than the current BLA.
Application of Good Tissue Practice (GTP), with special controls as needed, rather than imposing full Good Manufacturing Practice (GMP) requirements on low- and medium-risk products.
Improved Regulatory Predictability through clarified guidance, transparent evidentiary requirements, and faster FDA feedback mechanisms.
The AaA believes these reforms could unlock the full potential of amnion-based therapies — especially in areas like regenerative medicine and chronic wound care —by accelerating innovation, improving access, and reducing time-to-market for responsible manufacturers.
“Amnion products are transforming the way we treat wounds, manage pain, and restore tissue and the AATB has struck a thoughtful balance between innovation and safety,” Pascucci continued. “We commend the AATB for its leadership in advocating for a more balanced and efficient regulatory system. If the FDA adopts these recommendations, we can ensure these innovations are developed under a smarter, science-based regulatory system where innovations thrive and patients benefit.”
The AaA urges the FDA to give serious consideration to AATB’s recommendations and looks forward to collaborating with AATB, CBER, and other stakeholders to shape a regulatory pathway that reflects the evolving landscape of tissue-based therapies.