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Device-Like System Proposed For Low-Risk Human Cell Therapies, Tissue-Based Products At US FDA

 
• By Kate Rawson

A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.

The FDA wants to revamp its current regulatory framework for human cell and tissue-based therapies. (Shutterstock)
Key Takeaways
  • The CMO of the American Association of Tissue Banks proposed using a 510(k)-like regulatory framework for low-risk cell and tissue products and a PMA-like system for medium risk products to reduce the regulatory burden, while high-risk products would continue to be regulated via a BLA.
  • The FDA has indicated the current system needs to be revamped to alleviate confusion about product classification and fight bad actors taking advantage of it.
  • CBER Director Peter Marks said the agency is early in the process for determining alternative frameworks.

The US FDA’s Center for Biologics Evaluation and Research could consider establishing a 510(k)-like pathway for low-risk human cells, tissues and tissue-based (HCT/P) products and a PMA-like pathway for those...

American Association of Tissue Banks Chief Medical Officer Melissa Greenwald proposed the framework during a February CBER-sponsored workshop on HCT/P products, arguing that a risk-based approach...

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