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 considered medium risk when updating its regulatory approach to such products.
Device-Like System Proposed For Low-Risk Human Cell Therapies, Tissue-Based Products At US FDA
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.
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