Regulation in the regenerative and stem cell therapy arena is continuing to evolve. Human cells, tissues, and cellular or tissue-based products are currently regulated under Sections 351 and 361 of the Publich Health Service Act. However, a human cells, tissues, and cellular or tissue-based products can be regulated solely under Section 361 of the Public Health Service Act if it is:
- Minimally manipulated
- Intended for homologous use only
- Not combined with another article, and
- Either:
- Does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
- Has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and is for autologous use, use in a first or second-degree blood relative, or reproductive use
