Regenerative and stem cell therapy practices part 22

Stem cell 2


The difference between human cells, tissues, and cellular or tissue-based products that is regulated under both sections of the public Health Service Act, as opposed to solely under Section 361, is significant for providers of stem cell treatments since the requirements for pre-market authorization of  a product are much more stringent under Section 351 and require conducting clinical investigations under an investigational new drug (IND) application and obtaining a biologics license through the FDA, whereas requirements under Section 361 focus only on the prevention of communicable diseases. This represents a lower regulatory threshold for human cells, tissues, and cellular or tissue-based products; their use and transplantation can be considered to fall under the practice of medicine and would, therefore, be regulated by state medical boards.

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