Читать книгу Anti-Aging Therapeutics Volume XIV - A4M American Academy - Страница 15

The FDA regulates drug, supplements, and devices but does not directly regulate practitioners. This oversight is provided by the state boards of medicine. FDA CFR Title 21 part 1271 concerns the regulation of human cells and cellular products. It states the physician is in compliance if the cell products are removed and re-implanted into the same patient during the same procedure. These cells must also be “minimally manipulated”. This has been interpreted to mean that centrifugation and cell selection is permissible but cell expansion and tissue culture is not. It should be recognized that regulations are likely to change in areas such as these where technology is evolving quickly.