Certain stem cell products fall under the definition of a HCT/P. If so, unless an exception is met, the product will be subject to regulation by various laws and regulations such as the Food, Drug and Cosmetic Act (“FDCA”), Public Health Safety Act (“PHSA”), and 21 CFR 1271. When determining which apply, 21 CFR 1271.10(a) and the exception in 21 CFR 1271.15(b) (i.e. the “Same Surgical Procedure Exception”) must be reviewed. However, many are left asking: what is the relationship between the same surgical procedure exception and the four criteria set forth in 21 CFR 1271.10(a)? Thanks to recent guidance released by the FDA, some clarification has arrived.
The U.S. Food and Drug Administration (“FDA”) has implemented a tiered, risk approach to the regulation of human cells, tissues, and cellular and tissue-based products (“HCT/Ps”). HCT/Ps, essentially stem cell business, that meet certain criteria under 21 CFR 1271 are only subject to limited regulation and have no requirement to obtain full premarket approval. An analysis of recent warning letters and inspectional data reveals that the FDA continues to crack down on health care providers and manufacturers offering to use adipose stromal vascular fraction (“SVF”) products to treat a wide variety of conditions. The common conclusion by the FDA: SVF products are more than minimally manipulated and not intended for homologous use meaning that pre-market approval is required.
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