By: Matt Fischer
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. Continue reading
