Regulation of Human Cells, Tissues, and Cellular or Tissue-Based Products
In late 2014, the FDA released three draft guidance documents that would dramatically change the regulation of human cells, tissues, and cellular or tissue-based products (HCT/Ps). One of these focused on the scope of the same surgical procedure exception, one focused on what constitutes minimal manipulation of HCT/Ps, and the other focused on HCT/Ps derived from adipose tissue. In each case, the FDA interpreted existing code in a way that would dramatically increase the regulatory requirements associated with some common procedures.
According to the guidance documents, use of previously exempt procedures, including the use of adipose tissue in common fat grafting procedures, would require physicians to register and report as manufacturers. In some cases, such as fat grafting in breast reconstruction, stromal vascular fraction, or in the use of acellular adipose matrix for breast reconstruction, HCT/Ps from adipose would be treated as biological drugs and subjected to even more stringent regulations. Under these regulations, physicians using these products would have to file an application for premarket FDA approval of the products and a license to distribute biologic drugs. Such licenses are only granted after the FDA investigates the personnel, processes, facilities, equipment, and record keeping involved in the manufacture, processing, packing, holding and distributing of a batch or lot of a drug.
Simply put – this is a very, very heavily regulated area. ASPS has been working to educate the FDA on why the science and reasoning behind its interpretations are inaccurate and misguided.