Why aren all HCT/Ps licensed, approved, or cleared?
FDA’s tissue regulation is a risk-based approach to cell and tissue regulation. Regulation focus on three general areas: 1) limiting the risk of transmission of communicable disease from donors to recipients; 2) establishing manufacturing practices that minimize the risk of contamination; 3) requiring an appropriate demonstration of safety and effectiveness for cells and tissues that present greater risks due to their processing or their use. HCT/Ps that meet the criteria in Section 1271.10 are regulated solely under section 361 of the Public Health Service Act. These HCT/Ps must meet only the requirements in 21CFR Part 1271 and are not required to be licensed, approved or cleared. For HCT/Ps not meeting the criteria established in Section 1271.10, FDA premarket review (including a license, approval, or clearance) is required.
