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 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.
A link to 1271.10 is:
http://a257.g.akamaitech.net/7/257/2422/10apr20061500/edocket.access.gpo.gov/cfr_2006/aprqtr/21cfr1271.10.htm
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