FDA Issues Final Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products

This notice is to inform you that the FDA has issued the final "Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." This Guidance finalizes, and replaces, the draft guidance of the same title published in January 2009.

As you may recall, the FDA HCT/P regulation (21CFR Part 1271) is comprised of several parts. Subparts A (General Provisions); B (Procedures for Registration and Listing); C (Donor Eligibility); and F (Inspection and Enforcement of Establishments) are not included in this Guidance for Industry although they may be referenced and related to this Guidance.   This Guidance deals directly with Subparts D (Current Good Tissue Practice) and E (Additional Requirements for Establishments).

At this time only 2 sections of Subpart D (1271.150(c) and 1271.155) and none of Subpart E apply to reproductive HCT/P establishments regulated solely under section 361 of the Public Health Services (PHS) Act (this includes the majority of infertility centers). Therefore, for most reproductive establishments this Guidance does not implement a change from previous Guidance.

1271.150(c) relates to manufacturing arrangements. This Guidance offers suggestions as to how an establishment may meet the requirements regarding manufacturing arrangements such as those with testing facilities performing infectious testing for donors.  

1271.155 relates to exemptions and alternatives.

Recall that FDA Guidance documents may not be legally enforceable (see excerpt below) but they do provide direct insight into the thoughts of FDA and are a good indication of what FDA investigators will be looking for during a site visit.

Excerpt from the Introduction of this Guidance: "FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA's guidances means that something is suggested or recommended, but not required."

Click here to view the complete Guidance document. 

Click here to access other helpful guidance documents.