November 05, 2002 - The FDA is in the process of revising the regulation of human tissues, cells, and cellular and tissue-based products. The proposed regulatory approach would address a broader scope of products, include more comprehensive requirements to prevent the transmission of communicable disease, and would apply tiered requirements based on the characteristics of such products. Such regulations would affect the way hair cloning research is conducted and how hair cells are harvested and cultured.

The proposed new rule on current good tissue practice (GTP), which includes the methods, facilities and controls used for the manufacture of human cellular and tissue-based products, is the last of three proposals designed to implement FDA’s 1997 “Proposed Approach to the Regulation of Cellular and Tissue-based Products.” The comprehensive risk-based regulatory framework is designed to help ensure the safety and quality of products, including new technologies, without imposing unnecessary regulatory requirements.

The purpose of the GTP regulations is also to help ensure that donors of human cellular and tissue-based products are free of communicable diseases, and that the cells and tissues are not contaminated during manufacturing and maintain their integrity and function. Key elements of the proposed rule are:

• Establishment of a quality program, which would evaluate all aspects of the firm’s operations, to ensure compliance with GTP;
• Maintenance of an adequate organizational structure and sufficient personnel;
• Establishment of standard operating procedures for all significant steps in manufacturing;
• Maintenance of facilities, equipment and the environment;
• Control and validation of manufacturing processes;
• Provisions for adequate and appropriate storage;
• Record keeping and management;
• Maintenance of a complaint file;
• Procedures for tracking the product from donor to recipient, and from recipient to donor.

These fundamental, base-line regulations would apply to manufacturers of all human cellular and tissue-based products. In addition, all of these manufacturers would be required to report adverse reactions and certain product deviations, have adequate labeling that is not false or misleading and allow FDA inspections to ensure compliance with regulations. Certain cellular and tissue-based products that require licensing or premarket approval as biological products or medical devices would be subject to more comprehensive requirements based on their risks.

Two other related proposed rules to implement the 1997 regulatory approach to tissues and cells have already been published. The first one was (“Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products”) published May 14, 1998 and required tissue facilities to register with the FDA and list their products. This proposed rule is currently undergoing review and is expected to be published in final form soon. The other one, (“Suitability Determination for Donors of Human Cellular and Tissue-Based Products”) issued on Sept 30, 1999, focuses on donor screening and testing measures to prevent the unwitting use of contaminated tissues with potential to transmit infectious diseases.

FDA’s current regulations addressing tissues were promulgated in December 1993 with an interim final rule that required the screening and testing of tissue donors for certain transmissible diseases such as HIV and hepatitis, as well as the screening of donors for behavioral risk factors. The final rule, which was published on July 29, 1997, became effective on January 26, 1998.

The new proposed rules are more comprehensive and include provisions for the regulation of innovative products and the latest documents can be seen at http://www.fda.gov/cber/tissue/docs.htm