FDA Issues Guidance to Tissue Establishments

The Food and Drug Administration (FDA) is reminding companies that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) that they must comply with FDA regulations.

The issuance of the guidance to industry follows two recently identified cases of serious violations of safety requirements pertaining to the recovery of tissues, and subsequent FDA actions to stop the operations. This guidance is intended to ensure that companies involved in any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of any human cell or tissue, and screening or testing of the cell or tissue donor, are aware of their regulatory responsibilities.

"Patient safety is our primary concern," said Jesse Goodman, MD, MPH, director of FDA's Center for Biologics Evaluation and Research (CBER). "This guidance serves to emphasize the important role that manufacturers play in enhancing tissue safety by helping to ensure that those that perform work for them also comply with the regulations. This is consistent with the efforts, which we applaud, of professional associations to foster quality and compliance with FDA regulations by all involved."

Current good tissue practices (CGTP) require manufacturers to recover, process, store, label, package and distribute human cells or tissues in a way that prevents the introduction, transmission, or spread of communicable diseases and prevents contamination during manufacturing. All tissue establishments are required to comply with the regulations applicable to the manufacturing steps they perform. FDA will act as needed to ensure that tissue establishments, including tissue recovery firms, are in full compliance with applicable requirements. However, another important safeguard is the requirement that, if a manufacturer enters into a contract, agreement or other arrangement with another establishment to perform any step in the manufacturing process (such as recovery), the manufacturer takes steps to ensure that such an establishment also complies with applicable CGTPs. Such steps have already been very important in helping identify and correct potential problems.

In addition to this action, FDA's Human Tissue Task Force (http://www.fda.gov/bbs/topics/NEWS/2006/NEW01440.html) will complete a comprehensive evaluation of the first year of implementation of the agency's newly promulgated regulations which require manufacturers to comply with CGTP and donor eligibility requirements. These requirements were finalized in 2005. The task force, which is led by senior FDA officials, was established as part of the agency's efforts to strengthen its risk-based system for regulating human cells and tissue.

For a copy of the guidance, visit: http://www.fda.gov/cber/gdlns/cgtpmanuf.htm