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."