FDA Issues Final Guidance on When Manufacturers of Lower Risk Human Cells, Tissues, and Cellular and Tissue-Based Products Must Report Problems

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By the WoundSource Editors

Silver Spring – September 6th, 2017 – The final guidance, "Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271," explains when it is necessary for manufacturers of certain human cells, tissues, and cellular and tissue-based products (HCT/Ps), which do not require FDA premarket review and approval, to report to the agency when infectious disease testing or determination of other donor eligibility criteria have not been performed properly. While this is not a new requirement, the final guidance seeks to provide greater clarity to industry on how to properly follow the regulations already in effect. Specifically, the FDA is issuing this guidance to provide establishments that manufacture non-reproductive HCT/Ps with specific recommendations and relevant examples for complying with the applicable requirements to investigate and report HCT/P deviations to the FDA.

"The FDA takes a risk-based approach to regulating human cells, tissues, and cellular and tissue-based products; providing greater oversight to those products that are associated with greater risks to patients. However, even lower risk products such as orthopedic tissue used for replacement of ligaments still have the potential to spread dangerous communicable disease. As the agency responsible for overseeing these products, the FDA needs to be aware of problems so we can help identify issues quickly and limit any further infection," said FDA Commissioner Scott Gottlieb, M.D. "Today’s policy action is another step forward in our development of a comprehensive framework for regulating cell and tissue products, one that provides clear rules and balances patient protection with the need for efficient oversight of these technologies."

Proper and timely reporting of HCT/P deviations helps the FDA and the industry identify and respond to outbreaks and other trends that may be occurring across the field. This guidance describes scenarios to illustrate who must investigate and report HCT/P deviations, what must be reported, and when such reports must be submitted to the FDA. Because timely and accurate reporting of HCT/P deviations has been of considerable interest to industry stakeholders, this guidance provides examples of both reportable and non-reportable events. The examples provided in this guidance have been chosen to illustrate the most frequently reported HCT/P deviations that have historically been submitted to the FDA. They are not all-inclusive and do not represent all variations that may occur. For these reasons, the FDA encourages communication and inquiries to help ensure proper reporting of HCT/P deviations. The agency also makes this information available in annual summaries on deviation reporting.

About the FDA
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. Visit www.fda.gov for more information.

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