What is the primary focus of 21 CFR 1271?

The primary focus of 21 CFR 1271 is on the regulation of human cells, tissues, and tissue-based products. This regulation establishes the standards for the manufacturing, processing, and distribution of these biological materials to ensure their safety, efficacy, and quality. It addresses various aspects such as donor eligibility, quality control measures, and labeling requirements, with specific guidelines to prevent the transmission of infectious diseases and to ensure that the products meet the necessary regulatory standards before they are used in medical procedures.

This regulation plays a critical role in managing the risks associated with human cell and tissue transplants, as well as promoting public health and safety. Understanding the provisions outlined in 21 CFR 1271 is essential for professionals involved in regulatory affairs, tissue banking, and other related fields. The other choices focus on different areas of regulation and do not pertain specifically to the regulation of human cells and tissues.