What does 21 CFR 1270 regulate?

The regulation outlined in 21 CFR 1270 specifically addresses the safety and effectiveness of human tissues intended for transplantation. This part of the Code of Federal Regulations sets forth guidelines to ensure that human tissues are collected, processed, stored, and distributed in a manner that minimizes the risk of disease transmission to the recipient and ensures compliance with essential safety standards.

The regulation highlights the importance of rigorous procedures in the handling of human tissues to protect public health, which is crucial given the potential risks associated with transplantation. This focus on human tissues intended for transplantation underscores the need for strict oversight and quality control in the management of such biological materials.

While other options mention significant subjects within regulatory affairs, such as medical devices and pharmaceutical manufacturing, they fall under different sections of the CFR. For instance, human cells and tissues that do not fall under the specific transplantation category are addressed under separate regulations, and medical devices are governed by other parts of the CFR dedicated to their respective safety and effectiveness protocols.