Disable ads (and more) with a membership for a one time $2.99 payment
In the United States, which agency is responsible for regulatory oversight of tissue banking?
AATB
OSHA
DHHS
FDA
The correct answer is: FDA
The agency that is responsible for regulatory oversight of tissue banking in the United States is the FDA, or the Food and Drug Administration. The FDA has established regulations and guidelines specifically for human tissues and cellular products under the section of 21 CFR Part 1271. This part outlines the requirements for the donor screening, recovery, processing, storage, and distribution of human tissue intended for transplantation. The FDA's role ensures that tissue banks adhere to quality standards that safeguard public health, making it a critical authority in this field. Other agencies mentioned, such as AATB (American Association of Tissue Banks), serve more as professional organizations that provide accreditation and guidance but do not have the regulatory authority that the FDA possesses. Similarly, OSHA (Occupational Safety and Health Administration) is focused on workplace safety and health, and DHHS (Department of Health and Human Services) oversees various health-related aspects but does not specifically regulate tissue banking in the same manner as the FDA. This distinction highlights the FDA's primary role in ensuring compliance with safety and efficacy standards in tissue transplantation.