What is FDA Compliance?

FDA Compliance Definition

FDA (Food and Drug Administration) compliance refers to the regulations set forth to protect the public health. FDA regulations help ensure the safety, efficacy, and security of drugs, medical devices, and biological products. Medical device and biotechnology companies must adhere to FDA 21 CFR Part 820, Part 11, and other quality system requirements (QSR) to be able to sell products in the United States.