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Food & Drug Administration

The Food and Drug Administration (FDA) is an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices. FDA regulations are published as part of chapter 21 of the CFR, and FDA’s human subject protection regulations are in parts 50, 56, 312 and 812.

For more information, please visit FDA's website page on Running Clinical Trials and the sub-page on Regulations.

Content created by Office for Human Research Protections
Content last reviewed on March 18, 2016