Federal Regulations

While this page is not intended to provide a detailed overview of all federal regulations, the following are key links to regulations of U.S. agencies that govern clinical research and clinical trials. 

The Food and Drug Administration (FDA), 21 CFR 50, 21 CFR 56, and the Food, Drug, and Cosmetic Act.

 FDA guidance on good clinical practice (GCP) and the conduct of clinical trials.

The Department of Health and Human Services (DHHS), Office of Human Research Protection (OHRP), 45 CFR 46.

The Belmont Report was written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

Investigator Responsibilities for Investigational New Drug (IND) Applications.

Investigational Device Exemption (IDE) is REQUIRED prior to the initiation and enrollment of study participants in an investigational device study. To find the classification, as well as whether any exemptions may exist, you need to find the regulation number that is the classification regulation for the device. There are two methods for accomplishing this: go directly to the classification database and search for a part of the device name, or, if you know the device panel (medical specialty) to which the device belongs, go directly to the listing for that panel and identify the device and the corresponding regulation.