U.S. Food and Drug Administration (FDA) Guidance

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

Clinical Trials and Human Subject Protection and sub-page on Regulations
(FDA regulations for the conduct of clinical trials)

Information Sheets for Institutional Review Boards, Clinical Investigators, and Sponsors

Medical Device Classification Guide

FDA's Role: ClinicalTrials.gov Information

FDAAA 801 Requirements(Summary information on the clinicaltrials.gov registration and results submission requirements)