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

Guidance documents do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statue, regulations, or both.

FDA Regulations

FDA Homepages

FDA main homepage
CDER home (drugs)
CDRH home (devices & radiological health)
CBER home (biologics)

CFR Title 21

21 CFR 11: Electronic Records; Electronic Signatures
21 CFR 50: Protection of Human Subjects, Informed Consent
21 CFR 54: Financial Disclosure
21 CFR 56: Institutional Review Boards
21 CFR 312: Investigational New Drugs
21 CFR 314: FDA Approval to Market a New Drug (NDA)
21 CFR 600: Biologics, general
21 CFR 601: Biologics, licensing
21 CFR 812: Investigational Devices
21 CFR 814: Medical Devices, Pre-Market-Approval (PMA)
21 CFR 860: Medical Devices, Classification Procedures

FDA Guidance and Information Sheets:

Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
FDA Guidance Documents Index

FDA commonly used links:

Device advice
FAQ: IRB review of Medical Devices
Information for Health Professionals
A Guide to Informed Consent
Significant Differences between HHS and FDA regulations
FDA regulations: special protections for children
"Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices
Index, Information for FDA-regulated Industry
FDA Enforcement Activities
FDA Warning Letters