FDA website - Access FDA federal regulations for Protection of Human Research Subjects, Information Sheets, information on early/expanded access to unapproved devices, applications and information on IND, NDA, biologic license and premarket approval:
21 CFR 50 - Protection of Human Subjects This part applies to clinical investigations regulated by the Food and Drug Administration as well as clinical investigations that support applications for research or marketing permits for products regulated by the FDA, such as drugs, medical devices and biological products for human use.
21 CFR 56 Institutional Review Boards This part contains the general standards for the composition, operation and responsibilities of Institutional Review Boards.
21 CFR 312 Investigational New Drug Application This part describes the procedures and requirements governing the use of investigational new drugs. Sponsor and investigator responsibilities are also described in this part.
21 CFR 314 Applications for FDA Approval to Market a New Drug This part describes the procedures and requirements for submitting marketing applications to the FDA. FDA review of the applications is also included in this part.
21 CFR 601 Applications for FDA Approval of a Biologic License
21 CFR 812 Investigational Device Exemptions This part provides procedures for the conduct of clinical investigations of devices. Sponsor and investigator responsibilities are also described in this part.
21 CFR 814 Premarket Approval for Medical Devices This part provides procedures for premarket approval of medical devices intended for human use. Humanitarian Use Devices (HUDs) are described in Subpart H.
FDA Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors
MedWatch Reporting System