REGULATIONS USA ----------------------------------------------------------------------------------------------- Electronic Records; Electronic Signatures Regulation (21CFR11) Financial Disclosure by Clinical Investigators (21CFR54) Institutional Review Boards (IRB) (21CFR56) Investigational Device Exemption (IDE) (21CFR812) Investigational New Drug Application (NDA) (21CFR312) Protection of Human Subjects (Consent) (21CFR50) Premarket Approval of Medical Devices (21CFR814)