FDA 21 CFR Covers Primary Regulations for Conducting of Investigational Device Exemptions Medical Device Clinical Studies

21 CFR 812, Investigational Device Exemptions (IDE)

It covers the procedures for the conduct of clinical studies, application, responsibilities of sponsors and investigators, medical device labeling, records, and reports.

21 CFR 820 SubpartC, Design Controls of the Quality System Regulation

It provides the requirement for procedures to control the design of the device.

21 CFR 50, Protection of Human Subjects

It provides the requirements and general elements of informed consent.

21 CFR 56, Institutional Review Boards

It covers the procedures and responsibilities for an IRB that approves clinical investigations protocols.

21 CFR 54, Financial Disclosure by Clinical Investigators

It covers the disclosure of financial compensation to clinical investigators that are part of the FDA’s assessment of the reliability of the clinical data.