TABLE 1.

Federal Regulations That Apply to the IDE Application Process for Sponsor-Investigators

Code of Federal Regulations Title 21, PART 812 SUBCHAPTER H--MEDICAL DEVICES
Subparts and sections discussed in text
Subpart A —	General Provisions
Sec. 812.2	Applicability
Sec. 812.2 (b)	Abbreviated Requirements
Sec. 812.2 (c)	Exempted investigations
Sec. 812.3	Definitions
Sec. 812.5	Labeling of investigational devices
Sec. 812.7	Prohibition of promotion and other practices
Sec. 812.19	Address for IDE correspondence
Subpart B —	Application and Administrative Action
Sec. 812.20	Application
Sec. 812.25	Investigational plan
Sec. 812.27	Report of prior investigations
Sec. 812.30	FDA action on applications
Sec. 812.35	Supplemental applications.
Subpart C —	Responsibilities of Sponsors
Sec. 812.40	General responsibilities of sponsors
Sec. 812.42	FDA and IRB approval
Sec. 812.46	Monitoring investigations
Subpart D —	IRB Review and Approval
Sec. 812.62	IRB approval
Sec. 812.66	Significant risk device determinations
Subpart E —	Responsibilities of Investigators
Sec. 812.100	General responsibilities of investigators
Sec. 812.110	Specific responsibilities of investigators
Subpart G —	Records and Reports
Sec. 812.140	Records
Sec. 812.150	Reports
Other Relevant Code of Federal Regulations
45 CFR Part 46	Protection of Human Subjects
21 CFR Part 50	Protection of Human Subjects
21 CFR Part 56	Institutional Review Boards
21 CFR Part 54	Financial Disclosure by Clinical Investigators
21 CFR Part 801	Labeling (Devices)
21 CFR Part 58	Good Laboratory Practice for Nonclinical Laboratory Studies
21 CFR Part 803	Medical Device Reporting
21 CFR Part 809	In Vitro Diagnostic Products For Human Use
21 CFR Part 814	Premarket Approval of Medical Devices
21 CFR Part 820	Quality System Regulation
21 CFR Part 822	Postmarket Surveillance

Investigational Device Exemptions (IDE), New Drug Application (NDA), Institutional Review Board (IRB), Food and Drug Administration (FDA)