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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 812 - Investigational Device Exemptions |
| Subpart A - General Provisions |
| § 812.1 - Scope. |
| § 812.2 - Applicability. |
| § 812.3 - Definitions. |
| § 812.5 - Labeling of investigational devices. |
| § 812.7 - Prohibition of promotion and other practices. |
| § 812.10 - Waivers. |
| § 812.18 - Import and export requirements. |
| § 812.19 - Address for IDE correspondence. |
| Subpart B - Application and Administrative Action |
| § 812.20 - Application. |
| § 812.25 - Investigational plan. |
| § 812.27 - Report of prior investigations. |
| § 812.28 - xxx |
| § 812.30 - FDA action on applications. |
| § 812.35 - Supplemental applications. |
| § 812.36 - Treatment use of an investigational device. |
| § 812.38 - Confidentiality of data and information. |
| Subpart C - Responsibilities of Sponsors |
| § 812.40 - General responsibilities of sponsors. |
| § 812.42 - FDA and IRB approval. |
| § 812.43 - Selecting investigators and monitors. |
| § 812.45 - Informing investigators. |
| § 812.46 - Monitoring investigations. |
| § 812.47 - Emergency research under § 50.24 of this chapter. |
| Subpart D - IRB Review and Approval |
| § 812.60 - IRB composition, duties, and functions. |
| § 812.62 - IRB approval. |
| § 812.64 - IRB's continuing review. |
| § 812.65 - [Reserved] |
| § 812.66 - Significant risk device determinations. |
| Subpart E - Responsibilities of Investigators |
| § 812.100 - General responsibilities of investigators. |
| § 812.110 - Specific responsibilities of investigators. |
| § 812.119 - Disqualification of a clinical investigator. |
| Subpart F - XXX |
| Subpart G - Records and Reports |
| § 812.140 - Records. |
| § 812.145 - Inspections. |
| § 812.150 - Reports. |