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Home Page > Executive Branch > Code of Federal Regulations > Electronic Code of Federal Regulations
e-CFR Data is current as of November 19, 2009
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS
Subpart A--GENERAL PROVISIONS
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| Labeling of investigational devices. |
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| Prohibition of promotion and other practices. |
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| Import and export requirements. |
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| Address for IDE correspondence. |
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Subpart B--APPLICATION AND ADMINISTRATIVE ACTION
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| Report of prior investigations. |
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| FDA action on applications. |
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| Supplemental applications. |
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| Treatment use of an investigational device. |
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| Confidentiality of data and information. |
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Subpart C--RESPONSIBILITIES OF SPONSORS
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| General responsibilities of sponsors. |
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| Selecting investigators and monitors. |
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| Monitoring investigations. |
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| Emergency research under 50.24 of this chapter. |
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Subpart D--IRB REVIEW AND APPROVAL
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| IRB composition, duties, and functions. |
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| Significant risk device determinations. |
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Subpart E--RESPONSIBILITIES OF INVESTIGATORS
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| General responsibilities of investigators. |
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| Specific responsibilities of investigators. |
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| Disqualification of a clinical investigator. |
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Subpart F--[RESERVED]
Subpart G--RECORDS AND REPORTS
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