21 C.F.R. PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS
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
