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