Title 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

TEXT PDF812.1 Scope.
TEXT PDF812.2 Applicability.
TEXT PDF812.3 Definitions.
TEXT PDF812.5 Labeling of investigational devices.
TEXT PDF812.7 Prohibition of promotion and other practices.
TEXT PDF812.10 Waivers.
TEXT PDF812.18 Import and export requirements.
TEXT PDF812.19 Address for IDE correspondence.
TEXT PDF812.20 Application.
TEXT PDF812.25 Investigational plan.
TEXT PDF812.27 Report of prior investigations.
TEXT PDF812.30 FDA action on applications.
TEXT PDF812.35 Supplemental applications.
TEXT PDF812.36 Treatment use of an investigational device.
TEXT PDF812.38 Confidentiality of data and information.
TEXT PDF812.40 General responsibilities of sponsors.
TEXT PDF812.42 FDA and IRB approval.
TEXT PDF812.43 Selecting investigators and monitors.
TEXT PDF812.45 Informing investigators.
TEXT PDF812.46 Monitoring investigations.
TEXT PDF812.47 Emergency research under 50.24 of this chapter.
TEXT PDF812.60 IRB composition, duties, and functions.
TEXT PDF812.62 IRB approval.
TEXT PDF812.64 IRB's continuing review.
TEXT PDF812.66 Significant risk device determinations.
TEXT PDF812.100 General responsibilities of investigators.
TEXT PDF812.110 Specific responsibilities of investigators.
TEXT PDF812.119 Disqualification of a clinical investigator.
TEXT PDF812.140 Records.
TEXT PDF812.145 Inspections.
TEXT PDF812.150 Reports.

--------------------------------------------------------------------- -----------

[BACK ][BACK ]