From: Subject: 1999 CFR Title 24, Volume 2 Date: Tue, 7 Nov 2006 17:25:58 -0500 MIME-Version: 1.0 Content-Type: multipart/related; boundary="----=_NextPart_000_0000_01C70291.C9D80740"; type="text/html" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2800.1807 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C70291.C9D80740 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.access.gpo.gov/nara/cfr/waisidx_99/21cfr812_99.html 1999 CFR Title 24, Volume 2

Title 21--Food and = Drugs

CHAPTER I--FOOD AND DRUG = ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

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.
812.20 Application.
812.25 Investigational plan.
812.27 Report of prior investigations.
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.
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.
812.60 IRB composition, duties, and functions.
812.62 IRB approval.
812.64 IRB's continuing review.
812.66 Significant risk device determinations.
812.100 General responsibilities of investigators.
812.110 Specific responsibilities of investigators.
812.119 Disqualification of a clinical investigator.
812.140 Records.
812.145 Inspections.
812.150 Reports.

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