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D.C. Mun. Regs. tit. 22-B, ch. 109 – Investigational Device Exemptions | Midpage
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District of Columbia Municipal Regulations
Title 22
22-B
Chapter 22-B109
D.C. Mun. Regs. tit. 22-B, ch. 109
Investigational Device Exemptions
District of Columbia, Office of the Secretary
22-B10900
Scope
22-B10901
Applicability
22-B10902
Labeling of Investigational Devices
22-B10903
Prohibition of Promotion and Other Practices
22-B10904
Waivers
22-B10905
Import and Export Requirements
22-B10906
Address for Investigational Device Exemption Correspondence
22-B10907
Application
22-B10908
Investigational Plan
22-B10909
Report of Prior Investigations
22-B10910
Department of Health Action on Applications
22-B10911
Supplemental Applications
22-B10912
Treatment Use of an Investigational Device
22-B10913
Confidentiality of Data and Information
22-B10914
General Responsibilities of Sponsors
22-B10915
Department of Health and Institutional Review Board Approval
22-B10916
Selecting Investigators and Monitors
22-B10917
Informing Investigators
22-B10918
Monitoring Investigations
22-B10919
Emergency Research
22-B10920
Institutional Review Board Composition, Duties, and Functions
22-B10921
Institutional Review Board Approval
22-B10922
Institutional Review Board's Continuing Review
22-B10923
Significant Risk Device Determinations
22-B10924
General Responsibilities of Investigators
22-B10925
Specific Responsibilities of Investigators
22-B10926
Disqualification of a Clinical Investigator
22-B10927
Records
22-B10928
Inspections
22-B10929
Reports
22-B10999
Definitions