Chapter: 22-B109
INVESTIGATIONAL DEVICE EXEMPTIONS  (Rename History)

Title: 22 HEALTH
SubTitle: 22-B PUBLIC HEALTH AND MEDICINE


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Section Number Section Heading Latest Version Effective Date
22-B10900 SCOPE View text 7/12/2013
22-B10901 APPLICABILITY View text 7/12/2013
22-B10902 LABELING OF INVESTIGATIONAL DEVICES View text 7/12/2013
22-B10903 PROHIBITION OF PROMOTION AND OTHER PRACTICES View text 7/12/2013
22-B10904 WAIVERS View text 7/12/2013
22-B10905 IMPORT AND EXPORT REQUIREMENTS View text 7/12/2013
22-B10906 ADDRESS FOR INVESTIGATIONAL DEVICE EXEMPTION CORRESPONDENCE View text 7/12/2013
22-B10907 APPLICATION View text 7/12/2013
22-B10908 INVESTIGATIONAL PLAN View text 7/12/2013
22-B10909 REPORT OF PRIOR INVESTIGATIONS View text 7/12/2013
22-B10910 DEPARTMENT OF HEALTH ACTION ON APPLICATIONS View text 7/12/2013
22-B10911 SUPPLEMENTAL APPLICATIONS View text 7/12/2013
22-B10912 TREATMENT USE OF AN INVESTIGATIONAL DEVICE View text 7/12/2013
22-B10913 CONFIDENTIALITY OF DATA AND INFORMATION View text 7/12/2013
22-B10914 GENERAL RESPONSIBILITIES OF SPONSORS View text 7/12/2013
22-B10915 DEPARTMENT OF HEALTH AND INSTITUTIONAL REVIEW BOARD APPROVAL View text 7/12/2013
22-B10916 SELECTING INVESTIGATORS AND MONITORS View text 7/12/2013
22-B10917 INFORMING INVESTIGATORS View text 7/12/2013
22-B10918 MONITORING INVESTIGATIONS View text 7/12/2013
22-B10919 EMERGENCY RESEARCH View text 7/12/2013
22-B10920 INSTITUTIONAL REVIEW BOARD COMPOSITION, DUTIES, AND FUNCTIONS View text 7/12/2013
22-B10921 INSTITUTIONAL REVIEW BOARD APPROVAL View text 7/12/2013
22-B10922 INSTITUTIONAL REVIEW BOARD'S CONTINUING REVIEW View text 7/12/2013
22-B10923 SIGNIFICANT RISK DEVICE DETERMINATIONS View text 7/12/2013
22-B10924 GENERAL RESPONSIBILITIES OF INVESTIGATORS View text 7/12/2013
22-B10925 SPECIFIC RESPONSIBILITIES OF INVESTIGATORS View text 7/12/2013
22-B10926 DISQUALIFICATION OF A CLINICAL INVESTIGATOR View text 7/12/2013
22-B10927 RECORDS View text 7/12/2013
22-B10928 INSPECTIONS View text 7/12/2013
22-B10929 REPORTS View text 7/12/2013
22-B10999 DEFINITIONS View text 7/12/2013