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