Chapter 22-B109 - INVESTIGATIONAL DEVICE EXEMPTIONS
- Rule 22-B10900 - SCOPE
- Rule 22-B10901 - APPLICABILITY
- Rule 22-B10902 - LABELING OF INVESTIGATIONAL DEVICES
- Rule 22-B10903 - PROHIBITION OF PROMOTION AND OTHER PRACTICES
- Rule 22-B10904 - WAIVERS
- Rule 22-B10905 - IMPORT AND EXPORT REQUIREMENTS
- Rule 22-B10906 - ADDRESS FOR INVESTIGATIONAL DEVICE EXEMPTION CORRESPONDENCE
- Rule 22-B10907 - APPLICATION
- Rule 22-B10908 - INVESTIGATIONAL PLAN
- Rule 22-B10909 - REPORT OF PRIOR INVESTIGATIONS
- Rule 22-B10910 - DEPARTMENT OF HEALTH ACTION ON APPLICATIONS
- Rule 22-B10911 - SUPPLEMENTAL APPLICATIONS
- Rule 22-B10912 - TREATMENT USE OF AN INVESTIGATIONAL DEVICE
- Rule 22-B10913 - CONFIDENTIALITY OF DATA AND INFORMATION
- Rule 22-B10914 - GENERAL RESPONSIBILITIES OF SPONSORS
- Rule 22-B10915 - DEPARTMENT OF HEALTH AND INSTITUTIONAL REVIEW BOARD APPROVAL
- Rule 22-B10916 - SELECTING INVESTIGATORS AND MONITORS
- Rule 22-B10917 - INFORMING INVESTIGATORS
- Rule 22-B10918 - MONITORING INVESTIGATIONS
- Rule 22-B10919 - EMERGENCY RESEARCH
- Rule 22-B10920 - INSTITUTIONAL REVIEW BOARD COMPOSITION, DUTIES, AND FUNCTIONS
- Rule 22-B10921 - INSTITUTIONAL REVIEW BOARD APPROVAL
- Rule 22-B10922 - INSTITUTIONAL REVIEW BOARD'S CONTINUING REVIEW
- Rule 22-B10923 - SIGNIFICANT RISK DEVICE DETERMINATIONS
- Rule 22-B10924 - GENERAL RESPONSIBILITIES OF INVESTIGATORS
- Rule 22-B10925 - SPECIFIC RESPONSIBILITIES OF INVESTIGATORS
- Rule 22-B10926 - DISQUALIFICATION OF A CLINICAL INVESTIGATOR
- Rule 22-B10927 - RECORDS
- Rule 22-B10928 - INSPECTIONS
- Rule 22-B10929 - REPORTS
- Rule 22-B10999 - DEFINITIONS