Chapter 22-B109. INVESTIGATIONAL DEVICE EXEMPTIONS


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