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