Inspections, Compliance, Enforcement, and Criminal Investigations
PART I - BACKGROUND
Since the Investigational New Drug (IND) Regulations went into effect in 1963, the Food and Drug Administration (FDA) has exercised oversight of the conduct of clinical studies involving FDA regulated products. The BIMO Program was established in 1977 by a task force that included representatives from the drug, biologic, device, animal drug, and food areas.
Compliance programs (CP) were developed to provide uniform guidance and specific instructions for inspections of Clinical Investigators (CP 7348.811), Sponsors (CP 7348.810), In-Vivo Bioequivalence facilities (CP 7348.001), Institutional Review Boards (CP 7348.809), and Non-Clinical Laboratories (CP 7348.808).
Regulations addressing requirements of clinical investigators, sponsors and monitors (21 CFR Parts 312, 314, 511, and 514) were published on March 19, 1987, and became effective on June 17, 1987. Regulations for clinical investigations of devices (21 CFR Part 812) became effective January 18, 1980, and for premarket approval of medical devices (21 CFR Part 814) on July 22, 1986.