The role of clinical trials in the food and drug administration approval process for cardiovascular devices

Abstract

An innovative medical device industry has been pivotal in the phenomenal impact of technology on health care, and its vitality is critical to continued progress in this field. The Office of Device Evaluation is aware of the deleterious impact that delays in approval can have on both industry and health care. 'Off-shore' device production and clinical studies are subject to the same FDA regulatory scrutiny for marketing approval in the United States. Indeed, many overseas jurisdictions have adopted FDA regulations separately or as part of the International Standards Organization recommendations. Although clinical studies performed outside the United States may be acceptable, the agency requires the study cohort for a device trial to demographically approximate the targeted US population. The agency solicits input from all interested parties in developing guidance for the review process. Guidance is generated in consultative interaction among device sponsor, clinical investigators, the regulatory agency, and other interested parties. This cooperation ensures a dynamic review process capable of keeping pace with changes in the field.