Premarket Assessment of Pediatric Medical Devices: Guidancwe Industry and Food and Drug Administration Staff.

摘要

FDA reviews pediatric devices through all of its premarket pathways, including premarket notification (510(k)), premarket approval (PMA), biological license application (BLA), and humanitarian device exemption (HDE). A manufacturer may show substantial equivalence to a predicate device, or may seek marketing approval by demonstrating with reasonable assurance that the device is safe and effective for its intended use. Clinical evaluation may be needed to support marketing of a device indicated for pediatric use. If such studies are needed, they should be conducted in accordance with the investigational device exemptions (IDE) regulation (21 CFR Part 812). FDA has jurisdiction over significant risk studies, whereas Institutional Review Boards (IRBs) have oversight responsibility for non-significant risk studies.