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(Circulation. 2000;101:e9042.)
© 2000 American Heart Association, Inc.

Cardiovascular News

First Food and Drug Administration Approval Under Humanitarian Device Exemption of a Septal Occluder for Fenestrated Fontan and Muscular Ventricular Septal Defects

Carlos E. Ruiz, MD, PhD; E. H. Austin, III, MD; J. P. Cheatham, MD; D. A. Danford, MD; L. A. Latson, MD; J. Mayer, MD; C. E. Mullins, MD; S. Sanders, MD

From the Department of Pediatric Interventional Cardiology, Rush-Presbyterian–St. Luke’s Medical Center, Chicago, Ill.

Correspondence to Carlos E. Ruiz, MD, PhD, Department of Pediatric Interventional Cardiology, Rush-Presbyterian–St. Luke’s Medical Center, 1653 West Congress Parkway, Room 736MU, Chicago, IL 60612-3833.

The difficult process of obtaining Food and Drug Administration (FDA) approval for pediatric-specific devices and drugs is one of the most important issues confronting Pediatric Cardiology (and Pediatrics in general). It has forced our profession to continually administer drugs and implant devices "off-label" (for purposes and age groups other than those for which they were tested and approved). Consequently, it is possible that important risk factors in the pediatric population, which has far different dispositions than the adult population, may be overlooked. This problem has deteriorated further as the pace of technological change has continued to accelerate and our ability to distribute clinical results has improved.

Accordingly, a group from the Society for Cardiac Angiography and Interventions, Pediatric Section, together with representatives from the American Heart Association, the American College of Cardiology, the American Academy of Pediatrics, the Society of Thoracic Surgeons, and the American Association of Thoracic Surgeons, is working with the FDA to find a solution for this critical problem. This group has met several times and has proposed the formulation of "objective performance criteria." These will be the minimum standard criteria required to establish the safety of any pediatric product for FDA approval. Because Pediatric Interventional Cardiologists deal with a smaller volume of patients with a broader spectrum of disease than our Adult Cardiology colleagues, our ability to use the same study designs and outcome measures as trials in adult patients is restricted. The research and development costs for manufacturers of pediatric products may exceed market returns . . . [Full Text of this Article]