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Journal of Long-Term Effects of Medical Implants

ISSN Print: 1050-6934
ISSN Online: 1940-4379

Journal of Long-Term Effects of Medical Implants

DOI: 10.1615/JLongTermEffMedImplants.v19.i3.20
pages 173-183

New Orthopedic Devices and the FDA

Ujash Sheth
Queen's School of Medicine, Queen's University, Kingston; and Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada
Nhu-An Nguyen
Ohio University College of Osteopathic Medicine, Athens, OH, US
Sean Gaines
Ohio University College of Osteopathic Medicine, Athens, OH, US
Mohit Bhandari
CLARITY Research Group, McMaster University, Department of Orthopedic Surgery Musculoskeletal Research Unit, Canada and Division of Orthopaedic Surgery and Department of Clinical Epidemiology & Biostatistics, Hamilton General Hospital, Canada
Charles T. Mehlman
Cincinnati Children's Hospital, Division of Pediatric Orthopaedic Surgery, Cincinnati, OH, USA
Guy Klein
University Hospitals, Department of Orthopaedic Surgery, Richmond Heights, OH, USA

ABSTRACT

Each year the field of orthopedics is introduced to an influx of new medical devices. Each of these medical devices has faced certain hurdles prior to being approved for marketing by the U.S. Food and Drug Administration (FDA). Among the regulatory pathways available, the 510(k) premarket notification is by far the one most commonly used. The 510(k) premarket notification allows the manufacturer to receive prompt approval of their device by demonstrating that it is "substantially equivalent" to an existing legally marketed device. In most instances, this proof of substantial equivalence allows manufacturers of medical devices to bypass the use of clinical trials, which are a hallmark of the approval process for new drugs. As a result, most medical devices are approved without demonstrating safety or effectiveness. This article reviews the regulatory processes used by the FDA to evaluate new orthopedic devices.