What is involved in a regulatory trial investigating a new medical device?

Journal of long-term effects of medical implants

PubMedID: 18540859

McKay PJ, Resendes S, Schemitsch E, Bhandari M. What is involved in a regulatory trial investigating a new medical device?. J Long Term Eff Med Implants. 2008;17(2):165-71.
Regulatory trials allow for the clinical evaluation of new drugs and medical devices, determining whether or not they can be safely and effectively used in patient care. The outcome of these trials may result in new and better ways of preventing, diagnosing, and treating illness. However, conducting a regulatory trial to evaluate a new medical device is a complex and time-intensive process involving many parties. This paper will provide an overview of the regulatory approval process for medical devices in the United States and will discuss what is involved in conducting a regulatory trial investigating a new device.