Published Online
on May 3, 2007

A more recent version of this article appeared on June 1, 2007

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Submitted on September 26, 2006
Revised on November 6, 2006
Accepted on November 14, 2006

An Example of US Food and Drug Administration Device Regulation. Medical Devices Indicated for Use in Acute Ischemic Stroke

Carlos Peña PhD^*; Khan Li MD; Richard Felten MS; Neil Ogden MS; and Mark Melkerson MS

From the Division of General, Restorative, and Neurological Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Md.

^* To whom correspondence should be addressed. E-mail: carlos.pena{at}fda.hhs.gov.

Abstract--The Food and Drug Administration has established requirements for protecting the public health by assuring the safety and effectiveness of a variety of medical products including drugs, devices, and biological products, and for promoting public health by expediting the approval of treatments that are safe and effective. The Center for Devices and Radiological Health is the center within the agency that is responsible for pre- and postmarket regulation of medical devices. In this article, we review current regulation of medical devices, research and development programs, pre- and postmarket perspectives, and future considerations of medical devices, particularly as they relate to devices targeting acute ischemic stroke as an example of the process. We also review the Center for Devices and Radiological Health’s historical perspective of acute ischemic stroke trials and clinical trial design considerations used in prior studies that have led to US market clearance as they are related to currently marketed devices indicated for acute ischemic stroke.

Key words: acute stroke • stroke • treatment

Related Article:

Regulatory Device Approval for Stroke: Fair and Balanced?

Larry B. Goldstein
Stroke 2007 38: 1737-1738. [Extract] [Full Text] [PDF]

This article has been cited by other articles:

				L. B. Goldstein Regulatory Device Approval for Stroke: Fair and Balanced? Stroke, June 1, 2007; 38(6): 1737 - 1738. [Full Text] [PDF]