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(Stroke. 2005;36:404.)
© 2005 American Heart Association, Inc.

Emerging Therapies

The Food and Drug Administration Medical Device Review Process

Clearance of a Clot Retriever for Use in Ischemic Stroke

Richard P. Felten, MS; Neil R.P. Ogden, MS; Carlos Peña, PhD; Miriam C. Provost, PhD; Michael J. Schlosser, MD Celia M. Witten, PhD, MD

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.

Correspondence to Dr C.M. Witten, 9200 Corporate Blvd, HFZ-410, Food and Drug Administration, Rockville, MD 20815. E-mail cmw@cdrh.fda.gov

Section Editors: Marc Fisher MD Antoni Dávalos MD

Key Words: acute care • stroke, ischemic

An extract of the first 250 words of the full text is provided, because this article has no abstract.

	Introduction

 
The Food and Drug Administration (FDA) is responsible 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 advancing public health by helping to speed innovations that make treatments more effective, safer, and more affordable. The Center for Devices and Radiological Health (CDRH) in the FDA is responsible for premarket and postmarket regulation of medical devices. On August 11, 2004 the FDA gave market authorization to the first medical device specifically indicated to retrieve blood clots from the brain in ischemic stroke for patients who fail or are ineligible for intravenous tissue plasminogen activator (tPA). This article summarizes the FDA regulatory process for marketing medical devices in general and provides background on the FDA clearance of a clot retriever for ischemic stroke.

	FDA Medical Device Regulations

 
There are several types of marketing applications that a medical device manufacturer may submit to CDRH. Most medical devices reach the market through either the premarket approval (PMA) process or the premarket notification process (510(k). In fiscal year 2003, the FDA gave market authorization to 4132 devices through the 510(k) program and 31 devices through the PMA program.

Medical device manufacturers submit PMAs for novel devices, also referred to as Class III. These devices tend to be higher risk or raise new types of safety and effectiveness questions that must be answered before approval for marketing. Data in a PMA application must demonstrate a "reasonable assurance" of safety and effectiveness. Manufacturers submit 510(k)s . . . [Full Text of this Article]

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