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Ann Thorac Surg 2006;82:773-775
© 2006 The Society of Thoracic Surgeons

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Editorial

FDA Perspective on Clinical Trial Design for Cardiovascular Devices

Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Rockville, Maryland

^_* Address correspondence to Mr Chen, Food and Drug Administration Center for Devices and Radiological Health, Office of Device Evaluation, 9200 Corporate Blvd, HFX-450, Rockville, MD 20850 (Email: eric.chen@fda.hhs.gov).

The first 300 words of the full text of this article appear below.

	Introduction

 
The papers by Parides and colleagues [1] and Grunkemeier and colleagues [2] in this issue of The Annals address the challenge of designing clinical trials for heart valves and mechanical circulatory support devices (MCSD). As discussed in these two papers, study designs range from randomized controlled trials to single-arm studies measured against Objective Performance Criteria (OPC). This editorial describes aspects of clinical trial design that the Food and Drug Administration (FDA) believes necessary to provide the scientifically valid data for regulation of heart valve prostheses and MCSDs.

	Regulatory Issues

 
The 1976 Medical Devices Amendment of the Food, Drug, and Cosmetic Act mandated that the FDA regulate market approval of new medical devices based on scientific evidence that there is reasonable assurance that the device is both safe and effective. This data must specify indications for use and the intended patient population as determined by the risk/benefit ratio [3]. It should be noted that the FDA is limited to regulating manufacturers and devices and prevented from any such regulation of practioners or practice of medicine by the FDA Modernization Act of 1997 [4].

The FDA provides three paths whereby medical devices can achieve market access: Demonstration of Substantial Equivalence to a "Pre-Amendment Device" product [510(k)], by Pre-Market Approval, and Humanitarian Device Exemption. For devices that present the highest level of risk to the patient in event of failure, the stringent requirements of a Pre-Market Approval process are generally necessary. A Humanitarian Device Exemption reduces the level of benefit that must be demonstrated to permit use in a clearly defined plausible patient subset of no more than 4,000 patients annually. These regulatory processes differ from those for European Union device regulation where, except in the highest risk device category, self-certification by the manufacturer that devices meet . . . [Full Text of this Article]

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Ann. Thorac. Surg. 2006 82: 1140-1146. [Abstract] [Full Text] [PDF]