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FDA Proposes Guidelines That Clarify Benefit-Risk Determinations for Medical Devices
Date:8/15/2011

dance aims to provide more clarity to manufacturers about what factors we consider when making an approval decision."  

The guidance also proposes that medical device reviewers use a worksheet to document how they make benefit-risk determinations. In certain cases, this document could be made public post-approval, making the FDA's decision making process even more transparent.

For more information:

Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm267829.htm

FDA: Medical Devices

http://www.fda.gov/MedicalDevices/default.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Consumer Inquiries: 888-INFO-FDA


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SOURCE U.S. Food and Drug Administration
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