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FDA Seeks Comment on Proposed Guidelines for High-Quality Clinical Studies
Date:8/15/2011

this guidance is developed primarily for clinical studies used to support PMAs, the recommendations of this guidance may also be used in designing clinical studies used to support 510(k) submissions.

For more information:

CDRH Plan of Action for 510(k) and Science

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htm

Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff: Design Considerations for Pivotal Clinical Investigations for Medical Devices http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm265553.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.

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


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SOURCE U.S. Food and Drug Administration
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