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U.S. Department of Health and Human Services

Medical Devices

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Final Guidance - Design Considerations For Pivotal Clinical Investigations For Medical Devices

November 6, 2013

Today the Food and Drug Administration (FDA) released a final guidance document, Design Considerations for Pivotal Clinical Investigations for Medical Devices. This is the first time the FDA is providing guidance containing specific examples of pivotal clinical study designs and principles to guide medical device manufacturers in the selection of a particular design.

The final guidance is intended to improve the quality and increase the likelihood of success of pivotal clinical trials so the data obtained through these studies supports the safety and effectiveness of a device, thereby reducing the need for FDA staff to request additional data when a device application is undergoing FDA review. Improving the quality of data obtained through pivotal studies will lead to timelier FDA approval or clearance of premarket submissions, and speed U.S. patient access to new devices.

This final guidance clarifies the FDA's thinking on important premarket clinical study design issues and outlines principles and techniques for developing higher quality studies. It also complements existing guidance on clinical studies by providing specific examples of different study designs, relevant principles to apply in the choice of study design and techniques for sustaining the quality of clinical studies.

If you have any questions regarding this guidance, please contact please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) in the Center for Devices and Radiological Health (FDA) at 1-800-638-2041, 301-796-7100 or dsmica@fda.hhs.gov

Thank you for your continued support of the FDA and its mission.

Food and Drug Administration
Center for Devices and Radiological Health