Speaker Profile

Robert F. Munzner

Medical Device Consultant,

Robert Munzner was employed in the FDA Office of Device Evaluation for more than twenty years. As Chief of the Neurological Devices Branch he reviewed and supervised the review of IDE, PMA and 510(k) applications. He also served as Acting Director of the Division of Anesthesiology, Neurology, and Radiology Devices. He has written numerous articles concerning medical devices regulation, including a column in the IEEE Engineering in Medicine and Biology Magazine. He earned a Ph.D. in Biomedical Engineering at the University of Virginia and is Post-Doctoral Fellow of The Johns Hopkins School of Medicine. He presently serves as a consultant to medical device developers seeking advice concerning FDA premarket procedures.

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Obtaining an FDA Investigational Device Exemption

Clinical testing and studies of effectiveness are often needed to demonstrate that new medical devices are reasonably safe and effective. The participation of human subjects in these studies often implies some degree of risk and outcomes which are necessarily unpredictable. It is essential, therefore, that the rights, safety, and welfare of the subjects be protected. The instrument by which this is accomplished is the Investigational Device Exemption (IDE).

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