General Session: FDA Clinical Research Compliance for Medical Devices: A Primer
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Neil O'Flaharty, Partner, Amin Talati Wasserman LLP.
June 16, 2021
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When does research of a medical device become subject to FDA oversight?
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What are the key considerations for running a medical device clinical study in compliance with FDA requirements?
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Strategies for avoiding non-compliant clinical research and running FDA-compliant studies
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