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Navigating the intricacies of medical device clinical research compliance: A primer

Neil F. O’Flaherty (neil@amintalati.com) is a Partner at Amin Talati Wasserman LLP in the firm’s Chicago office, and Javier O. Gonzalez-Rivera (jog15@georgetown.edu) is a former Associate Attorney in the firm’s Washington, DC, office.

The U.S. Food and Drug Administration (FDA) regulation of medical devices is quite complex. With the evolution and emergence of newer technologies, determining how these devices will be regulated and navigating the regulatory pathways are difficult tasks. In addition, during the past decades, the number and complexity of clinical trials have grown dramatically. These changes have created new challenges to clinical trial oversight. Effective monitoring of clinical investigations by sponsors is critical to the protection of human subjects and the conduct of high-quality studies. Protecting the rights, safety, and welfare of people who participate in clinical research is a critical aspect of the FDA’s mission. In this article, we provide a top-level discussion on the basics of medical device clinical research compliance.

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