Overview of Medical Device Law and Regulation
Learn the statutory framework and major statutory underpinnings for medical device regulation. Discuss the federal agencies that play a role in regulating medical devices. Address the state role in regulation.
McKenzie E. Cato, Associate, Hyman, Phelps & McNamara, P.C.
This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in October 2023.
MCKENZIE E. CATO is an associate at Hyman, Phelps & McNamara, P.C. She assists clients with pre- and post-market FDA regulatory topics, including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, and reviewing advertising and promotional materials. In the premarket area, Ms. Cato prepares IDEs, 510(k)s, de novos, and PMAs. She also prepares pre-submissions, and assists clients in preparing for and represents clients at pre-submission meetings with FDA. In the postmarket area, she advises clients on complaint handling, MDRs, field actions, and QSR compliance. Ms. Cato joined the firm in 2012 and worked as a Legal Assistant and Law Clerk for six years prior to becoming an Associate. She graduated with honors from the George Washington University Law School. While in law school, Ms. Cato was a member of the George Washington Law Review and the Moot Court Board.Get Access
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