Nathan Beaton

Nathan Beaton

Latham & Watkins LLP

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FDA Announces Planned Changes to the 510(k) Premarket Notification Program

Agency signals forthcoming changes that could impact manufacturers’ ability to commercialize new medical devices. Background - On November 26, 2018, officials from the Food and Drug Administration (FDA or the Agency)...more

12/3/2018  /  510(k) RTA , FDA De Novo Clearance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Regulatory Agenda
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