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) and the Center for Devices and Radiological Health (CDRH) announced a series of forthcoming steps FDA intends to take to modernize the premarket notification pathway under Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FDCA) (the 510(k) program). In its announcement, FDA also flagged that it plans to propose new regulations clarifying procedures and requirements for submissions under the de novo pathway.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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