2023-12723: Content of Premarket Submissions for Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Content of Premarket Submissions for Device Software Functions." This guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket submissions for FDA's evaluation of safety and effectiveness of device software functions, which are functions that meet the definition of a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This document replaces FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, and updates FDA's thinking related to the documentation FDA recommends sponsors include for the review of device software functions in premarket submissions.
The agency’s own summary, as published.
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