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FDA Issues Draft Guidance for Software Contained in Medical Devices

On November 3, 2021 the FDA issued draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The final version will eventually replace the FDA’s “Guidance for the Content of Premarket Submissions...more

11/10/2021  /  Digital Health , Draft Guidance , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Medical Software , Pharmaceutical Industry , Premarket Approval Applications
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