FDA-SOFTWARE GUIDANC › Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

FDA-SOFTWARE GUIDANC - 2023 EDITION - CURRENT
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Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices


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Document Number

FDA-SOFTWARE GUIDANC

Revision Level

2023 EDITION

Status

Current

Publication Date

June 14, 2023

Page Count

45 pages