Final Guidance for Submission of Off-The-Shelf Software in Medical Devices
Final Guidance for Submission of Off-The-Shelf Software in Medical Devices On August 11, the FDA released the Final Guidance Off-the-Shelf Software Use in Medical Devices. The document, which supersedes Off-The-Shelf Software Use in Medical Devices issued September 27, 2019, provides information on recommended documentation sponsors should include in a premarket submission for FDA’s evaluation …
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