On June 14, 2023, FDA finalized its “Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff” (the “2023 Final Guidance”). The ...
Medical apps, treatment planning software, and even firmware for ultrasound devices: software is legally classified as a medical device if it is used for medical purposes. This includes diagnosing, ...
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations ...
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