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FDA Issues Draft Guidance Related to Marketing Submissions for AI/ML-Enabled DSFs, and Final Guidance Describing the FDA's Adoption of Section 524B "Ensuring Cybersecurity of Devices" | Wilson Sonsini Goodrich & Rosati

The U.S. Food and Drug Administration (FDA) is continuing its effort to provide industries with updated guidance for digital health technologies. On April 3, 2023, the FDA released...
Wilson Sonsini Goodrich Rosati Drug Administration Device Software Functions Wilson Sonsini Goodrich Submission Recommendations Predetermined Change Control Plan

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