FDA Issues Draft Guidance Related to Marketing Submissions for AI/ML-Enabled DSFs, and Final Guidance Describing the FDA's Adoption of Section 524B "Ensuring Cybersecurity of Devices"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