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Software › Regulatory Requirements › Federal Food Drug and Cosmetic Act (FFDCA)

King & Spalding

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

King & Spalding on

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

Mintz - Health Care Viewpoints

Things to Consider When Determining the Regulatory Requirements for Software (Hint: It’s More Than the Device Classification)

Mintz - Health Care Viewpoints on

The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many companies, both existing and start-up, are...more

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