Because No One is Immune to the Law
December 16, 2022 - AI + Robotics, FDA, Regulatory

AI Trends for 2023 - FDA Regulatory

Patenting Artificial Intelligence in the U.S. – Considerations for AI Companies

In September 2022, the U.S. Food & Drug Administration (FDA) released its Clinical Decision Support (CDS) Software Guidance and the final report on the Software Pre-Certification Pilot Program. The new FDA policies move away from prized flexibilities in the previous guidelines governing software products. In the new and final CDS Guidance, FDA modified its interpretation of each of the four criteria in section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act, significantly narrowing what FDA considers exempt from regulatory authority.

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