July 11, 2025
FDA Publishes More Than 200 Complete Response Letters (CRLs) With More to Come
May 19, 2025
FDA Announces Completion of AI-Assisted Scientific Review Pilot and Deployment of Agency-Wide AI-Assisted Review
May 1, 2025
FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions
January 10, 2025
FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions
December 8, 2022
HHS Office for Civil Rights Issues Guidance Regarding HIPAA Requirements for Online Tracking Technologies