Area · current view
FDA
Digital health, SaMD, AI/ML device guidance · 11 briefs
The curated "state of play" briefing for each area is a
SignalHealth Pro feature. Below is the area's brief history.
Current & historical briefs
Jul 30, 2026
FDA, EU, and Korea Align AI Medical Device Cybersecurity Goals but Differ in Implementation
Notable
Jul 17, 2026 · open for comment
FDA Proposes Renewal of Information Collection for Infant Formula Reporting and LabelingJul 14, 2026 · open for comment
FDA Seeks Input on Safe Administration Training for Future Psychedelic TherapiesJul 13, 2026 · open for comment
FDA Proposes Rules for Distributed Manufacturing Registration and Foreign Establishment AlignmentJul 1, 2026 · open for comment
HHS Updates Industry on AI RFI Findings, Signals Coordinated Push to Embed AI in Clinical CareJun 29, 2026 · open for comment
FDA Proposes Extending Tobacco Product Establishment Registration and Listing to Foreign Owners and OperatorsJun 25, 2026
CISA Advisory: OHIF DICOM Viewer ≤v3.12.0 Has Critical SSRF Flaw Enabling Clinician Token Theft
Notable