Area · current view
FDA
Digital health, SaMD, AI/ML device guidance · 14 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
Aug 10, 2026 · open for comment
FDA Proposes Reclassifying Digital Breast Tomosynthesis Systems from Class III to Class II
High
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 Seeks Comment on Medical Device Voluntary Improvement Program Information CollectionJul 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