Area · current view
FDA
Digital health, SaMD, AI/ML device guidance · 22 briefs
Current & historical briefs
Aug 31, 2026 · open for comment
FDA Seeks Comment on Proposed Information Collection for Medical Device Removals and Corrections ReportingAug 17, 2026 · open for comment
FDA Proposes New Information Collection for Investigational New Drug Application RequirementsAug 17, 2026 · open for comment
FDA Proposes Downgrading Bladder Cancer Detection Endoscopes from Class III to Class IIAug 17, 2026 · open for comment
FDA proposes Class I classification for specific medical device accessories under FDARAAug 10, 2026 · open for comment
FDA Proposes Reclassifying Digital Breast Tomosynthesis Systems from Class III to Class IIJul 30, 2026
FDA, EU, and Korea Align AI Medical Device Cybersecurity Goals but Differ in ImplementationJul 17, 2026 · open for comment
FDA Seeks Public Comment on Accreditation Scheme for Conformity Assessment ProgramJul 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