Area · current view
FDA
Digital health, SaMD, AI/ML device guidance · 48 briefs
Current & historical briefs
Oct 19, 2026
Critical Vulnerabilities in J4Care dcm4chee-arc-light Allow Data Deletion and Denial-of-ServiceOct 28, 2026 · open for comment
FDA Seeks Comment on Electronic Records and Signatures Collection Under PRAOct 20, 2026
FDA’s Digital Health Center Director Says GenAI Tools Should Be Evaluated Like PhysiciansOct 19, 2026
SMART Health IT Urges FDA to Mandate FHIR-Based Data Interfaces for Generative AI Medical DevicesOct 12, 2026 · open for comment
FDA Issues Draft Guidance on Pre-Market Testing for Surgical Robot SystemsOct 8, 2026 · open for comment
FDA Seeks OMB Clearance for Medical Device Adverse Event Reporting Program (MedSun)Oct 6, 2026 · open for comment
FDA Requests Input on Ibogaine Clinical Trial Design for Opioid Use Disorder and PTSDSep 29, 2026 · open for comment
FDA Proposes Information Collection for Tracking Medical DevicesSep 25, 2026 · open for comment
FDA seeks public input on Biosimilar User Fee Act reauthorization for FY 2028-2032Sep 25, 2026 · open for comment
FDA Issues Draft Guidance on Premarket Submissions for Robotically-Assisted Surgical DevicesSep 24, 2026 · open for comment
HHS Seeks Input on Regulating Deceased Donor Islet Cells for Type 1 Diabetes TreatmentSep 22, 2026 · open for comment
FDA proposes substituting "animal" with "nonclinical" in testing terminologySep 16, 2026
FDA Announces Microbiology Devices Panel Meeting on Pathogen-Agnostic Sequencing for Emergency PreparednessSep 15, 2026 · open for comment
FDA Seeks Public Input on Statistical Design of Rare Disease Clinical TrialsSep 11, 2026 · open for comment
FDA Seeks Feedback on Potential Regulation of Generative AI Medical DevicesSep 11, 2026 · open for comment
FDA Seeks Comment on Proposed Medical Device Tracking Information CollectionSep 9, 2026 · open for comment
FDA Determines Regulatory Review Period for Andembry to Support Patent ExtensionSep 9, 2026 · open for comment
FDA Seeks Public Comment on Pregnancy Exposure Registry Survey of Healthcare ProvidersSep 9, 2026 · open for comment
FDA Seeks Public Comment on Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) RegulationAug 31, 2026 · open for comment
FDA Seeks Comment on Proposed Information Collection for Medical Device Removals and Corrections ReportingAug 26, 2026 · open for comment
FDA seeks public comment on proposed information collection for allegations of regulatory misconduct submitted to CDRHAug 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 11, 2026 · open for comment
FDA Proposes Mandatory GRAS Notice Submission for Food SubstancesAug 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