Medical Device User Fee Rates for Fiscal Year 2027
FDA announces medical device user fee rates and payment procedures for FY 2027 (October 1, 2026 – September 30, 2027) under MDUFA V.
US Federal Register - FDA Notices · United StatesUS Federal Register - FDA Notices
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Microbiology Devices Panel: Pathogen-Agnostic Sequencing Advisory Committee Meeting and Public Docket
FDA announces advisory committee meeting and opens public docket to solicit input on pathogen-agnostic sequencing for emergency preparedness and response.
US Federal Register - FDA Notices · United StatesEstablishment of a Quantitative Medicine Innovation Network: Scope, Feasibility, and Opportunities; Request for Information
FDA CDER requests feedback on developing a cross-sector collaborative platform to advance quantitative medicine approaches in drug development and regulatory science.
US Federal Register - FDA Notices · United StatesImproving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information
HHS solicits input on regulatory pathways for deceased donor islet cell therapies for Type 1 diabetes treatment.
US Federal Register - FDA Notices · United StatesFDA Recognized Consensus Standards: Modifications to Recognition List Number 066
FDA announces updates to its list of recognized consensus standards for medical device premarket review and conformity declarations.
US Federal Register - FDA Notices · United StatesDental Composite Resin Devices and Dental Curing Lights—Premarket Notification (510(k)) Submissions Guidances
FDA issues final guidance on 510(k) submission requirements for dental composite resin devices and dental curing lights, superseding 2005 and 2006 guidances.
US Federal Register - FDA Notices · United States
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