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  1. Medical Devices News and Events

CDRH Events

Sponsored or co-sponsored webinars, town halls, meetings, and workshops by the Center for Devices and Radiological Health are listed below.  

For a full list of all FDA meetings visit FDA Meetings, Conferences and Workshops. 

For information about Advisory Committee meetings, visit ​​​​​​Advisory Committees or the Advisory Committee Calendar.

Recent CDRH Events

DateEventEvent Type
11/10/2026FDA and the Focused Ultrasound Foundation Co-sponsored Public Workshop: Research Roundtable on the Development of Transcranial Ultrasound for Neurological and Psychiatric ApplicationsPublic Workshop
10/07/2026Town Hall - Biocompatibility and Toxicological Risk Assessment Town Hall
09/25/2026Public Meeting - Regulatory Science Innovations Catalyzing Medical Device DevelopmentPublic Meeting
09/23/2026Town Hall - Biocompatibility and Chemical Characterization Testing - ExtractionsTown Hall
09/09/2026Town Hall - Biocompatibility Risk AssessmentTown Hall
08/05/2026Public Meeting - Reauthorization of the Medical Device User Fee AmendmentsPublic Meeting
07/22/2026Town Hall - Content of Human Factors Information in Medical Device Marketing Submissions, Final GuidanceTown Hall
06/24/2026Webinar - Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation ChallengeWebinar
04/01/2026Town Hall - FDA’s Quality Management System Regulation (QMSR): Medical Device Risk-Based Inspections Town Hall
03/11/2026Town Hall - Clinical Decision Support Software, Final GuidanceTown Hall
02/18/2026Town Hall - Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, Final GuidanceTown Hall
02/11/2026Town Hall - General Wellness: Policy for Low Risk Devices, Final GuidanceTown Hall
01/14/2026Town Hall - Quality Management System Regulation: Risk and Design and DevelopmentTown Hall
12/16/2025Webinar - Quality Management System Regulation: Key TakeawaysWebinar
12/10/2025Webinar - Case Study: Material Substitutions in Devices Subject to Premarket Notification [510(k)] Using Polytetrafluoroethylene (PTFE)Webinar
01/14/2025Webinar - Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software FunctionsWebinar

DateEventEvent Type
12/04/2024Medical Device Sterilization Town Hall: Sterilization Short Topics, Series Impact, Wrap Up, and Next StepsTown Hall
12/03/2024Registration & Listing Requirements for In Vitro Diagnostic Products (IVDs), Including Laboratory Developed Tests (LDTs)Webinar
11/20/2024Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&ATown Hall
10/30/2024Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&ATown Hall
10/24/2024FDA’s Total Product Life Cycle Approach to In Vitro Diagnostic Products (IVDs)Webinar
10/15/2024Webinar - Draft Guidance: Incorporating Voluntary Patient Preference Information over the Total Product Life CycleWebinar
10/09/2024Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&ATown Hall
10/08/2024Webinar - The Voluntary Improvement Program: How to Enroll, Opportunities, and Best PracticesWebinar
09/11/2024Medical Device Sterilization Town Hall: Sterility Master Files and Effective Use in Premarket SubmissionsTown Hall
09/24/2024Webinar - Labeling Requirements for In Vitro Diagnostic Products (IVD), Including LDTs, Under 21 CFR 809.10(b)Webinar
09/10/2024Webinar - Final Guidance: Remanufacturing of Medical DevicesWebinar
09/03/2024Webinar - Draft Guidance: Predetermined Change Control Plans for Medical DevicesWebinar
11/06/2024Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical DevicesWorkshop
08/21/2024UGA/FDA 11th Annual Medical Device Regulations ConferenceConference
08/22/2024Webinar - In Vitro Diagnostic Products (IVDs) - MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint RequirementsWebinar
09/19/2024Public Workshop - Food and Drug Administration/National Institutes of Health Joint Workshop: Developing Implanted Brain-Computer Interface Clinical Outcome Assessments to Demonstrate BenefitWorkshop
07/16/2024Webinar - In Vitro Diagnostic Product (IVD): ClassificationWebinar
07/10/2024Medical Device Sterilization Town Hall: Mock Pre-Submission on Implementing a Change in Sterilization MethodTown Hall
05/23/2024Medical Device Sterilization Town Hall: Sterilization Method Selection for New and Existing DevicesTown Hall
06/05/2024Webinar - Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft GuidancesWebinar
05/29/2024Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product DevelopmentConference
05/14/2024Webinar - Final Rule: Medical Devices; Laboratory Developed TestsWebinar
04/29/2024Medical Device Sterilization Town Hall: Topics and Formats for the Continuing Sterilization SeriesTown Hall
04/16/2024Co-sponsored Public Meeting - Food and Drug Administration/Medical Device Innovation Consortium Symposium on Computational Modeling and SimulationMeeting
04/30/2024Webinar - Draft Guidance: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C ActWebinar
04/17/2024Virtual Public Workshop - Accreditation Scheme for Conformity Assessment ExpansionWorkshop
04/02/2024Co-sponsored Public Conference - Food and Drug Administration/Advanced Medical Technology Association Medical Device Statistical IssuesConference
03/21/2024Medical Device Sterilization Town Hall: The Value and Use of Recognized Consensus Standards in Premarket SubmissionsTown Hall
02/29/2024Medical Device Sterilization Town Hall: FDA’s Modifications Guidances and the Use of Device Master Files in Reviews Town Hall
02/07/2024Medical Device Sterilization Town Hall: Premarket Submission Expectations and Additional Considerations for Sterility ReviewTown Hall
01/26/2024Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO)Town Hall
01/11/2024Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Final Guidance Webinar
01/10/2024Medical Device Sterilization Town Hall: Overview of Sterilization Landscape and Role of Ethylene OxideTown Hall
06/12/2024Medical Device Sterilization Town Hall: Sterilization Open Q&ATown Hall
08/07/2024Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&ATown Hall

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