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.

Date	Event Type	Event
01/14/2025	Webinar	Webinar – Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
12/04/2024	Town Hall	Medical Device Sterilization Town Hall: Sterilization Short Topics, Series Impact, Wrap Up, and Next Steps
12/03/2024	Webinar	Registration & Listing Requirements for In Vitro Diagnostic Products (IVDs), Including Laboratory Developed Tests (LDTs)
11/20/2024	Town Hall	Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A
10/30/2024	Town Hall	Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A
10/24/2024	Webinar	FDA’s Total Product Life Cycle Approach to In Vitro Diagnostic Products (IVDs)
10/15/2024	Webinar	Webinar - Draft Guidance: Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle
10/09/2024	Town Hall	Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A
10/08/2024	Webinar	Webinar - The Voluntary Improvement Program: How to Enroll, Opportunities, and Best Practices
09/11/2024	Town Hall	Medical Device Sterilization Town Hall: Sterility Master Files and Effective Use in Premarket Submissions
09/24/2024	Webinar	Webinar - Labeling Requirements for In Vitro Diagnostic Products (IVD), Including LDTs, Under 21 CFR 809.10(b)
09/10/2024	Webinar	Webinar - Final Guidance: Remanufacturing of Medical Devices
09/03/2024	Webinar	Webinar - Draft Guidance: Predetermined Change Control Plans for Medical Devices
11/06/2024	Workshop	Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices
08/21/2024	Conference	UGA/FDA 11th Annual Medical Device Regulations Conference
08/22/2024	Webinar	Webinar - In Vitro Diagnostic Products (IVDs) - MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements
09/19/2024	Workshop	Public Workshop - Food and Drug Administration/National Institutes of Health Joint Workshop: Developing Implanted Brain-Computer Interface Clinical Outcome Assessments to Demonstrate Benefit
07/25/2024	Meeting	Virtual Public Meeting - Home as a Health Care Hub - Stakeholder Listening Session
07/16/2024	Webinar	Webinar - In Vitro Diagnostic Product (IVD): Classification
07/10/2024	Town Hall	Medical Device Sterilization Town Hall: Mock Pre-Submission on Implementing a Change in Sterilization Method
06/26/2024	Workshop	Co-sponsored Public Workshop - Using Patient Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Lifecycle
05/23/2024	Town Hall	Medical Device Sterilization Town Hall: Sterilization Method Selection for New and Existing Devices
06/05/2024	Webinar	Webinar - Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances
05/29/2024	Conference	Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development
05/14/2024	Webinar	Webinar - Final Rule: Medical Devices; Laboratory Developed Tests
04/29/2024	Town Hall	Medical Device Sterilization Town Hall: Topics and Formats for the Continuing Sterilization Series
04/16/2024	Meeting	Co-sponsored Public Meeting - Food and Drug Administration/Medical Device Innovation Consortium Symposium on Computational Modeling and Simulation
04/30/2024	Webinar	Webinar - Draft Guidance: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act
04/17/2024	Workshop	Virtual Public Workshop - Accreditation Scheme for Conformity Assessment Expansion
04/02/2024	Conference	Co-sponsored Public Conference - Food and Drug Administration/Advanced Medical Technology Association Medical Device Statistical Issues
03/21/2024	Town Hall	Medical Device Sterilization Town Hall: The Value and Use of Recognized Consensus Standards in Premarket Submissions
02/29/2024	Town Hall	Medical Device Sterilization Town Hall: FDA’s Modifications Guidances and the Use of Device Master Files in Reviews
02/07/2024	Town Hall	Medical Device Sterilization Town Hall: Premarket Submission Expectations and Additional Considerations for Sterility Review
01/26/2024	Town Hall	Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO)
01/11/2024	Webinar	Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Final Guidance
01/10/2024	Town Hall	Medical Device Sterilization Town Hall: Overview of Sterilization Landscape and Role of Ethylene Oxide
06/12/2024	Town Hall	Medical Device Sterilization Town Hall: Sterilization Open Q&A
08/07/2024	Town Hall	Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A

Events Held in Prior Years

Date	Event Type	Event
12/12/2023	Webinar	Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program
12/05/2023	Webinar	Immediately-in-effect guidance: Antimicrobial Susceptibility Test System Devices - Updating Breakpoints in Device Labeling
11/28/2023	Conference	UGA/FDA 10th Annual Medical Device Regulations Conference
11/14/2023	Webinar	Breakthrough Devices Program Updated Final Guidance
11/02/2023	Webinar	Final Guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
11/02/2023	Virtual Public Workshop	Extended Reality in Orthopedic Surgical Devices: Insights into User Experience and Adverse Event Reporting for Patient Safety
10/31/2023	Webinar	Proposed Rule: Medical Devices; Laboratory Developed Tests
10/26/2023	Webinar	CDRH's New Draft Guidances to Continue to Modernize the 510(k) Program
10/12/2023	Webinar	Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Final Guidance
09/29/2023	Virtual Public Workshop	Patient-Reported Outcomes and Vision Related Quality of Life Questionnaires
09/14/2023	Webinar	Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder - Draft Guidance
09/12/2023	Webinar	Qualification of Medical Device Development Tools
07/20/2023	Webinar	Final Guidance: Content of Premarket Submissions for Device Software Functions
04/26/2023	Virtual Town Hall	Test Development and Validation During the COVID-19 Public Health Emergency
04/18/2023	Webinar	Webinar on Guidances on COVID-19 Transition Plans for Medical Devices
04/13/2023	Webinar	Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions Draft Guidance
04/26/2023	Virtual Town Hall	Test Development and Validation During Public Health Emergencies Monkey pox (mpox) and COVID-19
02/02/2023	Webinar	Electromagnetic Compatibility (EMC) of In Vitro Diagnostic Devices

 

• 2019-2022 Webinars
• 2022 Workshops (Archived)
• 2021 Workshops (Archived)
• 2020 Workshops (Archived)
• 2019 Workshops (Archived)
• 2018 Workshops (Archived)
• 2017 Workshops (Archived)
• 2016 Workshops (Archived)