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
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04/30/2024	Webinar	Webinar - Draft Guidance: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act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

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
03/22/2023	Virtual Town Hall	Test Development and Validation During Public Health Emergencies Monkey pox (mpox) and COVID-19
02/15/2023	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
01/11/2023	Virtual Town Hall	Test Development and Validation During Public Health Emergencies Monkey pox (mpox) and COVID-19

Events Held in Prior Years

Subscribe to CDRHNew