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In this section: Workshops & Conferences (Medical Devices)

CDRH Webinars

The CDRH Webinar Program educates stakeholders on guidances, regulations, and various policies for medical devices and radiation-emitting electronic products. The format generally consists of a presentation on a specific topic by an FDA official, followed by an interactive question and answer session with stakeholders. The intended audience for CDRH webinars is regulated industry.

This page provides information on upcoming and past events. Additional industry education is provided on CDRH Learn and Device Advice.

Upcoming Webinars

Webinar - Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Final Guidance - January 11, 2024

Past Webinars 2023

Webinar - Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program - December 12, 2023

Webinar - Immediately-in-effect guidance: Antimicrobial Susceptibility Test System Devices - Updating Breakpoints in Device Labeling - December 5, 2023

Webinar - Breakthrough Devices Program Updated Final Guidance - November 14, 2023

Webinar - Final Guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - November 2, 2023

Webinar - Proposed Rule: Medical Devices; Laboratory Developed Tests - October 31, 2023

Webinar - CDRH's New Draft Guidances to Continue to Modernize the 510(k) Program - October 26, 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 - October 12, 2023

Webinar - Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder - Draft Guidance - September 14, 2023

Webinar - Qualification of Medical Device Development Tools - September 12, 2023

Webinar - Final Guidance: Content of Premarket Submissions for Device Software Functions - July 20, 2023

Virtual Town Hall Series - Test Development and Validation During the COVID-19 Public Health Emergency - April 26, 2023

Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023

Webinar - Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions Draft Guidance - April 13, 2023

Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies Monkey pox (mpox) and COVID-19 - March 22, 2023

Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies Monkey pox (mpox) and COVID-19 - February 15, 2023

Webinar – Electromagnetic Compatibility (EMC) of In Vitro Diagnostic Devices - February 2, 2023

Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies Monkey pox (mpox) and COVID-19 - January 11, 2023

Past Webinars 2022

Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies Monkey pox (mpox) and COVID-19 - December 14, 2022

Webinar – Final Guidances on Post-Approval Study Requirements and Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act - December 6,2022

Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies (Monkeypox and COVID-19) - November 30, 2022

Webinar - Computer Software Assurance for Production and Quality System Software Draft Guidance - October 27, 2022

Virtual Town Hall Series - Monkeypox and COVID-19 Test Development and Validation - Multiple Dates

Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies (Monkeypox and COVID-19) - October 26, 2022

Webinar - Clinical Decision Support Software Final Guidance - October 18, 2022

Webinar - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Draft Guidance - June 14, 2022

Webinar - Patient Engagement in the Design and Conduct of Medical Device Clinical Studies - Final Guidance - March 22, 2022

Webinar - Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation - Final Guidance - March 1, 2022

Webinar on Draft Guidances on Transition Plans for COVID-19 Related Medical Devices - February 22, 2022

Past Webinars 2021

Webinar - Draft Guidance: Content of Premarket Submissions for Device Software Functions - December 16, 2021

Webinar - De Novo Classification Process and FDA and Industry Actions: Effect on FDA Review Clock and Goals, Final Guidances - December 14, 2021

Webinar on Proposed Rule for Establishing Over-the-Counter Hearing Aids and Draft Guidance for Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - December 7, 2021

Webinar on Implanted BCI Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations Final Guidance - July 29, 2021

Webinar - Remanufacturing of Medical Devices Draft Guidance and Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices Discussion Paper - July 27, 2021

Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - July 13, 2021

Webinar - Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment - June 24, 2021

Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - June 8, 2021

Webinar - ASCA Pilot: Streamlining Conformity Assessment in Device Submissions - May 20, 2021

Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - April 27, 2021

Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - February 23, 2021

Webinar - Safer Technologies Program: Final Guidance - February 1, 2021

Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - January 26, 2021

For a full listing of 2020-2019 webinars visit the FDA.gov Archive

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