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In this section: Workshops & Conferences (Medical Devices)

Medical Device Webinars and Stakeholder Calls

The FDA's Center for Devices and Radiological Health (CDRH) hosts webinars and calls to educate stakeholders on guidances and other topics related to the regulation of medical devices and radiation-emitting products. These forums provide the medical device industry and others with the chance to interact with FDA officials and have their questions answered.

This page provides information on upcoming and past webinars and calls held by CDRH. Additional industry education is provided on CDRH Learn.

Upcoming Webinars and Stakeholder Calls

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

Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 12, January 26, February 9, and February 23

Past Webinars and Stakeholder Calls - 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Webinar - Draft Guidance: Content of Premarket Submissions for Device Software Functions - December 16, 2021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Webinar on Proposed Rule for Establishing Over-the-Counter Hearing Aids and Draft Guidance for Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - December 7, 2021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Webinar - Remanufacturing of Medical Devices Draft Guidance and Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices Discussion Paper - July 27, 2021
TAKE OUR SURVEY - Tell us what you think about the webinar

Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - July 13, 2021
TAKE OUR SURVEY - Tell us what you think about the webinar

Webinar - Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment - June 24, 2021
TAKE OUR SURVEY - Tell us what you think about the webinar

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
TAKE OUR SURVEY - Tell us what you think about the webinar

Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - April 27, 2021
TAKE OUR SURVEY - Tell us what you think about the webinar

Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - February 23, 2021
TAKE OUR SURVEY - Tell us what you think about the webinar

Webinar - Safer Technologies Program: Final Guidance - February 1, 2021
TAKE OUR SURVEY - Tell us what you think about the webinar

Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - January 26, 2021
TAKE OUR SURVEY - Tell us what you think about the webinar

Past Webinars and Stakeholder Calls - 2020

Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - December 16, 2020
TAKE OUR SURVEY - Tell us what you think about the webinar

Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - December 8, 2020
TAKE OUR SURVEY - Tell us what you think about the webinar

Webinar - Digital Health Center of Excellence Listening Session #2 - November 12, 2020

Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - October 27, 2020

Webinar - Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidances - October 22, 2020

Webinar - Digital Health Center of Excellence Listening Session #1 - October 19, 2020

Webinar - Recognition and Withdrawal of Voluntary Consensus Standards - Final Guidance - October 15, 2020

Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - October 13, 2020

Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - September 29, 2020

Webinar - Safety and Performance Based Pathway Criteria for Certain Device Types Final Guidances - September 24, 2020

Webinar Series - Gowns and Other Apparel for Use by Health Care Personnel in COVID-19 Pandemic - September 15, 2020

Webinar - Multiple Function Device Products: Policy and Considerations - September 10, 2020

Webinar Series - CDC/NIOSH's Surgical N95 Respirator Guidance - September 1, 2020

Webinar - Regulatory Overview for Developers and Sponsors of Neurological and Physical Medicine Devices: An Introduction to the De Novo Pathway - August 27, 2020

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - August 26, 2020

Webinar Series - FDA’s Surgical Masks Umbrella EUA - August 26, 2020

Webinar Series - FDA’s Regulation of Face Masks and Surgical Masks During the COVID-19 Pandemic - August 4, 2020

Webinar Series - Respirators for Health Care Personnel Use during COVID-19 Pandemic - July 21, 2020

Webinar Series - Respirators for Health Care Personnel Use during COVID-19 Pandemic - July 7, 2020

Webinar Series - Respirators for Health Care Personnel Use during COVID-19 Pandemic - June 23, 2020

Webinar Series - Respirators for Health Care Personnel Use during COVID-19 Pandemic - June 9, 2020

Virtual Town Hall - 3D Printed Swabs - May 15, 2020

Webinar - Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency - May 11, 2020

Webinar - 510(k) Third Party Review Program: Final Guidance - April 16, 2020

Webinar - Clinical Laboratory Improvement Amendments (CLIA) Waiver Applications Final Guidances - April 14, 2020

Webinar - Enforcement Policy for Personal Protective Equipment (PPE) During COVID-19: Immediately in Effect Guidance - April 6, 2020

Past Webinars and Stakeholder Calls - 2019

Webinar - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Final Guidance - November 14, 2019

Webinar - Safety and Performance Based Pathway Performance Criteria - November 7, 2019

Webinar - Safer Technologies Program: Draft Guidance - November 6, 2019

Webinar - Clinical Decision Support Software: Draft Guidance - November 4, 2019

Webinar - The Special 510(k) Program: Final Guidance - October 31, 2019

Webinar - Collaborative Communities - October 29, 2019

Webinar - Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Draft Guidance - October 28, 2019

Webinar - Humanitarian Device Exemption Program - October 21, 2019

Webinar - Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions: Final Guidance - October 16, 2019

Webinar - Dental Devices Premarket Submissions - October 2, 2019

Webinar - Acceptance Review for De Novo Classification Requests: Final Guidance - September 18, 2019

Webinar - Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Final Guidance - August 22, 2019

Webinar - FDA Innovation Challenges: Identify Sterilization Alternatives and Reduce Ethylene Oxide Emissions - August 13, 2019

Webinar - Q-Submission Program for Medical Device Submissions - June 11, 2019

Webinar - Unique Device Identification: Convenience Kits Final Guidance - May 21, 2019

Webinar - Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Final Guidance - April 23, 2019

Webinar - Implementation of Final Rule on Human Subject Protection: Acceptance of Data from Clinical Investigations for Medical Devices - March 19, 2019

Webinar - The Least Burdensome Provisions: Concept and Principles Final Guidance - March 14, 2019

Webinar - Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices - February 12, 2019

User Session - Digital Health Software Precertification (Pre-Cert) Pilot Program - February 7, 2019

Webinar - Breakthrough Devices Program Final Guidance - January 17, 2019

Webinar - CLIA Waiver Applications Draft Guidances - January 9, 2019

Past Webinars and Stakeholder Calls - 2018

Webinar - Special 510(k) Program Pilot - November 8, 2018

Webinar - Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Final Guidance - November 1, 2018

Webinar - Appropriate Use of Voluntary Consensus Standards; Final Guidance - October 25, 2018

Webinar - Quality in 510(k) Review Program Pilot - October 10, 2018

Webinar - FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder - July 25, 2018

Webinar - Final Guidances on Next Generation Sequencing-based Tests - May 24, 2018

User Session - Digital Health Software Precertification (Pre-Cert) Pilot Program - May 10, 2018

Webinar - Duodenoscope Sampling and Culturing - March 22, 2018

Webinar - Combination Product Updates for "Acceptance and Filing Reviews for Premarket Approval Applications" and "Refuse to Accept Policy for 510(k)s"- March 20, 2018

Webinar - Custom Device Annual Reporting - February 27, 2018

Webinar - FDA Categorization of Investigational Device Exemption Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions - January 16, 2018

Webinar - Technical Considerations for Additive Manufactured Medical Devices - January 10, 2018

Webinar - Pediatric Information for X-ray Imaging Device Premarket Notifications: Final Guidance - January 9, 2018

Past Webinars and Stakeholder Calls - 2017

Webinar - Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to Humanitarian Device Exemptions (HDEs) - December 18, 2017

Webinar - Unique Device Identification: Direct Marking of Devices Final Guidance – Thursday, November 30, 2017

Webinar - De Novo Classification Process (Evaluation of Automatic Class III Designation) - November 21, 2017

Webinar - PreCertification (Pre-Cert) Pilot Update - November 17, 2017

Webinar - Final Guidances on "Deciding When to Submit a 510(k) for a Change to an Existing Device" and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" - November 16, 2017

Webinar - Final Guidance on "Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies" - October 31, 2017

Webinar - Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices Final Guidance - October 26, 2017

Webinar - Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - October 10, 2017

Webinar - CDRH Final Guidance: Qualification of Medical Device Development Tools - August 24, 2017

Optimizing GUDID Data Quality- August 3, 2017

Webinar - Digital Health Software Precertification (PreCert) Pilot Program - August 1, 2017

Webinar - Regulatory Overview for Developers and Sponsors of Neurological Devices: Introduction to Premarket Approvals - July 26, 2017

Webinar - Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to the De Novo Pathway - March 22, 2017

Webinar - Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions Final Guidance - February 23, 2017

Webinar - Final Guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions - February 9, 2017

Webinar - Final Guidance on Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types - February 2, 2017

Webinar - Postmarket Management of Cybersecurity in Medical Devices Final Guidance - January 12, 2017

Past Webinars and Stakeholder Calls - 2016

Webinar - Final Guidance on Medical Device Reporting for Manufacturers - November 30, 2016

Webinar - Final Guidance Documents: "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" and "Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use" - November 21, 2016

Webinar - CDRH Industry Basics Workshop: The Quality System - November 3, 2016

Webinar - Final Guidance on Patient Preference Information - September 27, 2016

Webinar - Final Guidance on Adaptive Designs for Medical Device Clinical Studies - September 22, 2016

Webinar - Regulatory Advice for Investigators and Sponsors of Neurological Devices and the Path to Initiating Human Studies - September 14, 2016

Webinar - Final Guidance on "General Wellness: Policy for Low-Risk Devices" - September 1, 2016

Webinar - Draft Guidance on "Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product" - August 18, 2016

Webinar - Final Guidance on "Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices" - August 8, 2016

Webinar - Next Generation Sequencing (NGS) Draft Guidances: Technical and Regulatory Aspects - July 27, 2016

Webinar - Next Generation Sequencing (NGS) Draft Guidances: Implications for Patients and Providers - July 27, 2016

Webinar - Final Guidance on "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - July 21, 2016

Webinar - An Update on the FDA's Medical Device Clinical Trials Program - July 14, 2016

Webinar - Draft Guidance on "Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions" - July 11, 2016

Announcing Final Guidance on Postmarket Surveillance Under Section 522 of the Food, Drug, and Cosmetic Act and FDA Webinar on the Final Guidance - June 28, 2016

Artificial Pancreas: A Dialogue between the FDA and the Diabetes Community - June 2, 2016

CDRH Industry Basics Workshop - Unique Device Identification (UDI) Part II, Submitting Information to GUDID - March 10th, 2016

Applying Human Factors and Usability Engineering to Medical Devices - February 19, 2016

Color Additives for Medical Devices - February 12, 2016

Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Final Guidance - February 11, 2016

CDRH Industry Basics Workshop - Unique Device Identification (UDI) - January 27, 2016

Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings - January 21, 2016

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