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.

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

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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Page Last Updated: 12/18/2018
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