Medical Devices

Medical Device Webinars and Stakeholder Calls

This page provides information on upcoming and past webinars held by the Center for Devices and Radiological Health (CDRH). Please see CDRH Learn for additional training modules.

Custom Device Exemption – October 14, 2014
Printable Slides

Medical Devices in the Home: Design Considerations and Guidance for Industry – September 9, 2014 
Recorded Webinar (9/9/14)   Printable Slides   Transcript

FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations – September 4, 2014
Recorded Webinar   Printable Slides   Transcript

Evaluation of Sex-Specific Data in Medical Device Clinical Studies – August 26, 2014
Recorded Webinar   Printable Slides   Transcript

The 510(k) Program Guidance: Evaluating Substantial Equivalence in Premarket Notifications – August 15, 2014
Video Closed Captioned   Printable Slides   Transcript

GUDID - Device Identifier Record – July 23, 2014 
Recorded Webinar   Transcript

Medical Device Classification and Reclassification Procedures – Proposed Rule – March 24, 2014
Recorded Webinar Closed Captioned   Printable Slides   Transcript

Clinical Laboratory Improvement Amendments (CLIA) – March 18, 2014
Audio Recording (MP3)   Printable Slides   Transcript

Pre-Submissions and Meetings with FDA Staff – February 28, 2014
Recorded Webinar Closed Captioned   Printable Slides   Transcript

GUDID - Account Set-up – January 30, 2014
Audio Recording (MP3)   Printable Slides   Transcript

Global Unique Device Identification Database (GUDID) – An Overview – December 18, 2013
Audio Recording (MP3)   Printable Slides   Transcript

FDA Guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices – November 6, 2013
Audio Recording (MP3)   Printable Slides   Transcript

IDEs for Early Feasibility Medical Device Clinical Studies, Including First in Human (FIH) Studies – October 23, 2013
Audio Recording (MP3)   Printable Slides   Transcript

 

Page Last Updated: 10/20/2014
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