Medical Devices

Medical Device Webinars and Stakeholder Calls

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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.

There are no webinars or stakeholder calls planned at this time, but please check back for updates.

Distinguishing Medical Device Recalls from Medical Device Enhancements – November 5, 2014
Recorded Webinar   Printable Slides   Transcript

CDRH Industry Basics Workshop (All Day Webinar) – November 4, 2014

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices – October 29, 2014
Recorded Webinar   Printable Slides   Transcript

Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) Draft Guidance – October 23, 2014
Recorded Webinar   Printable Slides   Transcript

Custom Device Exemption - October 14, 2014
Recorded Webinar   Transcript   Printable Slides

Medical Devices in the Home: Design Considerations and Guidance for Industry – September 9, 2014 
Recorded Webinar)   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: 11/14/2014
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