Added Recorded Webinar and Transcript for the Distinguishing Medical Device Recalls from Medical Device Enhancements Webinar ? November 5, 2014

Distinguishing Medical Device Recalls from Medical Device Enhancements – November 5, 2014
Printable Slides   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Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) Draft Guidance – October 23, 2014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    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    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    Printable Slides   Transcript

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