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Webinar - Two Draft Guidance Documents Clarifying When to Submit a 510(k) for a Change to an Existing Device - August 25, 2016

Webinar - Draft Guidance on “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product" - August 18, 2016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 Rule: Use of Symbols in Labeling - July 25, 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Webinar - Draft Guidance on “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions” - July 11, 2016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
Presentation   Printable Slides   Transcript

Color Additives for Medical Devices - February 12, 2016
Presentation   Printable Slides   Transcript

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

CDRH Industry Basics Workshop - Unique Device Identification (UDI), January 27, 2016
   Full Presentation
   UDI Overview: Slides - Transcript
   GUDID Account: Slides - Transcript

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

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

Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) Draft Guidance – October 23, 2014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

Custom Device Exemption - October 14, 2014
Presentation   Transcript   Printable Slides

Medical Devices in the Home: Design Considerations and Guidance for Industry – September 9, 2014 
Presentation   Printable Slides   Transcript

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

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

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

GUDID - Device Identifier Record – July 23, 2014 
Presentation   Printable Slides   Transcript

GUDID - HL7 SPL Submission Option Overview – July 2014
Presentation   Printable Slides   Transcript

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

Clinical Laboratory Improvement Amendments (CLIA) – March 18, 2014
Presentation   Printable Slides   Transcript

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

GUDID - Account Set-up – January 30, 2014
Presentation   Printable Slides   Transcript

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

FDA Guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices – November 6, 2013
Presentation   Printable Slides   Transcript

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

 

Page Last Updated: 08/25/2016
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