NHLBI Catalyze Webinar: Gaining the Edge - Medical Device Products Development to Regulatory

Event description

Presenter: Diane Earp, MSHS, SBB(ASCP)

This presentation provides a general overview of the medical device landscape for a sound regulatory plan/strategy and explains how it can provide a competitive edge for product development. Additionally, the speaker provides a list of reference material and discusses the evolving framework for new devices and combination product clearance/approval by the US FDA.

Webinar presented on June 22, 2021 to an invited audience.

This video is provided for educational purposes only.

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Chapters

0:28
Meeting Objectives
1:22
FDA Definition of Medical Device
4:33
Classification of Medical Device
6:30
Q Submission Program
7:31
Pre-Submission Meeting
10:03
Study Risk Determination
10:58
General Information (FDA) Meetings
11:33
Medical Device Classifications and FDA Regulatory Pathways
12:43
IDE Information
15:52
Regulation Submission Type and Timelines
18:41
Regulatory Considerations - Gaining the Competitive Edge
22:56
Device Documentation
26:18
Changes for the Framework for New Devices and Combination Products
38:50
FDA Regulations Applicable to Medical Devices
39:36
Reference Material and Resources
41:20
Questions/Contact Info
This research was, in part, funded by the National Institutes of Health (NIH) Agreement OT2 HL157844-01. The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the NIH.