Course offering number:1002-704
Course ID:
2338
The Coming Medical Device Revolution
In Conjunction with Medical Device Summit
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This online training is valuable to professionals in the Medical Device industry.
It will be especially worthwhile to personnel involved in medical device manufacturing, medical device design, executives, managers and
regulatory professionals.
Description
This 90-minute accredited online training will focus on the upcoming major changes in the criteria and focus of the Medical Device registration
and review process within the FDA.
Module 1: The Root of the Problem
• Why the major revision?
– What is driving the concerns in what was the “model”
FDA division?
• Internal dissent:
– What caused Medical Device FDA people to raise
problems?
• The grandfathering dilemma:
– Are devices on the market without adequate testing?
– Are untested devices being used as predicates to
approve new products?
Module 2: What's Coming?
• Changes in predicates:
– To what extent should predicates be accepted?
– What changes are needed to assure safety?
• Pre-1976 devices:
– Are early predicates appropriate controls?
• Clinical (PMA) testing:
– When is a 510(k) not sufficient?
– What should trigger a Premarket Approval clinical
student?
Module 3: What to expect?
• New regulations:
– What's coming, when
• New harmonization:
– How will these changes affect harmonization with
EMEA guidelines?
• New interpretations:
– How will the FDA review applications?
Question and Answer Session
About Medical Device Summit
Medical Device Summit publishes news, technology, trends, regulations, and opinions, as well as offers educational, career advancement and networking opportunities to the global medical device and diagnostics industry. This information exchange is facilitated through ePublishing, digital and live events. By providing such an exchange of knowledge and technologies, MedicalDeviceSummit hopes to help advance the progress of the global medical device and diagnostic industry, thus, contributing to a healthier world.
MedicalDeviceSummit.com is an online meeting place and industry specific web site for the global medical device industry. The content is a mix of journalistic-style articles, technical articles, blogs, white papers, press releases and news.
For more information visit their website at www.medicaldevicesummit.com or email rbiros@InnovativePublishing.net.