First Steps in the Regulatory Process

Tools

510(k) and Market Potential
Date: 7/28/2011
Length: 0 minutes
Speaker(s): Su-Mien Chong
Sources: Stanford Biodesign
Description: Paul Yock interviews Su-Mien Chong, regulatory consultant, on First Steps in the Regulatory process:
Question 6: Is it realistic to think with a single submission and a 510(k) clearance you have everything you need to go to market?

Other Videos in Series

510(k) and Market Potential
Su-Mien Chong
7/28/2011
Summary: Paul Yock interviews Su-Mien Chong, regulatory consultant, on First Steps in the Regulatory process:
Question 6: Is it realistic to think with a single submission and a 510(k) clearance you have everything you need to go to market?
Watch More
Choosing a Predicate
Su-Mien Chong
7/28/2011
Summary: Paul Yock interviews Su-Mien Chong, regulatory consultant, on First Steps in the Regulatory process: Question 5: Can you help us understand the predicate process and substantial equivalence?
Watch More
Classification of a Device
Su-Mien Chong
7/28/2011
Summary: Paul Yock interviews Su-Mien Chong, regulatory consultant, on First Steps in the Regulatory Process: Question 2: Can you tell us about how to classify a device? Watch More
How to Approach the Assignment of a Panel
Su-Mien Chong
7/28/2011
Summary: Paul Yock interviews Su-Mien Chong, regulatory consultant, on First Steps in the Regulatory process:
Question 9: How to approach the assignment of a panel? Watch More
Investigational Device Exemption
Su-Mien Chong
7/28/2011
Summary: Paul Yock interviews Su-Mien Chong, regulatory consultant, on First Steps in the Regulatory process:
Question 7: What is an investigational device exemption?
Watch More
Navigating the Pathway Design
Su-Mien Chong
7/28/2011
Summary: Paul Yock interviews Su-Mien Chong, regulatory consultant, on First Steps in the Regulatory Process:
Question 3: Can you give us some practical advice on navigating the pathways through the FDA?
Watch More
Pointers for Submissions
Su-Mien Chong
7/28/2011
Summary: Paul Yock interviews Su-Mien Chong, regulatory consultant, on First Steps in the Regulatory process:
Question 8: When it comes to processing a submission to the FDA do you have any pointers?
Watch More
Using the De Novo Pathway
Su-Mien Chong
7/28/2011
Summary: Paul Yock interviews Su-Mien Chong, regulatory consultant, on First Steps in the Regulatory process:
Question 4: When would an innovator use the de novo pathway?
Watch More
What Should Innovators Think About?
Su-Mien Chong
7/28/2011
Summary: Paul Yock interviews Su-Mien Chong, regulatory consultant, on First Steps in the Regulatory Process:
Question 1: Are there things in the early stages that a company or innovator should be thinking about?
Watch More

comments powered by Disqus

Search e360TV

Stay Connected

Email Newsletter Signup

Want to get connected? Sign up to receive regular news, polls and updates from The Kauffman Foundation.

Email Newsletters

Want to be up-to-date with the latest news and updates from Entrepreneurship.org? To subscribe, just give us your email address below; you'll choose which e-newsletters you'd like to receive on the next screen.