Congratulations – you have a new, cutting edge device. Your next steps for getting approval, clearance or clinical studies are key. Having an informal meeting with the FDA’s Pre-Sub program will help you achieve this. If you have never submitted a Pre-Sub, this webcast will teach you when it should be used, offer practical tips, highlight case studies and provide insight on how to develop an invaluable, long-term relationship with FDA personnel. You will also come away with more knowledge about general principles applicable to a variety of early regulatory agency interactions. Regulatory professionals with beginning to intermediate levels of experience are encouraged to attend.
Learning Levels: Basic & Intermediate
Upon the webcast's conclusion, you will:
- Understand the Pre-Sub program’s purpose and mechanics
- Understand basic Pre-Sub application contents
- Understand how to get the most out of a Pre-Sub interaction
- Learn principles and effective strategies for any informal FDA meeting
Who Should Attend?
- Regulatory personnel
- Development engineers
- Program or project managers
Dan Dillon, regulatory scientist, MED Institute
Dan Dillon has more than 30 years of experience in medical device testing, data analysis and global regulatory submission preparation. He has worked with a variety of companies, including Stryker, MDCI, Waters Corporation, Boston Scientific, American Sterilizer and Olympus. Dillon has worked on more than 90 510(k)s, as well as PMA, IDE and HUD/HDE submissions. With this experience has come a broad exposure to a wide variety of medical devices: vascular and non-vascular stents, capital equipment, endoscopes, catheters, emergency medical devices, drug/device combinations, apheresis devices and ophthalmological products, to name a few. Dillon has provided regulatory strategy, team leadership and FDA meeting coordination for numerous projects. He is Regulatory Affairs Certified (RAC), a member of Cook Group’s FDA Policy Working Group, and provides instruction on FDA submissions at Purdue University. Dillon holds an MS in applied statistics from Purdue.
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