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FDA Novel Device Programs: Breakthrough Device Designations and Safer Technologies Program
December 2 @ 3:00 am
Heads turn and crowds make way for VIPs as they make their way down the red carpet. What if your medical device could receive this same treatment? The FDA novel device programs (Breakthrough Device Designation program and STeP) are ways to roll out the red carpet for a device to achieve commercialization. This discussion will provide insights to help you understand the FDA Breakthrough Device Designation and Safer Technologies Program (STeP) and determine whether one of these designations should be considered as part of your device development program. DuVal & Associates will share experiences and best practices to help you successfully navigate the process for these novel device programs to accelerate commercialization of your product that is worthy of VIP status.
In this program, we will cover the following topics
Foundations and history of novel device programs
Breakthrough Device and Safer Technologies Criteria
How to complete your request
Kathy Herzog, BSME, is a Regulatory Consultant at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. She has worked in the medical device industry for 35 years, primarily in the areas of product design and development, regulatory, and project/program management activities for class III products in the urological, neuromodulation, drug delivery and pain control therapeutic areas.
Prior to joining DuVal & Associates, Kathy worked 26 years at Medtronic in various roles and responsibilities including regulatory strategy planning for US, EU, CAN, and AU submissions (i.e., IDEs, original PMA, PMA supplements, FDA advisory panel meetings, and design dossiers for CE Mark), labeling development, promotional copy review, off-label information management, risk assessment, adverse event reporting, call center management, business process improvement, quality system compliance, SOP development, compliance training, Medical Affairs, and multiple local and global project and program management activities.
Kathy earned a Bachelor of Science in Mechanical Engineering from the University of Wisconsin-Platteville. She has a Green Belt certificate in Lean Six Sigma.
Lisa Pritchard, BSEEE, is a Regulatory, Quality & Compliance Consultant at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. She focuses on advising clients on Regulatory, Quality and Compliance topics.
Lisa works extensively assisting clients with worldwide regulatory strategies, marketing submissions and applications (FDA submissions such as pre-submissions, IDEs, breakthrough Device Designations, 510(k)s, De Novos, PMAs, Emergency Use Authorizations, and advisory panel meeting preparation; European Design Dossiers, Technical Files, and Clinical Evaluation Plans and Reports; Canadian license applications; and Australian listing applications); quality system strategies, SOP development and review, and compliance topics. Lisa brings over 30 years of experience in working with industry.
Prior to joining DuVal & Associates, she executed successful Regulatory, Quality and Compliance strategies at a variety of device companies including American Medical Systems, Medtronic, Uromedica, and EnteroMedics. She brings extensive experience in strategy development, submission preparation, regulatory body negotiations, advertising/promotional materials assessment, inspection/audit preparation and conduct, quality system design, risk assessment, development of design control documentation, usability evaluations, clinical trial design, and adverse event reporting.
Lisa earned her Bachelor of Science, Electrical and Electronics Engineering, from North Dakota State University.