2014 FDA Regulatory Process Tutorial
Jack A. Kent, MBA, MPH, RAC
Blue Crab Device Consulting
Navigating FDA for Novel Micro/Nano Technologies
This discussion will focus on introducing FDA basics for entrepreneurs, walking through FDA clearance or approval pathways, expectations with new technologies, and common pitfalls to avoid. The talk will touch on specific guidance related to micro/nanotechnologies in order to position products for success with FDA. Finally, from an entrepreneurship perspective, this discussion will help innovators address the “FDA questions” from investors: how long will it take and how much will it cost? The session is geared toward an audience with great ideas but limited knowledge of FDA processes, delivering a broad overview of FDA basics and an understanding of how regulatory planning is crucial to the overall viability of a new venture.
Bio
Mr. Kent is the Founder and Principal Consultant at Blue Crab Device Consulting. The focus of this proprietorship is to assist start-up companies navigate the complex regulatory environment surrounding medical devices. In addition to improving health care delivery on a broad scale, Mr. Kent hopes to foster economic growth in Maryland through the development of novel technologies. To this end, he studied innovation and entrepreneurship at Johns Hopkins University, earning two masters degrees (in business and public health).
Mr. Kent previously served as Managing Director, Innovative Healthcare Products, at Becker & Associates Consulting, a boutique regulatory consulting firm located in Washington, D.C. Mr. Kent’s activities include analysis of complex regulatory challenges and regulatory strategy for innovative products, preparation of regulatory submissions, assistance with preclinical and clinical programs, assistance with defining and planning for unique FDA approval pathways, preparation for FDA meetings and Advisory Panels, postmarket product stewardship, and due diligence for investments and acquisitions.
Prior to Becker, Mr. Kent conducted circadian rhythm research at the University of Maryland School of Medicine using extracellular multi-electrode array recordings of neuronal organotypic cultures. Mr. Kent holds a B.S.E. in Bioengineering from the University of Pennsylvania, where his interests included tissue engineering and materials science.
