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Dan Bracco |
Dan Bracco, an industry representative for the Food and Drug Administration’s Hematology and Pathology Devices Panel and board member of the medical device consortium MassMEDIC, will discuss FDA approval in a seminar titled “The FDA: Historical Perspective and Approval Process Roadmap.”
UNeMed is UNMC’s marketing and licensing arm.
In his talk, Bracco will describe — in detail — the process to obtain FDA approval for medical devices and diagnostics. Included in his presentation will be a discussion of the different types of data required for FDA approval, how to deal with FDA and how to determine the FDA classification of new inventions.
Bracco has helped to lead both startup and established companies with market leading commercial success due to their FDA strategies.
Bracco has been involved in the regulatory, clinical and quality aspects of the medical device industry for the past 27 years. He currently is vice president of regulatory affairs and quality assurance at Hologic, Inc., where he is responsible for worldwide regulatory and quality in the surgical products division.
Bracco also is an adjunct instructor at Worchester Polytechnic Institute in Worchester, Mass.
He holds a bachelor’s degree in marketing from Hofstra University and another in mechanical engineering from the University of Massachusetts. He currently is working on his thesis for a master’s degree in regulatory affairs from the University of San Diego.
A question and answer session will immediately follow the seminar and refreshments will be served.