UNeMed seminar to focus on FDA approval of technology

Dan Bracco

FDA approval of technology will be the topic of a UNeMed sponsored seminar at 1 p.m. today in the Durham Research Center Auditorium.

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.

A question and answer session will immediately follow the seminar and refreshments will be served.