Pitt | Swanson Engineering
Fernando Aguel Seminar
Fernando Aguel Seminar
March 26, 2015 | 04:00 PM - 05:00 PM | 157 Benedum Hall

An Introduction to FDA and Medical Device Regulation

Date: 3/26/2015 Time: 4:00 PM Location: 157 Benedum Hall
Fernando Aguel, MS
Branch Chief of Circulatory Support Devices Branch in Division of Cardiovascular Devices (DCD), United States Food and Drug Administration
Since 1976, the Center for Devices and Radiological Health (CDRH) has been charged with the regulation of medical devices. This presentation will go over what is considered a medical device, and how different medical devices (Class I, Class II and Class III devices) are regulated (Premarket noti-fication (510(k)), Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE)) and will provide an inside look into the review process of these devices. The presentation will also talk about different initiatives and programs at CDRH intended to promote medical device innovation and benefit the public health.

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