BME Seminar Series: Dr. Joan E. Adamo

Topics in Medical Technology Regulations: Classification of Medical Devices within the FDA Regulatory Framework

Associate Director, Regulatory Support Services, Adjunct Assistant Professor, Biomedical Engineering Clinical & Translational Science Institute, University of Rochester Medical Center

Abstract

The University of Rochester Biomedical Engineering Department and the CTSI announce a four-seminar series during the fall 2012 semester that will provide an overview of FDA medical device regulation, while addressing how the regulatory path can influence design and testing of medical technology. The first seminar will introduce medical devices, the concept of significant risk, and describe the multiple levels of device classifications. The second seminar will have two parts; the first exploring the creation of a design history file and the development of a device using the waterfall design process. The second part of this seminar will evaluate key regulatory steps involved in clinical testing of the device. Seminar three will consider the regulatory pathways to bring products to market. The final seminar will feature case studies that illustrate some challenging regulatory situations. Each seminar will build on previous discussions, but are designed to offer stand-alone content. Real examples throughout the series will provide context for the regulations, and comparisons with the regulation of drugs and biologics will illustrate key points.