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Title: A Case-Study Based Course on "Device Evaluation and FDA Approval" PDF
Url: http://search.asee.org/search/fetch?url=file%3A%2F%2Flocalhost%2FE%3A...
Creator: Cardinal, Kristen
Publisher: American Society for Engineering Education
Description: Preclinical evaluation of new devices and therapies is an integral part of research and development in the medical device industry, and the regulatory process for FDA approval is a major driving force behind much that goes on in a company setting. A large number of graduating biomedical engineers enter this medical device industry or a related environment upon graduation from our institution. Although these engineers are equipped to address many of the technical challenges that will arise, there is currently limited formal training in or exposure to the regulatory process that is required to bring new devices to market. Knowledge of the typical progression through preclinical testing, as well as an understanding of clinical trial guidelines and the FDA regulatory process would allow students to work more effectively and productively in industry or other medically-related positions. Therefore, a course has been designed entitled Device Evaluation and FDA Approval as an upper division elective at our institution. The goal of this course is to expose students to the overall process of FDA approval, including aspects of both preclinical and clinical testing, in order to prepare them to succeed in a regulatory-based environment. This is a case-study based course, where cases range from small in-class examples that facilitate active student engagement in the material, to large cases that span multiple lessons and incorporate out of class assignments and projects. Cases are selected and presented such that students gain insights into the progression and complexities of real-life devices, while learning in vitro and in vivo preclinical evaluation techniques, clinical trial guidelines, FDA processes and requirements, and overall regulatory constraints.
LC Classification: Medicine -- Medicine (General) -- Biomedical engineering. Electronics. Instrumentation
Medicine -- Medicine (General) -- Biomedical engineering. Electronics. Instrumentation -- Biomedical engineering as a profession. Biomedical technicians
Medicine -- Therapeutics. Pharmacology -- Therapeutics. Pharmacology -- Drugs and their actions -- Research. Experimental pharmacology. Drug development -- Clinical trials
GEM Subject: Science -- Engineering
Vocational Education -- Trade and industrial
Date Issued: 2008
Resource Type: Instructional Materials
Reading Materials
Science Materials
Format: pdf
Audience: College/University Instructors
Higher Education
Secondary Education
Technical School First Cycle
Technical School Second Cycle
University First Cycle
University Second Cycle
Vocational Training
Language: English
Rights: American Society for Engineering Education
Access Rights: Free access
Date Of Record Release: 2009-10-27 03:00:02 (W3C-DTF)
Date Last Modified: 2012-06-04 08:58:25 (W3C-DTF)
Source Type: ATE Center
Source: National Center for Manufacturing Education
Full Record Views: 61
Resource URL Clicks: 11
Cumulative Rating: NOT YET RATED
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