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Viewing: BME 6481 : Regulatory Law for Medical Devices

Last approved: Fri, 22 Apr 2016 09:15:20 GMT

Last edit: Fri, 18 Mar 2016 01:01:10 GMT

Catalog Pages referencing this course
School of Engineering and Applied Sciences
Biomedical Engineering (BME)
BME
6481
Regulatory Law for Medical Devices
Regulatory Devices
Fall 2016
3
Course Type
Lecture
Default Grading Method
Letter Grade

No
No

Corequisites

25
Jason Zara
Frequency of Offering
Every Year
Term(s) Offered
Fall
Are there Course Equivalents?
No
 
No
Fee Type


No


An introduction to legal issues pertinent to medical device regulation; device classification, general and special controls, quality system regulation, 510(k) submissions, premarket approval applications (PMAs), clinical trials, investigational device exemptions (IDEs) and medical device reporting (MDR), recalls, labeling and advertising, enforcement, and emerging legal issues. Pharmaceutical regulation.
Upon completing of this course, the student should be able to: 1. Understand the definitions of medical devices according to federal law 2. Understand how the FDA regulates medical devices and the mechanisms to obtain regulatory approval. 3. Understand issues of advertising and marketing as they pertain to federal law. 4. Understand what actions the government can take when laws and regulations are not followed.
There is no course at GW that specifically addresses the issue of regulatory law as it applies to medical devices.
Course Attribute


Key: 10379