Regulatory Affairs and Services (RAS) Courses for Graduate Students Only
RAS 621. Legal Basis for Medical Device Product Regulation
Upon completion of this course the students will be knowledgeable about the objective and structure of the FDA, key regulations associated medical devices, and the resources available from the FDA to aid in compliance with those regulations. 3 credits
RAS 623. Investigational Medical Device Regulations, Standards and Guidelines
Pertinent ethical, industrial, and federal standards and guidelines governing the implementation of medical experiments will be discussed. Specific topics to be addressed include investigational device exemptions, humanitarian use of medical devices, and emergency use of unapproved medical products. 3 credits
RAS 625. Regulatory Submission/Application Requirements for Medical Devices: Routes to Market
Reviews the laws and federal regulations that are applicable to medical devices in the United States .The medical device classification process will be discussed. Prereq.: RAS 621. 3 credits
RAS 627. International Regulatory Affairs: European Union (EU), Canada, Japan, and Australia
Reviews the authorization procedures that are applicable to medical devices that are scheduled to be marketed in the following international markets: European Union (EU), Canada, Japan, and Australia. The routes to market will be outlined. Prereq.: RAS 621. 3 credits
RAS 631. Clinical Study Design, Implementation, and Analysis
Presents the epidemiological and bio statistical principles underling clinical research of medical devices. The most common study designs used to evaluate medical devices are presented. Prior course in Introductory Statistics or Bio statistics is desirable. 3 credits
RAS 633. Quality Systems for Regulated Industries
Training in the content and scope of Quality Systems necessary to be an effective participant/leader in the regulated medical device industry including the evolution of quality system requirements and current perspectives on the interpretation of standards. 3 credits
RAS 635. Regulatory Affairs Compliance
Students will be knowledgeable about the regulations associated with device product listing, facility registration, product complaint management, aware of other considerations associated with compliance such as liability, root cause analyses, effective communication, and ethical considerations. Prereq.: RAS 633. 3 credits
RAS 641. Health Policy and the Medical Technology Industry
Historical perspective of the role of health policy in the development and diffusion of medical technology. Policy issues will be framed in the context of promoting versus inhibiting technology development and diffusion. A major portion of this class will be devoted to analysis and critique of current and proposed health policies as they affect the medical technology industry. 3 credits
RAS 643. Cost Management of Regulated Health Care Technology
Upon completion of the course, student will be able to describe the four basic types of economic evaluations and their intrinsic components, be able to describe the modifications required based upon the perspective of the evaluation and critically appraise a published economic analysis of a medical technology. Prereq.: RAS 641. 3 credits
RAS 645. Reimbursement for Medical Technology
Covers overview of requirements for reimbursement for medical devices. Students will understand the relationship between the three components of reimbursement: coverage, coding, and payment. Students will be able to state the basic components required to assess reimbursement for a new technology and be able to draft a preliminary strategy for gaining reimbursement. Prereq.: RAS 631. 3 credits
RAS 690. Regulatory Affairs Culminating Project
Culminating experience: research project, starred paper, and seminar. Student will develop, carry out and report [in written and oral format] on an individual research project related to the content of the program courses. Project requires approval of instructor. Students may take course over one to three semesters, for a total of 3 credits required for degree completion. 1-3 credits
