Academic Center of Regulatory Affairs (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. Regulatory Routes to Market: 510(k)s.
U.S. route to market for medical devices, the Premarket Notification of 510(k), and regulation and requirements. Best practices associated with the preparation and clearance of Premarket Notifications. Developing regulatory strategies for markets. Prereq.: 621. 3 credits F, S, SUM.
RAS 625. Regulatory Routes to Market: PMAs.
U.S. route to market for high risk medical devices, Pre-market Approval Application (PMS) and Pre-Market Approval regulation and requirements. Best practices associated with the preparation and approval of PMS’s. Developing regulatory strategies for markets. Prereq.: 621. 3 credits F, DEMAND.
RAS 627. International Regulatory Affairs: European Union, Eastern Europe, Australia and Canada.
International regulatory affairs for medical devices with emphasis on the European Union (EU), Eastern Europe, Australia and Canada. Regulatory requirements. Classification, marketing submissions, and pre- and post-market approval requirements. Regulatory strategies for global market introduction and planning for the challenges of global regulation. 3 credits F, S, SUM.
RAS 631. IDE Regulations and Clinical Trial Design.
Conducting clinical research on unapproved medical devices. Pre and post market approval requirements under the FDA Investigational device Exemption (IDE) regulations and the logistics of conducting clinical trials. Principles of clinical trial design including clinical objectives, epidemiological, and statistical considerations. Common study designs and scientific and practical advantages and disadvantages. Clinical Trial Life Cycle (Planning, Initiation, Execution, and Closure) presented. Prereq.: 621. 4 credits F, S, SUM.
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. Reimbursement and Cost Management for Medical Technology.
Reimbursement and the role of health economics in the adoption of medical technology. Coverage, coding and payment, and their interdependencies. Economic evaluations for medical technology and the impact of economic evaluation on reimbursement decisions. 3 credits F, S, SUM.
RAS 651. Regulation of Combination Products.
Regulatory requirements for combination products that include medical devices and drugs or biologics. FDA procedures for determining how combination products are regulated and applicable pre- and post-market requirements. International requirements for combination products. Prereq.: 623, 625, 633. 3 credits F, S, SUM.
RAS 653. Regulatory and Clinical Ethics Involving Medical Devices.
Analyzing and responding to ethical issue affecting patients, physicians, government regulators and customers. Applicable codes of conduct, regulations and guidances. Case studies involving medical devices with regulatory and clinical ethical issues. Prereq.: 621, 631. 3 credits F, S, SUM.
RAS 655. International Regulatory Affairs: Japan, Other Asia, South America and Middle East.
International regulatory requirements for medical devices with emphasis on Japan, other Asia, South America, and the Middle East. Medical device regulations, regulatory requirements and trends including classification, marketing submissions and post-approval processes. Developing, planning, and organizing regulatory strategies for successful global market. 3 credits F, S, SUM.
RAS 657. Advanced Reimbursement and Cost management for Medical Technology.
Advances reimbursement and economic evaluations for medical technology. Development of clinical and reimbursements strategies to address the three components of reimbursement. Assessing clinical data and conducting economic evaluations for medical technology. Prereq.: 643. 3 credits F, S, SUM.
RAS 690. Regulatory Affairs Culminating Project.
A project based on knowledge from program courses. Background research and project scope. Written report and oral presentation. One to three semesters. 2 credits
