BIOENG 1355 - MEDICAL PRODUCT REGULATION AND REIMBURSEMENT

Minimum Credits: 3
Maximum Credits: 3
This course has been created as an introduction to the medical product development requirements of teh Food and Drug Agency (FDA). Also included is an overview of medical product reimbursement of the Centers for Medicare and Medicaid Services (CMS). The educational objectives for this course include: 1. How the history of the FDA affects the Agency's perspective and regulatory activities; 2. An introduction to quality systems with a focus on FDA's Quality System Regulation (QSR); 3. An overview of the key elements of teh Design Controls subsection of the FDA QSR; 4. How the regulatory requirements in Europe contrast with those of the FDA; 5. How FDA regulatory requirements differ from reimbursement policies of the CMS A series of case studies will be used to reinforce key lecture topics and prepare you to utilize this knowledge in the future whether that be clinical medicine, research, or industry. A secondary goal of this course is to prepare you to implement some of these practices during Senior Design.
Academic Career: Undergraduate
Course Component: Lecture
Grade Component: Letter Grade
Course Requirements: PLAN: Bioengineering

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