BME 3010 - Medical Device Regulation and Standards

• Describe the legislative and regulatory history of the FDA and the role of domestic and international regulatory bodies in the design, development, and marketing of medical devices.
• Demonstrate an understanding of medical device classification systems and the relationship between device class, associated risk, and applicable regulatory controls.
• Demonstrate an understanding of the premarket regulatory pathways for medical devices, including 510(k), De Novo, PMA, and HDE, and the conditions under which each applies.
• Demonstrate an understanding of the Quality Management System Regulation (QMSR) and its requirements across the total medical device lifecycle, from design and development through manufacturing, service, and postmarket activities.
• Describe the postmarket surveillance requirements for medical devices, including adverse event reporting, recalls, and postmarket studies.
• Demonstrate an understanding of the regulatory requirements for clinical studies involving medical devices, including the purpose and scope of the Investigational Device Exemption (IDE) process.
• Describe how the U.S. healthcare reimbursement system influences medical device development and market access decisions.
• Demonstrate an understanding of the risk management process and its role in medical device development and regulation.
• Demonstrate familiarity with consensus standards bodies and the standards they produce (ISO, IEC, AAMI/ANSI, UL, NFPA), and describe the role of standards in supporting medical device safety, effectiveness, and regulatory compliance.
• Demonstrate an ability to design basic experiments to assess medical device performance and substantial equivalency, and analyze the resulting data using appropriate statistical methods and professional software.
• Describe the regulatory requirements and guidance frameworks governing cybersecurity of medical devices across the total product lifecycle.
• Describe the regulatory requirements and responsible practices governing AI-enabled medical devices across the total product lifecycle.
• Describe the ethical considerations and societal implications of AI-enabled medical devices on patients and clinical decision-making.

• Hypothesis testing
• Basic design of experiments
• Probability density and distribution functions

• Introduction to the FDA and History of Medical Device Regulation
• Medical Device Definition and Classification
• Quality Management System Regulation and Good Manufacturing Practices
• Premarket Regulatory Pathways
• Postmarket Surveillance and Reporting
• Regulatory Requirements for Clinical Studies of Medical Devices
• Medical Device Standards and Their Role in Regulation
• Risk Management in Medical Device Development and Regulation
• Healthcare Economics and Reimbursement
• Cybersecurity of Medical Devices
• Global Regulatory Frameworks and International Device Regulation
• AI-Enabled Medical Devices and Social Responsibility