BME 3010 - Medical Device Regulation and Standards

3 lecture hours 0 lab hours 3 credits

Course Description
This course addresses the regulatory requirements of medical device development and marketing in the United States and internationally. Specifically, the role of Food and Drug Administration (FDA) and international regulatory bodies in the design, development, evaluation, and marketing of medical devices is discussed. Specific regulatory pathways for premarket approval and postmarket surveillance are presented. The use of standards and risk management, and their role in the regulation of medical devices is stressed. The course also addresses the unique patient safety and effectiveness concerns associated with medical devices, specifically with regard to preclinical and clinical testing and evaluation. To this end, classic experimental design of clinical trials, statistical analysis techniques, and hypothesis testing for device evaluation are presented. The use and interpretation of statistical software are also covered in this course.
Prereq: MTH 2480, junior standing (quarter system prereq: none)
Note: None
This course meets the following Raider Core CLO Requirement: None

Course Learning Outcomes
Upon successful completion of this course, the student will be able to:

Demonstrate an understanding of the role of FDA and international regulatory bodies in the design, development, evaluation, and marketing of medical devices in the United States and globally
Demonstrate an understanding of essential FDA and international regulatory pathways for device premarket approval
Demonstrate an understanding of essential post-market requirements for medical devices in the United States and globally
Demonstrate an understanding of medical device classes and associated risks
Demonstrate an understanding of the Quality System Regulation and Good Manufacturing Practices
Demonstrate familiarity with those standards that address medical device safety and effectiveness (IEC, AAMI/ANSI, NFPA, UL, ISO), and the role of standards in medical device regulation
Demonstrate an understanding of the risk management process and its role in medical device development and regulation
Demonstrate an ability to design basic experiments to assess medical device performance, determine substantial equivalency, and how to properly analyze the statistical results from such experiments using professional statistical software

Prerequisites by Topic

Hypothesis testing
Basic design of experiments
Probability density and distribution functions

Course Topics

Food and Drug Administration and history of regulation in the United States
Regulation of pharmaceuticals vs. medical devices
Medical device definition, intended use and indications for use
Device classification and types
Devices classes and risk definitions
Regulatory controls
Quality System Regulation, Design Controls, and Good Manufacturing Practices
Premarket pathways
- 510(k) Exemption
- Premarket Notification 510(k)
- De Novo
- Premarket Approval (PMA)
- Emergency Use Authorization
- Humanitarian Device Exemption
Postmarket requirements
Medical device standards (IEC, AAMI/ANSI, NFPA, UL, ISO) and their role in medical device regulation.
Regulatory requirements for clinical studies of medical devices
- Investigational Device Exemption
- Institutional Review Board and Informed Consent
- Ethical considerations in clinical studies of medical devices
Risk management and its role in device development and regulation
International regulations of medical devices
Medicare and Medicaid reimbursement and Joint Commission certification of healthcare organizations
Case studies of device development

Coordinator
Dr. Olga Imas

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