Instructor Information
Arielle Drummond
Dr. Drummond is a lecturer in Applied Biomedical Engineering at Johns Hopkins University. She holds a Ph.D. in Biomedical Engineering from Carnegie Mellon University where her research focused on the development of a surgical planning tool for pediatric ventricular assist devices. After completing her doctorate, she worked for Medtronic and CircuLite, where she was responsible for developing implantable cardiovascular medical devices. She is currently a Director of Regulatory Affairs at LivaNova.
Course Information
Course Description
Biomedical engineers are uniquely involved in many aspects of product development, from the inception of the idea to its delivery in the marketplace. This course will cover one major aspect of that process—the objectives and mechanisms of the FDA regulatory system governing the clinical use of medical devices in the United States, including regulatory pathways and device classification. Students will both analyze and discuss management of risk, and they will design controls related to cardiovascular, orthopedic, and neurological devices. By the end of the course, students will have a deep understanding of how the regulatory process is involved in every phase of medical device development.
Course Goal
To understand the function and organization of the Food and Drug Administration (FDA) related to the regulation of medical devices. The course will highlight the FDA’s role in medical device regulation in regards to pre-market review of medical devices, but will also touch upon aspects of the Agency’s role in post-market device compliance and the design and execution of medical device clinical trials in the United States.
Course Objectives
By the end of the course, you will be able to:
- Explain the significant history and organizing structure of the FDA.
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Identify the proper regulatory pathway for a new medical device.
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Identify controls and standards for basic types of medical devices.
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Explain the entire regulatory process from pre-submission to post-market surveillance.
When This Course is Typically Offered
This course is typically offered in the spring term online.
Syllabus
- FDA Organization and History
- Regulatory Pathway/Device Classification & the Pre- Submission Program
- Standards and Using Standardized Testing
- Risk Analysis/Management & Design Controls
- Pre-Market Notification 510(k) & De Novo
- Orthopedic Case Studies
- Investigational Device Exemption (IDE) and Early Feasibility Studies
- Neurological and Physical Medicine Case Studies
- Pre-Market Approval (PMA) & Humanitarian Device Exemptions (HDE)
- Cardiovascular Case Studies
- Other Considerations (Biocompatibility and Sterilization)
- Other Considerations (Labeling and Digital Health)
- Post-Market Surveillance and Time to Review
- Course Wrap-up and Final Exam
Student Assessment Criteria
| Class Preparation and Participation | 10% |
| Homework Assignments | 36% |
| Class Project | 20% |
| Quizzes | 24% |
| Final Exam | 10% |
Assignments are due according to the dates posted in your Blackboard course site. You may check these due dates in the Course Calendar or the Assignments in the corresponding modules. We will post grades one week after assignment due dates.
We generally do not directly grade spelling and grammar. However, egregious violations of the rules of the English language will be noted without comment. Consistently poor performance in either spelling or grammar is taken as an indication of poor written communication ability that may detract from your grade.
A grade of A indicates achievement of consistent excellence and distinction throughout the course—that is, conspicuous excellence in all aspects of assignments and discussion in every week.
A grade of B indicates work that meets all course requirements on a level appropriate for graduate academic work. These criteria apply to both undergraduates and graduate students taking the course.
EP uses a +/- grading system (see “Grading System”, Graduate Programs catalog, p. 10). You should contact your Program Chair for guidance on the breakdown used by your program.
100–98 = A+ 97–94 = A 93–90 = A− 89–87 = B+ 86–83 = B 82–80 = B− 79–70 = C <70 = F
Textbooks
Textbook information for this course is available online through the MBS Direct Virtual Bookstore.
Course Notes
There are no notes for this course.
(Last Modified: 11/09/2019 05:55:45 PM)