585.619.81 - Regulation of Medical Devices

Applied Biomedical Engineering

Spring 2024

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.

Instructors

Course Structure

The course materials are divided into modules which can be accessed by clicking Course Modules on the left menu. The course content for this course is divided into 14 online modules. A module will have several sections including the overview, content, readings, discussions, and assignments. You are encouraged to preview all sections of the module before starting. Each Module runs for a period of seven (7) days (Wednesday morning to Tuesday night), exceptions are noted in the Course Outline. You should regularly check the Calendar and Announcements for assignment due dates.

Course Topics

FDA Organization and History
Regulatory Pathway/Device Classification
Standards and Using Standardized Testing
Risk Analysis/Management
Pre-Markety 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 Sterilzation)
Other Considerations (Labeling and SaMD)
Post-Market Surveillance and Time to Review

Course Goals

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 Learning Outcomes (CLOs)

Explain the significant history and organizing structure of the FDA.
Identify the proper regulatory pathway for a new medical device.
Identify controls and standards for basic types of medical devices.
Explain the entire regulatory process from pre-submission to post-market surveillance.

Textbooks

Not Required.

Student Coursework Requirements

It is expected that each module will take approximately 7–10 hours per week to complete. Here is an approximate breakdown: reading the assigned supplemental readings and participating in the online discussion boards as well

Explain the significant history and organizing structure of the FDA.

Identify the proper regulatory pathway for a new medical device.
Identify controls and standards for basic types of medical devices.
Explain the entire regulatory process from pre-submission to post-market surveillance.

as some outside research (approximately 3–4 hours per week), listening to the audio annotated slide presentations (approximately 2–3 hours per week), and completing the year-long-project milestones (approximately 2–3 hours per week).

This course will consist of four basic student requirements:

Assignments (36% of Final Grade Calculation)
There will be 6 assignments, roughly every 2 weeks in this course. Each assignment is worth 6% of the grade. Please include your name and a page number indicator (i.e., page x of y) on each page of your submissions. All Figures and Tables should be captioned and labeled appropriately. All assignments are due according to the dates in the Calendar. Late submissions will be reduced by one letter grade for each week late (no exceptions without prior coordination with the instructors).
Quizzes (24% of Final Grade Calculation)
There will be 12 quizzes in this course each worth 2% of your grade. All assignments are due according to the dates in the Calendar. Late submissions will be reduced by one letter grade for each week late (no exceptions without prior coordination with the instructors).
Participation (Class Discussion Boards) (10% of Final Grade Calculation) 
Each student is responsible for listening to the lectures and carefully reading all assigned material
to prepare for discussions. Post your initial response to the discussion questions by the evening of day 4 for that module week. Posting a response to the discussion question is part one of your grade for class discussions (i.e., Timeliness). Part two of your grade for class discussion is your interaction (i.e., responding to classmate postings with thoughtful responses; Critical Thinking) with classmates. Just posting your question is not sufficient; we want you to interact with your classmates. Be detailed in your responses to your classmates' questions. Feel free to agree or disagree with your classmates. Please ensure that your postings are civil and constructive. Evaluation of preparation and participation is based on contribution to discussions. Preparation and participation is evaluated by the following grading elements:
1. Timeliness (50%)
2. Critical Thinking (50%)
Preparation and participation is graded as follows:  
10 —Timeliness [regularly participates; all required postings; early in discussion; throughout the discussion]; Critical Thinking [rich in content; full of thoughts, insight, and analysis].  
8 - 9 —Timeliness [frequently participates; all required postings; some not in time for others to read and respond]; Critical Thinking [substantial information; thought, insight, and analysis has taken place].  
6 - 7 —Timeliness [infrequently participates; all required postings; most at the last minute without allowing for response time]; Critical Thinking [generally competent; information is thin and commonplace].  
5 - 6 —Timeliness [rarely participates; some, or all required postings missing]; Critical Thinking [rudimentary and superficial; no analysis or insight is displayed].
Semester-long Mock Submission Project (20% of Final Grade Calculation)
During the span of this course you will complete a mock submission project. In this project you will develop a regulatory strategy for a specific medical device type (not a specific brand). The development and review of this device’s “path to market” will include short written assignments throughout the semester and a short presentation given to your peers at the conclusion of the semester.
Final Exam (10% of Final Grade Calculation)
The final portion of your grade will be determined by a 65min (intended to be ~1min per question), open book final exam. You will have a 7 day window to take this exam through the course Blackboard site. Late submissions will be reduced by one letter grade for each week late (no exceptions without prior coordination with the instructors).

Grading Policy

EP uses a +/- grading system (see “Grading System”, Graduate Programs catalog, p. 10).

Score Range	Letter Grade
100-97	= A+
96-93	= A
92-90	= A−
89-87	= B+
86-83	= B
82-80	= B−
79-77	= C+
76-73	= C
72-70	= C−
69-67	= D+
66-63	= D
<63	= F

Academic Policies

Deadlines for Adding, Dropping and Withdrawing from Courses

Students may add a course up to one week after the start of the term for that particular course. Students may drop courses according to the drop deadlines outlined in the EP academic calendar (https://ep.jhu.edu/student-services/academic-calendar/). Between the 6th week of the class and prior to the final withdrawal deadline, a student may withdraw from a course with a W on their academic record. A record of the course will remain on the academic record with a W appearing in the grade column to indicate that the student registered and withdrew from the course.

Academic Misconduct Policy

All students are required to read, know, and comply with the Johns Hopkins University Krieger School of Arts and Sciences (KSAS) / Whiting School of Engineering (WSE) Procedures for Handling Allegations of Misconduct by Full-Time and Part-Time Graduate Students.

This policy prohibits academic misconduct, including but not limited to the following: cheating or facilitating cheating; plagiarism; reuse of assignments; unauthorized collaboration; alteration of graded assignments; and unfair competition. Course materials (old assignments, texts, or examinations, etc.) should not be shared unless authorized by the course instructor. Any questions related to this policy should be directed to EP’s academic integrity officer at ep-academic-integrity@jhu.edu.

Students with Disabilities - Accommodations and Accessibility

Johns Hopkins University values diversity and inclusion. We are committed to providing welcoming, equitable, and accessible educational experiences for all students. Students with disabilities (including those with psychological conditions, medical conditions and temporary disabilities) can request accommodations for this course by providing an Accommodation Letter issued by Student Disability Services (SDS). Please request accommodations for this course as early as possible to provide time for effective communication and arrangements.

For further information or to start the process of requesting accommodations, please contact Student Disability Services at Engineering for Professionals, ep-disability-svcs@jhu.edu.

Student Conduct Code

The fundamental purpose of the JHU regulation of student conduct is to promote and to protect the health, safety, welfare, property, and rights of all members of the University community as well as to promote the orderly operation of the University and to safeguard its property and facilities. As members of the University community, students accept certain responsibilities which support the educational mission and create an environment in which all students are afforded the same opportunity to succeed academically.

For a full description of the code please visit the following website: https://studentaffairs.jhu.edu/policies-guidelines/student-code/

Classroom Climate

JHU is committed to creating a classroom environment that values the diversity of experiences and perspectives that all students bring. Everyone has the right to be treated with dignity and respect. Fostering an inclusive climate is important. Research and experience show that students who interact with peers who are different from themselves learn new things and experience tangible educational outcomes. At no time in this learning process should someone be singled out or treated unequally on the basis of any seen or unseen part of their identity.

If you have concerns in this course about harassment, discrimination, or any unequal treatment, or if you seek accommodations or resources, please reach out to the course instructor directly. Reporting will never impact your course grade. You may also share concerns with your program chair, the Assistant Dean for Diversity and Inclusion, or the Office of Institutional Equity. In handling reports, people will protect your privacy as much as possible, but faculty and staff are required to officially report information for some cases (e.g. sexual harassment).

Course Auditing

When a student enrolls in an EP course with “audit” status, the student must reach an understanding with the instructor as to what is required to earn the “audit.” If the student does not meet those expectations, the instructor must notify the EP Registration Team [EP-Registration@exchange.johnshopkins.edu] in order for the student to be retroactively dropped or withdrawn from the course (depending on when the "audit" was requested and in accordance with EP registration deadlines). All lecture content will remain accessible to auditing students, but access to all other course material is left to the discretion of the instructor.