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Graduate Course Proposal Form Submission Detail - EIN6273

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Current Status: Approved, Permanent Archive - 2005-05-04
Submission Type:
Course Change Information (for course changes only):

  1. Department and Contact Information

    Tracking Number Date & Time Submitted
    1884 2005-01-20
    Department College Budget Account Number
    Industrial and Mangement Systems Engineering EN 2103-000-00
    Contact Person Phone Email
    Prof. Dolores K. Gooding 45582

  2. Course Information

    Prefix Number Full Title
    EIN 6273 Regulated Product Approval Process

    Is the course title variable? N
    Is a permit required for registration? N
    Are the credit hours variable? N
    Is this course repeatable?
    If repeatable, how many times? 0

    Credit Hours Section Type Grading Option
    3 C - Class Lecture (Primarily) R - Regular
    Abbreviated Title (30 characters maximum)
    Reg Product Approval Process
    Course Online? Percentage Online


    Overview Regulated Industries or by permission of Instructor



    Course Description

    The course provides students with information to collaborate effectively with the FDA to navigate the product approval process, emphasizing medical devices. The underlying scientific, regulatory and quality processes for submission will be reviewed.

  3. Justification

    A. Please briefly explain why it is necessary and/or desirable to add this course.

    This course teaches a vital component of regulatory affairs specifically in medical device manufacturing environments. Major topics related to the review of medical device design and manufacture, substantiated by extensive documentation of the scientific,

    B. What is the need or demand for this course? (Indicate if this course is part of a required sequence in the major.) What other programs would this course service?

    This course serves as an elective in the MS in Engineering Management program, and MS and PhD programs in Biomedical Engineering. It is also a required course in the Graduate Certificate in Regulatory Affairs.

    C. Has this course been offered as Selected Topics/Experimental Topics course? If yes, how many times?

    No. This course has not been offered previously.

    D. What qualifications for training and/or experience are necessary to teach this course? (List minimum qualifications for the instructor.)

    The instructor should possess the following qualifications at a minimum:

    A master's degree in Industrial Engineering or other technical discipline, plus experience in a relevant technical environment with a focus in regulatory affairs. An individual with an earned PhD with the above listed expertise is preferred.

  4. Other Course Information

    A. Objectives

    The course provides students with information to collaborate effectively with regulatory agencies to navigate the product approval process, with particular emphasis on medical devices. Each phase of this technical process will be analyzed including the extensive documentation provided to the regulatory agencies and the integrity of the scientific, regulatory and quality processes to be reviewed. Thorough comprehension and application of the techniques presented will improve the probability of approvals for products of varying complexity for commercialization.

    B. Learning Outcomes

    At the end of the course the student will: Understand the various categories of medical devices and the corresponding process required for approval; Completely describe the Pre-Market Notification (501(k)) application process; Completely describe the Pre-Market Approval (PMA) application process; Understand the most successful methods of managing the relationship with the regulatory agency;

    C. Major Topics

    Application Methods and Contents; Early Collaboration; Determination of Safety and Effectiveness; Investigational Device Exemption; 510(K) - Substantial Equivalence Determination; 510(K) Types - Traditional, Abbreviated, Special; Data Analysis; Pre-Market Approval Application Process; Product Development Protocol; FDA Action On a PMA; Post-Approval Requirements;

    D. Textbooks

    Development of FDA-regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices; Author: Elaine Whitmore; Publisher: ASQ Quality Press; Reference website:;

    E. Course Readings, Online Resources, and Other Purchases

    F. Student Expectations/Requirements and Grading Policy

    G. Assignments, Exams and Tests

    H. Attendance Policy

    I. Policy on Make-up Work

    J. Program This Course Supports

  5. Course Concurrence Information

- if you have questions about any of these fields, please contact or