Print Version

Effective: Summer 2014

Grade Type: Letter Grade, the student may select Pass/No Pass
Not Repeatable.
FHGE: Non-GE Transferable: CSU
5 hours lecture. (60 hours total per quarter)

Student Learning Outcomes -
  • Students who successfully complete this course should be able to classify a medical device based on the level of control needed to assure safety and effectiveness.
  • Students who successfully complete this course should be able to identify major requirements of Good Manufacturing Processes.
Description -
Introduction to certification standards and the agencies involved in the regulatory processes specific to the medical device industry. Topics include Food and Drug Administration regulations, international regulations and quality certification processes.

Course Objectives -
The student will be able to:
  1. Explain FDA regulation and medical device amendments
  2. Explain International regulations: Europe, Canada, Japan and Australia
  3. List device classification
  4. Explain Good Manufacturing Processes
  5. Explain Good Clinical Processes
  6. Explain Good Lab Processes
  7. Explain considerations in medical device testing
Special Facilities and/or Equipment -

Course Content (Body of knowledge) -
  1. Premarket clearance of medical devices
  2. The medical device amendments of 1976
    1. Definition of a medical device
    2. The medical device reclassification process
    3. The classification system
    4. Classification of Pre-amendment devices
    5. FDA's device classification, 1973-1988
    6. Continuing classification devices
  3. Marketing a medical device
    1. 510(k) notification process
    2. PMA process
    3. PDP process
    4. Reclassification
    5. De Novo review
  4. General principles of marketing clearance/approval
    1. Reasonable safety and effectiveness
    2. Substantial equivalence
  5. The Safe Medical Devices Act of 1990
    1. The SMDA
    2. MDA 1992
  6. The impact of the Food and Drug Administration Modernization Act of 1997 and the approval process
  7. MDUFMA 2002
    1. User fees
    2. Performance goals
    3. Office of combination products
    4. Modular PMA review
    5. Processed single use devices
    6. Inspections by accredited third parties
    7. Manufacturer identification
  8. The Food and Drug Administration Amendment Act of 2007
    1. User fees
    2. MDUFMA 2007 substantial changes
    3. Pediatric device act
    4. Reagan-Udall and advisory panels
    5. Clinical trial registry
  9. CDRH Organizational structure
Methods of Evaluation -
  1. Midterm exams comprised of objective and/or written sections and which require critical thinking and analysis of course readings
  2. Final exam requiring knowledge and analysis of all information gathered during the course
  3. Oral presentation
  4. Written expression in evaluating course topics and which require integration of scientific principles with societal/personal views
Representative Text(s) -
Pisano D., FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, 2nd edition, 2008 (latest edition).

Disciplines -
Method of Instruction -
Lecture, group discussion.
Lab Content - No content
Types and/or Examples of Required Reading, Writing and Outside of Class Assignments -
  1. Reading Assignments
    1. Weekly reading assignments from text and outside sources
    2. Suggested supplemental readings from articles relevant to course material
    3. Suggested supplemental reading of case studies
    4. Suggested supplemental readings from web searches relevant to course material
    5. Weekly discussions based on reading assignments and which require knowledge and integration of course material
  2. Writing Assignments
    1. Question sets based upon assigned reading on current research topics
    2. Weekly computational problem sets