Introduction to U.S. Device Regulation

This is the first mini-course of the CERSI "Regulatory Overview of Medical Device Development". In this mini-course, you will learn the basics of U.S. regulation of medical devices. The course will initially cover the general context for medical device regulations. FDA's regulations, guidance documents, and on-line informational resources will be highlighted and used throughout the course. Upon completion of this mini-course, students will be able to:

• describe how medical devices are defined
• name required features and characteristics of medical devices
• name national and international agencies with a regulatory oversight for medical devices
• explain and use FDA regulatory framework and web site
• discuss some of the future trends in regulation of medical devices
• describe the steps needed to obtain approval to market a medical device
• describe how medical devices are assigned to regulatory classes
• use FDA’s web site to classify a device and determine its regulatory history
• describe the four major device regulatory pathways
• explain the impact of regulatory pathways on medical device development
• describe the major phases of the Medical Device Life Cycle
• name four important elements of the Quality System Regulation
• explain the intent of the Design Controls regulation and when it applies
• describe general principles used to guide the medical device development process
• describe the FDA regulations applicable to feasibility studies

Statement of Completion

Students who attend the on-site mini-course and pass the on-line quiz will receive a Statement of Completion from UCSF-Stanford CERSI.

Agenda for this mini-course

1. Lecture 1. Introduction to Device Regulation
2. Lecture 2. Regulatory Pathways to Market a Device
3. Lunch Break
4. Lecture 3. Overview of Medical Device Development Cycle
5. Case Study.

Who should attend

This mini-course will be most valuable to students and professionals who need an understanding of how to get medical devices into the US market while respecting FDA regulations. The course is geared toward entry level students who need to gain an understanding of submissions for the first time. Engineers, managers, supervisors, scientists, technicians, and other personnel involved in product development, manufacturing, quality assurance, or regulatory affairs that do not have an in-depth knowledge of medical device submissions will benefit from this course.

Instructor

Michael D. Quinn is a management adviser for early stage medical device companies helping to guide product development and build company infrastructure. Over the course of his career, he developed numerous medical products as an engineer and helped start new companies as an entrepreneur and executive team member. He began his career with Edwards Laboratories, now Edwards Lifesciences, where he developed catheters and instrumentation to improve cardiovascular monitoring. Later he joined Nellcor, now part of Medtronic, and expanded their pulse oximetry and respiratory monitoring products. More recently, he helped launch several medical device companies as Vice President, Research and Development. His consulting activities include developing regulatory strategies, quality systems, and funding strategies. Product areas include cancer diagnostics, diabetes management, inhalation drug delivery and imaging-based cell counters. He earned a B.S. in Electrical Engineering from the University of Massachusetts, and M.S. and Ph.D. degrees in Biomedical Engineering from the University of Southern California.