Course Details

Medical Devices: Regulation & Compliance

This course will examine the regulation of medical devices and the interplay of statutory law, industry standards, and regulatory agency guidance. We will explore Food and Drug Administration (FDA) regulations; requirements for the development, manufacturing, and distribution of these products; and compliant interactions between industry and physicians (and other healthcare providers. We will also look at healthcare fraud and abuse, including the anti-kickback statute. The course will cover the regulatory and compliance considerations for: • Bringing a medical device to market for the first time • Keeping that medical device product on the market • Compliance considerations in the sales and marketing of medical devices • Expanding sales and marketing of the device into other geographies While the primary focus will be on the US to establish a foundation, the course also will provide insight to medical device regulation and compliance globally. Additionally, where appropriate, a comparison of medical devices to other regulated products such as drugs and biologics will be highlighted.

Catalog Number: REGLAW 940-0
Additional Course Information: MSL students only


Course History

Spring 2020
Title: Regulation of Drugs, Devices & Biologics
Faculty: Followell, Valerie A
Ford, Ann K
Section: 1     Credits: 1.0
Capacity: 32     Actual: 29

Spring 2019
Title: Regulation of Drugs, Devices & Biologics
Faculty: Bierig, Jack R
Section: 1     Credits: 1.0
Capacity: 35     Actual: 23

Spring 2018
Title: Regulation of Drugs, Devices & Biologics
Faculty: Bierig, Jack R
Section: 1     Credits: 1.0
Capacity: 45     Actual: 30

Spring 2017
Title: Regulation: Medicine & Health
Faculty: Wojcik, Jerzy
Section: 1     Credits: 1.0
Capacity: 20     Actual: 13