The commercialization of food and drug products has been regulated in the US since the early 20th century. Passage of the Pure Food & Drug Act of 1906 was partly prompted by the publishing of Upton Sinclair’s famous work The Jungle, which described in detail many horrors associated with the American meatpacking industry at the time. Passage of this legislation paved the way for development of the landmark Food, Drug & Cosmetic (FD&C) Act, which was ratified in 1938. The objective of the FD&C Act was to ensure the safety of drug products commercialized in the US and was a major step forward in regulating products used in clinical settings.
Development and commercialization of medical device products was not, however, a specific objective of the FD&C Act. In fact, it was not until 1976 that the first major piece of US legislation was enacted to regulate those products that are today categorized as medical devices. The Medical Device Amendments of 1976 (MDA) provided the basis of many aspects of current US medical device regulation, from development through manufacturing through commercialization.
This course provides a basic understanding of US medical device regulation. It covers a wide range of issues, from the history of medical device regulation through the steps required to submit an application to the Food and Drug Administration (FDA) for approval to market a device through postmarket requirements. This course also discusses device classification as well as electing the appropriate FDA application for the device, including labeling, establishment registration and listing.
Learning Objectives
Upon completion of this course, participants should be able to:
- Define a medical device and understand the FDA regulations surrounding commercialization of a device
- Describe FDA interaction within the agency itself, with other US government agencies and with device manufacturers
- Identify and describe types of device submissions
- Describe and explain the regulation of advertising, promotion and labeling
- Elucidate postmarketing requirements, including those sometimes imposed by FDA as a condition of marketing approval
Target Audience
This course is intended for new regulatory affairs professionals and those in related departments interested in understanding the basics of US medical device regulation.