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 publication 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, and Cosmetic (FD&C) Act, which was signed into law in 1938. The objective of the FD&C Act was to ensure the safety of drug products commercialized in the US and the law 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 specifically regulate those products that are today categorized as medical devices. The Medical Device Amendments (MDA) of 1976 provided the basis for many aspects of current US medical device regulation, from development and manufacturing through commercialization.
This course is intended to provide a basic overview 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 US Food and Drug Administration (FDA) for approval (or clearance) to market a device, and finally addresses postmarket requirements. This course also discusses device classification, as well as how to select the appropriate FDA application for the device and other general device controls (including labeling, establishment registration and listing, quality system regulations, adverse event and correction and removal reporting).
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 medical device
- Understand FDA interaction within the agency itself, with other US government agencies and with device manufacturers
- Describe types of device submissions, their requirements and uses and how to select the most appropriate one
- Describe and explain the regulation of advertising, promotion and labeling
- Understand postmarketing requirements, including those sometimes imposed by FDA, as a condition of marketing approval
Target Audience
This course is intended for new regulatory professionals and those in related departments interested in understanding the basics of US medical device regulation.