Title: A Regulated Industry
Course: BTEC-1300-301-302-303-F21 > Section: Regulations and Medical Devices

Welcome to BTEC 1300. This course is an introduction to a regulated manufacturing environment. By regulated we mean an industry that is overseen by the Food and Drug Administration, such as medical device manufacturing, pharmaceuticals, and dietary supplements.

This module covers how and why industry is regulated by the Food and Drug Administration.

In this module you’ll learn

- how the Food and Drug Administration regulates biotechnology manufacturing,
- where the FDA derives its authority,
- what a medical device is,
- how medical devices are classified,
- how other regulatory bodies, including the International Organization for Standardization, regulate biotechnology manufacturing,
- how the FDA inspects biomanufacturing facilities and enforces its regulations, and
- why the FDA regulations are important.