Medical devices sold within the United States must comply with the labeling requirements contained in 21 CFR Part 801. This course introduces the FDA regulations for medical device labeling, and includes critical aspects to ensure compliance. Additional topics include strategies for best practices, and how labeling fits into the product lifecycle.
Participants in this course will learn:
• The importance of the FDA and regulating medical devices
• FDA regulations for labeling
• How labeling fits in the product lifecycle
• The different types of labeling and label content
• Labeling best practices
This course is available online, and can be taken anytime, anywhere.
