Labeling Requirements for Medical Devices in the US E-Learning with WMDO

This course provides a detailed review of the labeling requirements for medical devices in the US.

The content of this course is based on the Code of Federal Regulations (CFR) and the following guidance documents:

• FDA Guidance G91-1: “Device Labeling Guidance”
• FDA Guidance 89-4203: “Labeling: Regulatory Requirements for Medical Devices”
• Guidance on medical device patient labeling
• Guidance for industry and FDA reviewers (19 April 2001)
• General device labeling 21 CFR 801

The final part of this focuses on recommendations from the SME.

To enroll and purchase this course, please visit the WMDO website at: http://www.wmdo.org/SGS.aspx

Upon successfully completing this course, learners will be able to:

• Plan labeling activities for the US market
• Apply regulations and guidance documents to the labeling process
• Support development of device labeling
• Apply different requirements for OTC, prescription devices, and restricted devices
• Evaluate compliance with regard to misbranding