Description
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
Objectives
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
Audience
Who Should Enroll:
Regulatory affairs professionals in charge of labeling, developmental engineers and clinical research managers who contribute to the setup of medical device labeling, and quality managers and engineers who are responsible for change control of technical documents (including labeling) are all welcome to participate in this course.
Prerequisite Knowledge/Requirements:
A strong comprehension of the pre-market notification (510k) and pre-market approval process for market access in the US is required. Knowledge of the principles of risk management processes, including human factors, engineering requirements, and impacting labeling is also required for this course.
For more information on the topics above, please review the following courses:
- Risk Management for Medical Devices in EU and US (ID 77)
- US FDA 510(k) Notification Process (ID 92)
- US FDA Investigational Device Exemption (IDE) Overview (ID 121)