Duration: 70 minutes
This course provides regulatory and quality professionals with a detailed review of the labeling requirements for medical devices applicable in the USA. The contents of this course are based on the applicable code of federal regulations (CFR) and guidance as e.g.:
21 CFR 801 - General Device Labeling
FDA Guidance #G91-1 Device Labeling Guidance (blue book memo)
Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers April 19, 2001
FDA Guidance 89-4203 Labeling - Regulatory Requirements for Medical Devices
Recommendations made by the SME conclude the course.