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Recorded Webinar
FDA Labeling Requirements for Medical Devices
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
FDA regulates all labeling for medical devices. This webcast outlines the general labeling requirements for all medical devices – including over-the-counter devices, IVD devices, investigational devices, and electronic/radiation-emitting devices. The webinar explains concepts such as “label” vs. “labeling”, “adequate directions for use”, “claims”, “intended use”, “indications for use”, and “off-label use”. It includes short discussions of electronic labeling UDI (Unique Device Identifier) requirements, advertising/promotion of medical devices using product claims and promotional claims, and off-label use of devices.
Areas Covered in the Webinar:
- FDA requirements
- UDI, Standardized Date Format, GUDID
- Claims – product claims and promotional claims
- Intended Use and Indications for Use
- Off-label use – What is it? When is it OK to distribute information on off-label use?
Who should attend
Anyone who is involved in labeling activities, especially sales & marketing, and QA/RA. Anyone interested in an overview of the FDA’s labeling requirements.
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