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?