This document applies to all medical devices, including IVD medical devices, and is intended to specify the general content and format of medical device and IVD medical device labeling in paper or electronic format. This document provides general labeling principles, including specific sections on the label, instructions for use, and information intended for the patient.
The requirements of any relevant medical device or IVD medical device-specific standards should also be considered.
While this document includes general labeling principles, it does not include sections that address other possible elements of labeling. Advertising and promotional materials may be considered elements of labeling by some RAs having jurisdiction, but they are outside the scope of this document. Individual jurisdictions may have their own regulations or requirements regarding other labeling elements or advertising and promotional materials.