US FDA Requirements for Medical Products Labeling / UDI

Medical device and pharmaceutical manufacturers must incorporate in their quality assurance (QA) program several elements that relate to labeling in order to meet the Good Manufacturing Practice (GMP) requirements of the law (21 CFR XXX. The QA program must be adequate to ensure that labeling meets the GMP products master record requirements with respect to content, legibility, placement,adhesion, etc., and ensure that labeling operations are controlled so that correct labeling is always issued and used. Labeling includes equipment labels, control labels, package labels, directions for use, maintenance manuals, etc. The displays on CRT's and other electronic message panels are also considered labeling if instructions, prompts, cautions, and parameter identification information are given. And recent UDI / GUDID requirements add another level of requirements.