Does the U.S. FDA UDI Rule apply to hospitals?

The U.S. FDA UDI Rule applies to “labelers” of medical devices. If a hospital acts as a “labeler” within the
definition of the U.S. FDA UDI Rule, then the hospital has to comply with the rule. Consult with your
compliance team for more information about your hospital and activities. Nonetheless, hospitals will have
to be prepared to work with these new identifiers as well as leverage the new GUDID (database) content
for recalls and more.