The Food and Drug Administration (FDA) is issuing this guidance to announce that both the list of devices subject to medical device tracking requirements.

The Food and Drug Administration (FDA) is issuing this guidance to announce that both the list of
devices subject to medical device tracking requirements, and the list of medical devices released
from tracking requirements, have been updated. This updated guidance identifies all affected
devices (those tracked and those released from tracking) in table format. The table includes two
fields to describe each device: (1) product code (procode) and (2) the standardized procode
definition (product code – preferred term). These two descriptive fields are intended to provide
clarity about which devices are tracked. The product code and preferred name are generally found in
the approval or clearance letter issued by CDRH.
FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidance describes the Agency’s current thinking on a topic and should be
viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The
use of the word should in Agency guidance means that something is suggested or recommended,
but not required.