Keep regulatory ownership clear
The FDA’s UDI system addresses identification of medical devices through distribution and use. Device-specific obligations and direct-marking applicability need to be determined by the responsible labeler or regulatory team. Give the marking supplier the approved requirements rather than asking it to infer them from a product photograph or a generic request for a “medical code.”
Provide the approved data and acceptance plan
Identify the encoded content, symbology, human-readable information and mark area. Specify the material, final surface condition and any required verification or validation. Explain how cleaning or reprocessing requirements will be assessed by the responsible team. An attractive sample is not a substitute for the device manufacturer’s required validation.
Control production and changes
Define how released data reaches the supplier and how completed parts and records are reconciled. Treat changes to geometry, material, finish or code content as controlled changes. The supplier should know when a new approval is required. Keep inspection and traceability records connected to the relevant part and production release. Consult the current FDA guidance and applicable requirements for the specific device.