Which packages need their own UDI label?

The label of every device and every device package must bear a UDI under FDA's section 801.20. Single-use devices of one model stored and sold together in one labeled package are excepted individually, but implants never are.

What goes in UDI fixed cost per period?

Costs that do not change with label count: GUDID record entry and updates, verifier calibration and label software. Section 830.330 requires GUDID data for each new device and an update whenever that data changes, so launches and label changes raise it.

Must the UDI appear as both a barcode and text?

Yes: section 801.40 requires easily readable plain text and an automatic identification and data capture form, such as a linear or 2D barcode. Handling time should cover checking both.

Why does cost per device jump in a launch month?

Because fixed UDI cost lands in one period while volume is still low. Each new model or new device package needs a new device identifier under section 830.50, and each identifier needs its own GUDID record.

MedTech Manufacturing calculator

UDI Label Cost per Device Calculator

Find what UDI labeling costs per released device before you set standard cost or add a package level. You need released devices, UDI labels per device, label cost, handling time, your burdened rate and fixed UDI cost.

What this calculator does

UDI cost per released device from the labels that carry it, print and verify time, and fixed GUDID and verifier cost.

Formula used

UDI labels per period = released devices × UDI labels per device
Label and ribbon cost = UDI labels × label and ribbon cost per label
Print, verify and apply cost = UDI labels × seconds per label ÷ 3,600 × burdened hourly rate
UDI cost per period = label and ribbon cost + print, verify and apply cost + UDI fixed cost
UDI cost per device = UDI cost per period ÷ released devices

Inputs explained

Released Devices per Period: Devices released to stock in the period, from the release log.
UDI Labels per Device: Each package level bearing a UDI, divided by the devices it holds.
Label and Ribbon Cost per Label: Label stock plus thermal transfer ribbon per print, from purchase prices.
Print, Verify and Apply Time per Label: Operator time per label from a time study, including scan verification.
Burdened Hourly Rate: Wage plus benefits and overhead for the labeling operator.
UDI Fixed Cost per Period: GUDID record work, verifier upkeep and label software for the period.

How to use the result

Best suited to adding UDI cost to a device's standard cost, pricing an extra labeled package level, budgeting GUDID work for a product launch.
Direct marking of reusable devices, printer and verifier purchase, and label artwork changes are not included.

Current U.S. benchmarks

U.S. manufacturing runs at 75.7% of capacity with new factory orders at $663B per month (Federal Reserve and Census, Aug 2026).
The U.S. has 8,825 medical equipment and supplies establishments employing about 308,388 workers (Census County Business Patterns, 2023).

Common questions

Which packages need their own UDI label? The label of every device and every device package must bear a UDI under FDA's section 801.20. Single-use devices of one model stored and sold together in one labeled package are excepted individually, but implants never are.
What goes in UDI fixed cost per period? Costs that do not change with label count: GUDID record entry and updates, verifier calibration and label software. Section 830.330 requires GUDID data for each new device and an update whenever that data changes, so launches and label changes raise it.
Must the UDI appear as both a barcode and text? Yes: section 801.40 requires easily readable plain text and an automatic identification and data capture form, such as a linear or 2D barcode. Handling time should cover checking both.
Why does cost per device jump in a launch month? Because fixed UDI cost lands in one period while volume is still low. Each new model or new device package needs a new device identifier under section 830.50, and each identifier needs its own GUDID record.

Last reviewed 2026-10-01.