What belongs in line clearance minutes?

Every person-minute spent opening and closing the run. That covers clearing the last run's labels, issuing and counting labels, checking the first label against the approved master and reconciling use.

How do I count labels per device when a box holds several devices?

Divide each shared label by the devices it covers and add them up. A pouch label on every device, a shelf box of 10 and a case of 100 give 1 + 0.1 + 0.01 = 1.11 labels per device.

Why is the all-in cost per label so far above the label price?

Because handling and line clearance are spread over the labels too. At the defaults, $0.15 of stock and ribbon becomes $0.362: handling adds $0.167 and line clearance $0.045.

Does FDA require labels to be inspected before use?

Yes: section 820.45 of FDA's quality management system regulation requires labeling to be examined for accuracy and inspected before use to prevent mixups, with results documented.

MedTech Manufacturing calculator

Traceability Label Cost Calculator

Price the lot, unit and box labels a production run needs before you quote a build or set its standard cost. You need devices, labels per device, label cost, handling time, line clearance minutes and your burdened rate.

What this calculator does

Cost of the traceability labels on one production run, per device and per label, from label counts, handling time and line clearance.

Formula used

Labels per run = devices per run × labels per device
Label and ribbon cost = labels per run × label and ribbon cost per label
Print, verify and apply cost = labels per run × seconds per label ÷ 3,600 × burdened hourly rate
Line clearance cost = line clearance minutes ÷ 60 × burdened hourly rate
Label cost per run = sum of the three costs; label cost per device = label cost per run ÷ devices

Inputs explained

Devices per Run: Devices labeled in this production run, from the work order.
Labels per Device: Unit label, plus each box and case label divided by devices inside.
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.
Line Clearance Minutes per Run: Line clearance, label issue, first-label check and reconciliation, in person-minutes.
Burdened Hourly Rate: Wage plus benefits and overhead for the labeling operator.

How to use the result

Best suited to setting labeling standard cost for a new device, setting a minimum run size per label set, justifying a print and apply labeler.
Printer, verifier and label software depreciation, artwork changes and label storage 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

What belongs in line clearance minutes? Every person-minute spent opening and closing the run. That covers clearing the last run's labels, issuing and counting labels, checking the first label against the approved master and reconciling use.
How do I count labels per device when a box holds several devices? Divide each shared label by the devices it covers and add them up. A pouch label on every device, a shelf box of 10 and a case of 100 give 1 + 0.1 + 0.01 = 1.11 labels per device.
Why is the all-in cost per label so far above the label price? Because handling and line clearance are spread over the labels too. At the defaults, $0.15 of stock and ribbon becomes $0.362: handling adds $0.167 and line clearance $0.045.
Does FDA require labels to be inspected before use? Yes: section 820.45 of FDA's quality management system regulation requires labeling to be examined for accuracy and inspected before use to prevent mixups, with results documented.

Last reviewed 2026-10-01.