U.S. medical device label preparation checklist

How to use the checklist

Start with one device model and the exact configuration sold in the United States. Gather the specification, classification rationale, pathway evidence, instructions, risk-control records, business roles and final artwork before checking items. Where a duty is not applicable, keep the specific basis separately. An empty checkbox is an open question, not proof of a legal violation.

Leave an item unmarked if information is missing, contradictory or belongs to another device version. A count of twelve marked items is not a compliance pass. Record the reviewer, source, decision, date and artifact revision outside this tool. Reset and repeat after changes in intended use, design, supplier, business role, package or claim.

Worked example: a relabeled monitor

A seller obtains a supplier’s monitor and replaces the outer carton with its own brand. Before marking the checklist, reconcile the model and indication with the pathway record; identify relabeler and importer duties; compare all instructions and warnings; assess UDI responsibility; and inspect the assembled package. A supplier screenshot or a working barcode alone cannot settle those decisions.

Use the focused guides below to resolve the relevant evidence questions. The product pre-check accepts declarations and exact text that you verify yourself; automatic image uploads have not met the full-label reliability target. Neither workflow validates performance testing, clinical evidence, quality-system implementation or an FDA decision.

Keep evidence and decisions separate

Keep the original evidence and the released device version together. When a source or fact is uncertain, record the open question instead of converting it into a pass. Official database references and this checklist do not substitute for a device-specific decision.

Official starting points for this topic

• FDA device labeling
• FDA overview of device regulation
• FDA Quality Management System Regulation

FDA page topics were checked on October 7, 2026. Linked regulations and database records still need product-specific applicability review; public links do not establish that a device is authorized.

Continue the device review