Review registration and listing by business role

Map the actual supply chain

Record who manufactures, specifies, repacks, relabels, imports and distributes the device, and what each establishment actually does. Duties can differ by establishment type and activity. A contract manufacturer, a private-label brand and an initial importer should not all rely on a single supplier certificate without checking their own roles.

For a foreign establishment, review the U.S. agent requirement where applicable and the accuracy of the associated records. Keep the responsible party, facility address, device listing information, current status and applicable fee or renewal evidence together. An agent arrangement does not itself resolve importer obligations or establish that a device may be marketed.

Check registration separately from the pathway

Match the listing to the specific device and the correct establishment role. Separately verify the applicable 510(k), De Novo, PMA or exemption evidence. A registration number on a label or a commercial registration certificate does not prove FDA approval. Record which official source was checked, when, and which exact role or product it supports.

For example, importing an already marketed device under a new brand may involve relabeling, listing, authorization and labeling questions. Ask what changed and who assumes each role; do not simply copy the original manufacturer’s number. Keep registration evidence versioned with the commercial agreement, released artwork and device identity.

What to declare in the free pre-check

Mark establishment registration or device listing only after you have the supporting records and have considered applicability. An unchecked item creates a preparation prompt, not a legal finding. Checking the item records your declaration and cannot replace a database verification, renewal review, supply-chain assessment or marketing authorization.

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 how to register and list
• FDA overview of device regulation
• FDA device labeling

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