Direct comparison
Initial Importer vs Importer of Record: Devices
Initial importer vs importer of record for medical devices: FDA 21 CFR 807.3(g) registration duties versus CBP 19 CFR 101.1 duty liability, side by side.
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How do Initial importer (FDA), Importer of record (CBP) compare side by side?
The table below compares Initial importer (FDA), Importer of record (CBP) across 12 procurement-relevant dimensions, from defined in through source.
Side-by-side comparison
| Dimension | Initial importer (FDA) | Importer of record (CBP) |
|---|---|---|
| Defined in | 21 CFR 807.3(g), FDA establishment registration and listing rules | 19 CFR 101.1, CBP general definitions (the term "importer" lists the importer of record as one of the persons it may be) |
| Core definition | Any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale to the ultimate consumer or user, but does not repackage or otherwise change the container, wrapper or labeling of the device or package | The person primarily liable for payment of any duties on the merchandise, or an authorized agent acting on his behalf; it may be the consignee, the importer of record, an actual owner who has filed the required declaration and bond, or a bonded-warehouse transferee |
| Regulator the role answers to | FDA (device regulation) | CBP (customs and duties) |
| Registration with FDA | An initial importer is among the persons who must register under 21 CFR 807.20(a)(5) | 19 CFR 101.1 is a customs definition and sets no FDA registration duty; FDA registration attaches to the activities listed in 21 CFR 807.20(a) |
| Device listing | May meet its listing obligation for a device it did not develop, repackage or relabel by submitting the manufacturer's name and address; must be ready to give FDA, on request, the proprietary name (if any) and common or usual name of each device | Not a listing concept |
| Entry filing | FDA reviews entries that are filed with CBP and sent to it electronically; the entry itself is filed with CBP | An importer or customs broker is required to submit the required entry information to CBP |
| Other FDA duties named by FDA | FDA's importing page lists establishment registration and Medical Device Reporting (21 CFR 803) among initial-importer obligations | Not part of the definition |
| What the role excludes | Repackaging or changing the container, wrapper or labeling: a person who does that is a repackager or relabeler under 21 CFR 807.20(a)(3) | The definition does not turn on repackaging or labeling |
| Neighbouring role: wholesale distributor | Defined in 21 CFR 807.3(t) as a person other than the manufacturer or the initial importer; registration and listing do not apply to a wholesale distributor that does not manufacture, repackage, process or relabel (21 CFR 807.20(c)) | Not a customs category in 19 CFR 101.1 |
| Can one company hold both roles? | Yes, if it also meets the customs definition: the two definitions are independent | Yes, if it also furthers the marketing of a foreign-made device without changing its labeling |
| When to use each term | Use it when the question is who has FDA registration, listing and device-reporting duties for a foreign-made device | Use it when the question is who is liable to CBP for duties on an entry |
| Source | 21 CFR 807.3 and 807.20 (law.cornell.edu/cfr/text/21/807.3 and /807.20); FDA, Importing Medical Devices and Radiation-Emitting Electronic Products into the U.S. (fda.gov); read 2026-10-31 | 19 CFR 101.1 (law.cornell.edu/cfr/text/19/101.1); FDA importing page for entry filing; read 2026-10-31 |
Common questions
Common questions about Initial importer (FDA) vs Importer of record (CBP)
What is an FDA importer?
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FDA's term for the importer role is initial importer. 21 CFR 807.3(g) defines it as an importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale to the ultimate consumer or user, without repackaging or changing the container, wrapper or labeling.
Is an initial importer the importer of record?
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Not by definition. The initial importer is defined by FDA in 21 CFR 807.3(g); the importer of record is a customs role connected to 19 CFR 101.1, which defines the importer as the person primarily liable for duties. One company can fit both definitions, but meeting one does not establish the other. FDA's importing page does not use the term importer of record.
Does an initial importer need FDA registration?
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Yes. 21 CFR 807.20(a)(5) lists a person who acts as an initial importer among those who must register. For devices it did not develop, repackage or relabel, the initial importer can meet its listing obligation by giving the manufacturer's name and address, and must be prepared to give FDA the proprietary and common names of each device on request.
What is FDA importer registration?
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It is establishment registration under 21 CFR Part 807 for a company that acts as an initial importer. Whether a wholesale distributor must register is a separate question: 21 CFR 807.20(c) says registration and listing do not pertain to a wholesale distributor that does not manufacture, repackage, process or relabel a device.
