FDA Registration and Listing for Distributors

General regulatory information from FDA and the Code of Federal Regulations, not legal or regulatory advice. Facts below are as described on the official pages and in the regulations as read on 2026-11-07.

Short answer: a wholesale distributor that is not the manufacturer or the initial importer and does not repackage, relabel or otherwise process the device does not register or list under 21 CFR 807.20(c). The exemption is lost by what the establishment does, not by what it is called: an initial importer, a repackager, a relabeler or a specification developer must register, and most must also list devices.

What it is and who runs it

Establishment registration and device listing are the FDA requirements under 21 CFR Part 807 by which owners or operators of establishments involved in the production and distribution of medical devices intended for commercial distribution in the United States tell FDA where they operate and which devices they handle. FDA’s Center for Devices and Radiological Health (CDRH) runs the process through its online registration system (FURLS) and the Device Facility User Fee (DFUF) site for payment. FDA’s page states that registration is annual and that, generally, establishments that register also list the devices made there and the activities performed on them. For the database side of this, see the FDA registration and listing database guide.

Does a distributor have to register? Short answer by role

FDA’s “Who Must Register, List and Pay the Fee” page sorts establishments by activity. The rows below matter most to a distribution business, with the regulatory citation FDA gives:

Activity	Register	List	Pay fee	Citation shown
Wholesale distributor that is not a manufacturer or importer	No	No	No	807.20(c)
Domestic distributor that does not import devices	No	No	No	807.20(c)(3)
Initial importer	Yes	No (identifies manufacturers instead)	Yes	807.40(a); 807.20(a)(5)
Relabeler or repackager	Yes	Yes	Yes	807.20(a)(3)
Specification developer	Yes	Yes	Yes	807.20(a)(1)
Import agent, broker or other party that does not take first possession of an imported device	No	No	No	not stated
Refurbisher or remarketer of used devices already in U.S. commercial distribution	No	No	No	not stated

Source: FDA, Who Must Register, List and Pay the Fee, read 2026-11-07.

Who must register under 21 CFR 807.20

Section 807.20(a) requires registration and listing from those who manufacture or process devices. The paragraphs that catch distribution businesses are (a)(1), whoever initiates or develops specifications for a device manufactured by a second party; (a)(3), whoever repackages or relabels a device; and (a)(5), the initial importer. Section 807.20(d) separately sends distributors of human cells, tissues and cellular and tissue-based products (HCT/Ps) to FDA’s biologics center, using Form FDA 3356, rather than to this part.

The wholesale distributor exemption

Under 807.20(c), registration and listing do not apply to a wholesale distributor that does not manufacture, repackage, process or relabel a device. Section 807.3(t) defines a wholesale distributor as a person, other than the manufacturer or the initial importer, who distributes a device from the original place of manufacture to the person who makes the final delivery. Both halves matter: the definition excludes the initial importer, and the exemption ends once the business repackages, processes or relabels.

Relabeling versus adding your name

FDA defines a relabeler as an establishment that changes the content of the labeling supplied by the original manufacturer for distribution under its own name, and states that a relabeler does not include establishments that do not change the original labeling but merely add their own name. A repackager packages finished devices from bulk, or repackages a manufacturer’s devices into different containers, excluding shipping containers.

Initial importer duties

Section 807.3(g) defines an initial importer as an importer who furthers the marketing of a device from a foreign manufacturer to the person making final delivery or sale, without repackaging or changing the container, wrapper or labeling. FDA’s page adds that the initial importer must have a physical U.S. address staffed by individuals responsible for ensuring the compliance of imported devices with applicable FDA laws. An initial importer registers and pays the fee. For listing, 807.20(a)(5) lets it meet the duty for a device it did not develop, repackage or relabel by submitting the manufacturer’s name and address, and it must supply proprietary and common names when FDA requests them. Compare the role with importer of record in initial importer vs importer of record.

Exemptions in 21 CFR 807.65

Section 807.65 lists persons exempt from registration and listing. Those most relevant to supply businesses:

(a) manufacturers of components that are not finished devices, as described in the regulation;
(c) manufacturers of general-purpose articles such as chemical reagents or laboratory equipment;
(e) pharmacies, surgical supply outlets and similar retail establishments making final delivery or sale to the ultimate user; the exemption also applies to a pharmacy or similar retail establishment that purchases a device for subsequent distribution under its own name;
(f) manufacturers of devices intended solely for research and not in commercial distribution;
(h) carriers;
(i) persons who dispense devices to the ultimate consumer.

Exemptions (d), (e), (f) and (i) apply only to persons located in any State. For how buyers read the registered/unregistered distinction, see FDA-registered establishment.

Registration and listing steps for an establishment that must register

Classify the activity. Match what the site actually does to the FDA chart above, not to its trade name.
Pay the annual fee first. FDA’s page states that all establishments required to register must pay the user fee before completing registration, through the DFUF site, which issues a Payment Identification Number and Payment Confirmation Number.
Register and list electronically in FURLS, unless FDA has granted a waiver from electronic submission. For a device that needs a premarket submission, FDA asks for the submission number (510(k), De Novo, PMA, PDP or HDE).
Time the first registration. Initial registration and listing information is due within 30 days of beginning an activity or putting a device into commercial distribution; domestic importers must register before importing. If a device needs premarket clearance or approval, FDA says to wait for it before registering the establishment and listing the device.
Appoint a U.S. agent if the establishment is foreign. See the FDA U.S. agent guide.

Annual renewal and fee

Registration information must be submitted each year between October 1 and December 31, even if nothing has changed, and listing information must be reviewed in the same window. Registration follows FDA’s fiscal year (October 1 to September 30), and FDA treats a registration as active through the end of each calendar year. Listing updates can be made in FURLS at any time. The fee amount is set by FDA each fiscal year and published on its MDUFA fees page. FDA’s registration page says it may waive the annual fee, not the initial registration, for certain small businesses certified through the Small Business Determination Program, and refers readers to the MDUFA fees page for the current amount and criteria.

Common mistakes

Assuming the wholesale-distributor exemption covers an initial importer. Section 807.3(t) excludes the initial importer from the definition.
Treating a private-label arrangement as exempt. A business that develops specifications for a device made by a second party falls under 807.20(a)(1); one that changes the manufacturer’s labeling for distribution under its own name is a relabeler under 807.20(a)(3).
Assuming an initial importer lists like a manufacturer. Its listing duty under 807.20(a)(5) is met by identifying the manufacturer, but it still pays the registration fee.
Registering before a required premarket clearance, contrary to FDA’s timing note.

Page	What it covers
FDA registration and listing database	Searching the public database and what its fields show
FDA-registered establishment	What the term means to a buyer
Initial importer vs importer of record	Two roles often confused
FDA U.S. agent	Foreign establishment requirement

FAQ

What is FDA establishment registration?

It is the annual registration of establishments involved in producing and distributing medical devices for the U.S. market under 21 CFR Part 807, submitted electronically to FDA.

What is device listing?

Listing identifies the devices made at a registered establishment and the activities performed on them. FDA’s page says most establishments required to register must also list.

What is 21 CFR 807?

21 CFR Part 807 is the FDA regulation on establishment registration and device listing. Section 807.20 says who must register, 807.3 gives the definitions, and 807.65 lists exemptions.

Is there an FDA establishment registration fee, and how much is it?

Yes, for establishments FDA’s chart marks as paying the fee. The amount changes with each fiscal year; the current figure is on FDA’s MDUFA fees page, and the fee must be paid before registration is completed.

What are FURLS and DFUF?

FURLS is FDA’s electronic system for registration and listing; the Device Facility User Fee (DFUF) site is where the annual fee is paid and the payment numbers are issued.