FDA Device Establishment Registration and Listing Program

FDA device establishment registration identifies covered establishments, while device listing identifies their devices in commercial distribution under 21 CFR Part 807 Subpart B. This service supports non-exempt manufacturers, initial importers and specification developers with registration, listing and annual confirmation. Integral Healthcare Solutions (IHS) drafts the checklist, calendar and owner map; the client files electronically unless an applicable FDA exception permits another method.

Last updated: November 2026

What is FDA device establishment registration and listing?

Under 21 CFR 807.20, non-exempt owners or operators engaged in manufacturing, preparing, propagating, compounding, assembling or processing human-use devices register and list devices in commercial distribution. For HCT/Ps regulated under the Federal Food, Drug, and Cosmetic Act, paragraph (d) instead requires registration and listing on Form FDA 3356 under Part 1271 Subpart B; section 807.26 additional listing requirements still apply. Paragraph (e) directs manufacturers of devices licensed under Public Health Service Act section 351, and licensed biological products used to manufacture a licensed device, to Part 607 procedures.

The text is 21 CFR Part 807 Subpart B in the current eCFR Title 21; Title 21 as a whole was last amended September 8, 2026, a title-wide date, not a Part 807 change date. We read sections 807.3, 807.20, 807.21, 807.22, 807.25, 807.26 and 807.28 in the official eCFR text from the Government Publishing Office on November 5, 2026. The exemptions in section 510(g) and subpart D are outside this page, so your counsel or regulatory staff decide whether one applies. Section 807.20(c) excludes a wholesale distributor, as defined in section 807.3(t), that does not manufacture, repackage, process or relabel a device.

Initial registration and listing are due within 30 days after an owner or operator first enters a covered operation. Annual registration, listing review and confirmation occur October 1 to December 31. Changes to registration information described in section 807.25(b) are due within 30 days; listing changes follow separate rules. The table's suggested work products are IHS's recommendations as of November 5, 2026.

Who needs it and what triggers it?

These triggers apply to non-exempt owners or operators covered by section 807.20(a).

• An owner or operator first enters a covered operation: register and list within 30 days under section 807.22(a).
• A company develops specifications for another party to manufacture: section 807.20(a)(1) includes this activity.
• Registration information described in section 807.25(b) changes: update it within 30 days.
• A foreign establishment's device is imported or offered for import: its listing must already have been submitted under section 807.28(c).

How IHS helps

IHS assesses gaps against sections 807.20 to 807.28, maps records to requirements and drafts missing program materials for your regulatory staff to approve. A mock review checks the packet, followed by readiness support before the client files. The drafts are a registration and listing checklist, an annual update calendar with the October 1 to December 31 window, a responsible-owner map, a device and establishment data sheet and a change-trigger log. IHS was founded in 2002 by Thomas G. Goddard, JD, PhD, former Chief Operating Officer and General Counsel of URAC, and works across three practice lines: accreditation consulting, compliance services and program development. This build sits in our Compliance Services line.

Your company supplies establishment details, owner or operator information and device records, including product codes or FDA premarket submission numbers as applicable under section 807.25(g). Your company files in FDA's electronic system, your designated official correspondent serves as FDA's point of contact, and your counsel answers exemption questions.

The limit: IHS does not register or file with FDA, communicate with FDA for you, or decide exemptions or classification.

What to have ready

The checklist follows current 21 CFR Part 807, opened November 5, 2026.

1. Each establishment's activities and applicability determination (21 CFR 807.20).
2. Establishment and owner or operator details and the designated official correspondent (21 CFR 807.25(b), (e)).
3. The date the owner or operator first entered a covered operation (21 CFR 807.22(a)).
4. Device names, establishment activities, product codes where section 807.25(g)(2) applies, and FDA premarket submission numbers where paragraph (g)(4) applies (21 CFR 807.25).
5. The client's filing method, including any granted electronic-filing waiver (21 CFR 807.21).
6. The October 1 to December 31 annual registration, listing review and confirmation window (21 CFR 807.22(b)).
7. Changes to registration information described in section 807.25(b), with 30-day deadlines (21 CFR 807.22(b)(2)).
8. Foreign-establishment listing dates before devices are imported or offered for import (21 CFR 807.28(c)).

Bring these records to a free introductory call to discuss the scope of IHS's drafting support.

How does outside drafting support compare with other routes?

Options include an internal build, outside regulatory-affairs advice, or IHS drafting support. An internal build uses your staff to interpret requirements and maintain records. IHS drafts the checklist, calendar and owner map; your company retains filing responsibility. The governing requirements come from 21 CFR Part 807. For the alternative HCT/P registration route in section 807.20(d), see the HCT/P establishment page; section 807.26 additional listing requirements still apply.

What does it cost?

FDA's FY 2027 fee schedule lists an annual establishment registration fee of USD 13,785 for October 1, 2026 to September 30, 2027 (page opened November 5, 2026). Most establishments must pay it. FDA may waive the annual fee, excluding initial registration, for certain small businesses qualified through its Small Business Determination program that demonstrate financial hardship as determined by FDA. Verify current fees with FDA. IHS scopes each engagement after a free introductory call. Scope depends on establishment count, device lines and the condition of your records.

What this is not

This is not legal advice. IHS is a consulting firm, not a law firm, and your regulatory counsel decides exemptions and classification. It is not a guarantee that FDA accepts a submission.

Frequently asked questions

Who must register as a device establishment under 21 CFR 807?

An owner or operator of an establishment not exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act or subpart D, who is engaged in the manufacture, preparation, propagation, compounding, assembly or processing of a device intended for human use, must register and submit listing information for those devices in commercial distribution. A parent, subsidiary or affiliate may submit for all domestic or foreign establishments it controls when operations occur at multiple establishments and all share joint ownership and control. A wholesale distributor as defined in section 807.3(t), a term that excludes the manufacturer and the initial importer, is outside these requirements if it does not manufacture, repackage, process or relabel a device. Your counsel decides whether an exemption applies.

Does a specification developer who uses a contract manufacturer have to register?

Section 807.20(a)(1) includes developing specifications for a device another party will manufacture. For a non-exempt establishment, the owner or operator must register and list devices in commercial distribution; your counsel confirms applicability to your facts.

When must a new device company register and list its products, and how is it filed?

An owner or operator who has not previously entered into an operation described in section 807.20(a) registers within 30 days after entering into it and submits device listing information at that time (section 807.22(a)). Your responsible person files electronically unless FDA grants a waiver because electronic means are not reasonable for the requester; requested additional listing information under section 807.26(e) goes by postal mail or email, outside that system.

When is the annual registration and listing update due?

Annual registration takes place from October 1 to December 31 of each fiscal year (section 807.22(b)(1)). During that period owners or operators review all listings, report changes, deletions and previously unreported new listings, and confirm all information's accuracy even if the device list did not change (section 807.22(b)(3)).

What changes must be reported, and how fast?

Changes to registration information described in section 807.25(b) must be reported within 30 days; listing changes may also be made outside the annual review window under section 807.22(b)(4). Under section 807.28(d), an owner or operator discontinuing commercial distribution must discontinue the listing electronically; a listing is considered discontinued when all devices under its exempt product code or FDA premarket submission number have been discontinued. Under section 807.28(e), resuming distribution requires electronic reactivation of that listing and updating changed listing information at reactivation. IHS records the applicable action and timing for each change.

Does an initial importer have to list devices?

Yes, for a non-exempt establishment. Section 807.20(a)(5) covers a person who acts as an initial importer as defined in section 807.3(g). An initial importer may fulfill its listing obligation for a device it did not specify, repackage or relabel by submitting the name and address of the manufacturer, and must be prepared to submit the proprietary name, if any, and the common or usual name of each device when FDA requests. Your counsel confirms how that applies to your company.

What happens if an establishment misses a required step?

Failure to submit required information on time will put the establishment in a failed to register or failed to list status as applicable (section 807.22(c)). The establishment will not be considered active, and its information may not appear on the FDA Web site until the owner or operator submits and FDA processes the required information.

When must a foreign establishment submit device listings?

Under section 807.28(c), all device listings for foreign establishments must be submitted before the device may be imported or offered for import into the United States. IHS drafts a pre-import listing check for the importer.

What does a registration and listing program build cost?

FDA lists an annual establishment registration fee of USD 13,785 for FY 2027; see the fee section above for applicability and waiver limits. Verify current fees with FDA. IHS scopes each engagement after a free introductory call, based on establishment count, device lines and record completeness.