FDA Medical Device Establishment Registration & Listing
FDA establishment registration and device listing through FURLS, for device makers selling in the US.
- Signed by a qualified safety assessor
- Regulator-ready, or we revise it free
- Delivered in 24, 48 or 72 hours
Trusted by brands including
Service details
Everything included, explained
Quick answer
Medical device establishments selling in the US must register with FDA every year and list their devices. We prepare and submit registration and listing through FDA's FURLS system after you pay FDA's annual registration fee, which is $13,785 for FY2027 and is extra. Testing and labs are excluded. £445 for registration and one device; £90 per extra device.
What's included in your registration and listing
| Document | What it is |
|---|---|
| Fee guidance | How to pay the FDA annual registration fee and get your PIN and PCN |
| Establishment registration | Submitted in FURLS |
| Device listing | Product code and device details listed |
| US agent check | Confirms the US agent for a foreign establishment |
| Renewal date | Annual renewal between 1 October and 31 December |
Who this service is for
- Makers of menstrual cups, pads and other exempt devices
- Foreign manufacturers exporting devices to the US
- Brands with a cleared 510(k) needing registration
What this service does not include
- FDA fees. FDA's annual device establishment registration fee ($13,785 for FY2027, 1 Oct 2026 to 30 Sep 2027) is extra and paid by you.
- Testing. Laboratory testing, lab fees and test reports are not included.
- A 510(k). Needed separately for devices that are not exempt.
- A US agent. Available as a separate service.
- FDA approval. Registration and listing are not FDA approval or clearance.
How it works
- Pay the FDA fee We guide you through paying the annual fee.
- Send your details Establishment, devices, product codes and US agent.
- Submit We register and list in FURLS.
- Confirmed We send your registration and listing numbers. FDA processing time varies and is outside our control, so we do not guarantee a date.
What is device establishment registration and listing?
Under FD&C Act section 510 and 21 CFR Part 807, establishments involved in making or distributing medical devices for the US must register annually with FDA and list their devices, through the FURLS system. Registration requires payment of the annual establishment registration fee first. Foreign establishments must name a US agent. Registration and listing do not mean FDA has approved or cleared a device.
Fees and timing
FDA fee:
- FY2027 annual registration: $13,785, paid by you, no small business reduction.
Timing:
- Annual renewal: 1 October to 31 December.
- New devices: Listed before commercial distribution.
What you receive
- Establishment registration number
- Device listing numbers
- Renewal reminder
Legal framework
- FD&C Act section 510 — registration and listing
- 21 CFR Part 807 Subpart B — registration and listing procedures
- 21 CFR 807.40 — foreign establishments and US agent
- FD&C Act section 738 — establishment registration fee
Official sources:
Why brands choose Phoenix
- Clear about the FDA fee before you start.
- Extra devices at a low per-device price.
- Reviewed by Syed Muhammad Shamuel Shees, US Regulatory Lead.
Register and list before you ship. Order above, or message us on WhatsApp on +44 7346 009332.
Frequently asked questions
Is the FDA registration fee included?
No. FDA's annual device establishment registration fee ($13,785 for FY2027, 1 Oct 2026 to 30 Sep 2027) is extra and paid by you.
How often is device registration renewed?
Every year, between 1 October and 31 December.
Do 510(k)-exempt devices need registration?
Yes. Exempt devices such as menstrual cups still need establishment registration and listing.
Is testing included?
No. Laboratory testing, lab fees and test reports are not included.
Does registration mean FDA approval?
No. Registration and listing are not FDA approval or clearance.
How much does the service cost?
£445 for registration and one device, plus £90 for each extra device.