FDA Registration for 510(k)-Exempt Devices
How an exempt device actually registers and lists — the steps, the fee that still applies, and what the listing shows.
Key Takeaways
- Exempt from 510(k) ≠ exempt from registration — you still register & list (21 CFR Part 807).
- The annual establishment fee still applies — FY2026 $11,423 (a government fee).
- DUNS + FURLS/DRLM — same systems as any device establishment.
- List under the exempt product code — no 510(k)/K-number to cite.
- General controls + full quality system if sterile — labeling, MDR, records/complaints.
- Renew annually Oct 1–Dec 31; exempt ≠ cleared ≠ approved.
Registering an Exempt Device
- Confirm the exemption. Verify the product code is 510(k)-exempt, isn't "reserved," and that your device fits the generic type (no new use or different technology per the xxx.9 limits). See the 510(k) exemption guide.
- Get a DUNS number. FDA verifies the establishment via Dun & Bradstreet — keep name/address consistent.
- Pay the annual establishment fee. The MDUFA fee applies to every registered establishment (FY2026 $11,423), via the DFUF system — even for exempt devices.
- Register the establishment. In FURLS/DRLM under 21 CFR Part 807, role-specific.
- List the device. Under its exempt product code — no 510(k)/K-number, since there was no premarket submission.
- Maintain general controls. Labeling/UDI, MDR, records & complaint files — and the full quality system if the device is sterile. Renew annually (Oct 1–Dec 31).
Exempt From 510(k) ≠ Exempt From the Fee
This is the point companies most often get wrong: the exemption from 510(k) does not waive the annual establishment registration fee. Every registered device establishment owes the MDUFA annual fee, whether or not its devices are exempt.
- FY2026: $11,423 per establishment (FY2027: $13,785) — a flat government fee paid to FDA
- No proration — the same fee regardless of when in the year you register
- Per establishment, not per device — one fee covers the facility and all the devices you list
- Possible waiver (new for FY2026) — certain SBD-certified small businesses may qualify
What an Exempt Device's Listing Shows
- The device and its product code — listed like any device
- No 510(k) (K-number) or PMA number — because there was no premarket submission
- The activities you perform — manufacture, spec developer, repacker, etc.
- Reviewed/updated annually — during the Oct 1–Dec 31 window
Common Mistakes Registering Exempt Devices
- Assuming exempt means no registration — it doesn't
- Not budgeting for the annual establishment fee — it still applies
- Treating a sterile device as fully GMP-exempt — sterile = full quality system
- Listing incompletely or under the wrong product code; skipping UDI
- Calling the device "FDA approved/cleared"; missing the annual renewal
- Missing the U.S. Agent (foreign manufacturers)
Exemption, Classification & Registration
Register Your 510(k)-Exempt Device
FDA Registration Assistance confirms the device is genuinely 510(k)-exempt (product code, xxx.9 limits, reserved status, sterility), obtains a DUNS number, coordinates the MDUFA establishment fee, completes establishment registration and device listing in FURLS/DRLM under the exempt product code, reviews labeling/UDI and general controls, and provides U.S. Agent service for foreign makers.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333 for a quote. An independent compliance firm serving 1,000+ companies across 135+ countries, with 15+ years of experience.
Frequently Asked Questions — Registering Exempt Devices
1. Do 510(k)-exempt devices need to register with FDA?
Yes. Being exempt from 510(k) only removes the premarket notification - it does not remove establishment registration and device listing. A 510(k)-exempt device still requires FDA establishment registration and device listing under 21 CFR Part 807 (via FURLS/DRLM), plus compliance with general controls. So an exempt device is registered and listed, just without a 510(k) submission. "Exempt from 510(k)" is not "exempt from registration."
2. Do exempt devices still owe the annual FDA establishment fee?
Yes - this surprises a lot of companies. The exemption from 510(k) does not waive the annual establishment registration fee. Every registered device establishment owes the MDUFA annual fee - $11,423 for FY2026 (and $13,785 for FY2027) - regardless of whether its devices are 510(k)-exempt. It's a flat government fee paid to FDA. (A new-for-FY2026 waiver may apply to certain SBD-certified small businesses.) So budget for the annual fee even if you never file a 510(k).
3. How do I register a 510(k)-exempt device, step by step?
Confirm the device is genuinely exempt (product code, xxx.9 limits, not "reserved," sterility); obtain a DUNS number; pay the annual establishment fee through the DFUF system; register the establishment in FURLS/DRLM (21 CFR Part 807); list the device under its exempt product code; and maintain general controls (labeling, MDR, records, complaint files) plus the full quality system if the device is sterile. Foreign establishments also appoint a U.S. Agent. The only thing you skip versus a non-exempt device is the 510(k) itself.
4. How is listing different for an exempt device?
You list the device under its classification/product code just like any device, but the listing reflects that the device is 510(k)-exempt - there's no 510(k) (K-number) or PMA number to cite, because the device had no premarket submission. The listing shows the device, its product code, and the activities you perform. Listing an exempt device is still required and is reviewed/updated annually (October-December) like other listings.
5. What general controls apply to an exempt device?
All of them except premarket notification: compliant labeling (21 CFR Part 801) and UDI where applicable (21 CFR Part 830); Medical Device Reporting (21 CFR Part 803); records (21 CFR 820.180) and complaint files (21 CFR 820.198), which apply even under the Class I GMP exemption; reporting of corrections/removals; and the prohibitions against misbranding and adulteration. An exempt device is a marketed device, so the marketed-device obligations apply.
6. Does a sterile exempt device need the full quality system?
Yes. Most Class I devices are exempt from most of the quality system regulation except records and complaint files - but that GMP exemption does not apply to devices labeled or represented as sterile. So a sterile 510(k)-exempt device must comply with the full quality system (now the QMSR), including sterilization validation - even though no 510(k) is required. The exemption is from premarket notification, not from making a sterile product properly.
7. How do I confirm my device is really exempt before registering?
Check the product code in FDA's Product Classification Database (the 510(k)-exempt and GMP-exempt indicators), read the classification regulation and its xxx.9 limitations, and confirm the device fits the generic type (same intended use and fundamental technology) and isn't "reserved." A new intended use or different technology can remove the exemption and require a 510(k). Confirm the exemption before you register and list, so you don't market a device that actually needed a 510(k).
8. Is a registered exempt device "FDA approved" or "cleared"?
No. An exempt device receives no FDA premarket review, so it's neither "cleared" (a 510(k) term) nor "approved" (a PMA term) - it's simply registered and listed. There's no clearance or approval number to cite. Marketing it as "FDA approved," "FDA cleared," or even implying registration equals approval is misleading (see 21 CFR 807.39). The accurate statement is that your establishment is registered and the device is listed.
9. When do I register and renew an exempt device?
Initial registration is generally required within 30 days of beginning covered operations, and registration renews annually between October 1 and December 31 along with payment of the annual establishment fee and a review of your listings. This is the same timing as any device establishment - the exemption doesn't change the registration/renewal cycle or the fee deadline. Missing the annual window can leave you not duly registered.
10. Do foreign makers of exempt devices need to register (and a U.S. Agent)?
Yes. A foreign manufacturer of a 510(k)-exempt device must complete establishment registration and device listing, pay the annual fee, comply with general controls (and the full quality system if sterile), and appoint a U.S. Agent - just without a 510(k). The exemption doesn't remove the foreign-establishment registration, fee, or U.S. Agent requirements. Imported exempt devices are checked for proper registration and labeling at entry.
11. Is registering an exempt device cheaper than a non-exempt one?
You save the 510(k) submission (and its FDA submission fee and preparation effort), which is significant. But the annual establishment registration fee is the same, and you still do registration, listing, labeling, quality (records/complaints, or full system if sterile), and MDR. So an exempt device is less work up front (no 510(k)) but not free - the ongoing registration obligations and the annual fee are identical to a non-exempt device.
12. What if my "exempt" device actually needs a 510(k)?
Then registering and listing it as exempt doesn't make it legal - the device would be adulterated/misbranded and not lawfully marketed until you obtain the required 510(k). This happens when a device is "reserved," has a new intended use, or uses a different fundamental technology (the xxx.9 limits). That's why confirming the exemption comes before registration. If a 510(k) turns out to be required, the pathway is the standard premarket-notification process.
13. Can you register several exempt devices under one establishment?
Yes. One establishment registration covers the facility (with one annual fee), and you list each device you make under its own product code within that registration. So a company with several exempt devices registers the establishment once and lists each device. Each listing is kept current, and the single annual establishment fee covers the establishment - the fee is per establishment, not per device.
14. Does an exempt device need UDI?
Being 510(k)-exempt doesn't remove UDI. Unique Device Identification (21 CFR Part 830) applies based on the device's class and type and the applicable compliance dates, not on whether it's exempt from 510(k). Many devices need a UDI on the label and GUDID data submission. So factor UDI into your labeling for an exempt device where it applies - the exemption is only from premarket notification.
15. What are the most common mistakes registering exempt devices?
Assuming exempt means no registration (it doesn't); not budgeting for the annual establishment fee (it still applies); treating a sterile device as fully GMP-exempt; listing incompletely or under the wrong product code; skipping UDI; calling the device "FDA approved/cleared"; missing the annual renewal; and (for foreign makers) missing the U.S. Agent. Most trace back to over-reading "exempt" - it removes the 510(k), not the rest of the obligations.
16. How does FDA Registration Assistance help register exempt devices?
We confirm the device is genuinely 510(k)-exempt (product code, xxx.9 limits, reserved status, sterility), obtain a DUNS number, coordinate the MDUFA establishment fee, complete establishment registration and device listing in FURLS/DRLM under the exempt product code, review labeling/UDI and general controls, and provide U.S. Agent service for foreign makers - so your exempt device is properly registered and listed without over- or under-doing it. We're an independent compliance firm serving 1,000+ companies across 135+ countries with 15+ years of experience. Contact info@fdaregistrationassistance.com or +1 (928) 275-8333.
