Third Party Review
Third Party Review lets an FDA-accredited organization conduct the review of an eligible 510(k) and make a recommendation to FDA. FDA then makes the decision. The program is authorized under section 523 of the FD&C Act. FDA states that approximately half of the 510(k)s it receives are eligible.
FD&C Act 523; FDA 3P510k Review Program guidance, 20 November 2024
At a glance
| Who reviews | An FDA-accredited Review Organization. FDA makes the final decision. |
|---|---|
| FDA user fee | None. FDA charges no user fee for a 510(k) submitted on behalf of an accredited third party. |
| What you pay instead | A fee set by agreement between you and the Review Organization, paid directly to it. |
| FDA decision deadline | Within 30 calendar days of receiving the Review Organization's recommendation. |
| Eligibility | Around half of 510(k)s. Class III devices are excluded by statute. |
| Also excluded | De Novo-classified devices, Breakthrough-designated devices, and devices intended to be permanently implantable, life-sustaining or life-supporting unless FDA lists them as eligible. |
| One more exclusion | If you previously submitted a 510(k) for that device that ended in anything other than an SE decision, that device is no longer eligible for this route for you. |
| Where to check | FDA publishes both the list of accredited Review Organizations and the list of eligible device types. |
How device types get on the list
Eligibility is set by device type, not by individual device. FDA publishes the factors it applies.
- The risk of the device type. Class III devices are excluded by statute.
- Whether the device is intended to be permanently implanted, or to sustain or support life.
- How well understood the device type is. Devices with novel technological characteristics, including some requiring complex special controls initially classified through De Novo, may be ineligible.
- Whether the information needed to make a well-informed recommendation can be shared outside FDA.
- Whether review of the type requires multifaceted, interdisciplinary expertise.
- Whether postmarket data suggests the device type is the subject of a safety signal.
FDA gives its own worked example of the last factor: duodenoscopes carry a safety signal associated with their reprocessing, and FDA removed duodenoscopes and their accessories from eligibility.
Questions people ask
Is it cheaper overall?
There is no FDA user fee, which removes $28,653 from 1 October 2026, or $7,163 for a qualified small business. The Review Organization's own fee replaces it and is set by agreement. Whether the total is lower depends on that agreement, and a small business may find the standard route cheaper.
How do we know if our device is eligible?
FDA publishes a searchable list of device types eligible for third party review, and the FDA Product Classification Database shows third party eligibility as a field on each product code record.
Does the third party clear our device?
No. The Review Organization conducts the review and makes a recommendation. FDA makes the determination and issues the decision.
Can we choose any accredited organization?
You choose from those accredited for your device type. FDA's published list shows which device types each organization is accredited to review, along with contact details.
We filed a 510(k) before and withdrew it. Can we use this route now?
No. FDA states that if a submitter previously submitted a 510(k) for a device that resulted in anything other than an SE decision, that device is not eligible for the third party pathway for that submitter.