Two lists decide who reviews your 510(k)

A granted 510(k) can carry a flag saying an accredited third party, not FDA staff, reviewed it first — a fact worth reading carefully on its own. But that flag is the end of a process, recorded after the fact on a record already public. The question that matters before a sponsor ever files is upstream of that flag entirely, and it is decided by two lists FDA maintains separately, neither of which is a field on any 510(k) record at all.

The first list says which devices may even ask

Section 523 of the FD&C Act (21 U.S.C. § 360m) directs FDA to accredit persons in the private sector to conduct the primary review of certain premarket notifications. “Certain” is doing real work in that sentence: eligibility is not a blanket rule for low-to-moderate-risk devices, and it is not derived from device class the way a 510(k) exemption is. FDA publishes a standing List of Devices for Third Party Review, organized by classification regulation under 21 CFR Parts 862 through 892 and grouped by clinical panel, with the specific product codes eligible under each regulation listed beneath it. A product code’s absence from that list is dispositive: the device cannot go this route, whatever its class.

The second list says who is standing in that door

Appearing on the eligibility list answers only whether the pathway exists for a device type. It does not answer whether anyone can currently walk a sponsor’s submission through it. FDA maintains a separate List of FDA-Recognized 510(k) Third Party Review Organizations — the firms it has accredited to do this work — and accreditation itself is scoped: a recognized organization is authorized for particular device types, not the eligibility list in its entirety. FDA finalized updated guidance on the whole program, folding in third-party review of emergency use authorizations, in November 2024, superseding the guidance the program had run under for more than two decades.

Eligible answers whether the door exists. Accredited, for this device, answers whether anyone is standing in it.

Not in the corpus this pipeline reads

FDA Radar reads the openFDA 510(k) endpoint daily — K-number, applicant, product code, decision, and the third-party-review flag a clearance already carries. It does not read either list described above; both live only as standalone accessdata.fda.gov pages, the same shape of gap as the Recognized Consensus Standards list. See what we monitor and how often for the rest of that boundary.

The practice

Before treating third-party review as a filing strategy, confirm both lists independently and on their own current pages — the product code against the eligibility list, then the device type against the accreditation list — rather than checking the first and assuming the second follows. And a favorable third-party review still ends the same way every 510(k) does: FDA, not the reviewing organization, signs the clearance. Whether this pathway fits a specific device is a determination for a regulatory professional working the file; this describes how the two lists are structured, never a recommendation to use either.