Third-party status is not the whole story

MedTech Founder Tip:

Let’s talk about FDA accredited third party reviewers because this designation is often misunderstood.

Third party accreditation can absolutely be valuable. But founders should understand exactly what the designation covers.

Under FDA’s 510(k) Third Party Review Program, also referred to as the 3P510k program, recognition is tied to the device types and product codes an organization is authorized to review. It is not automatically a blanket authorization to review every 510(k).

You’ll often see FDA accredited third party reviewer highlighted prominently in marketing, while the specific product codes covered by that accreditation may be much less obvious.

That distinction matters.

And you can verify it yourself directly through FDA.

FDA maintains a public list of devices eligible for third party review, as well as a list of recognized Third Party Review Organizations showing the product codes they are authorized to review. You can look up your product code and confirm whether it falls within a particular organization’s FDA recognized review scope.

And remember, the third party organization conducts the primary review and makes a recommendation. FDA still makes the final 510(k) determination.

Third party status can be meaningful.

But the real question is not simply:

“Are you FDA accredited?”

It’s:

“Are you FDA accredited for my product code?”