Regulatory Affairs
513(g) Request for Information / Device Classification
Get FDA’s view on your device’s classification and regulatory pathway.
What It Is
A 513(g) is a formal request asking FDA for its view on the classification and the resulting regulatory requirements for your device. It is the right tool when your device’s classification is genuinely ambiguous — a new intended use, a combination of features, or a software function whose regulatory status is unclear.
When You Need It
You need a 513(g) when you cannot confidently determine whether your device is Class I, II, or III, whether it is even a device, or which pathway (exempt, 510(k), De Novo, PMA) applies. Resolving classification early prevents building a strategy on a wrong assumption.
What We Do
We research the classification regulations, product codes, and precedent first, and often resolve the question without a 513(g). When the ambiguity is real, we prepare the 513(g) request with a clear device description and our classification rationale, and translate FDA’s response into the correct downstream strategy.
We Live It, Not Just Advise It
We have classified and brought our own and our clients’ devices to market across orthopedic, cardiovascular, IVD, and surgical categories. Classification is not an academic exercise for us — it is the first decision in a program we then have to actually execute end to end.
Frequently Asked Questions
How long does a 513(g) take?
FDA’s goal is to respond to a 513(g) within about 60 days. There is also a user fee, discounted for qualified small businesses. Often we can answer your classification question through research before recommending the formal request.
Is a 513(g) response binding?
A 513(g) gives you FDA’s view of classification based on the information you provide; it is informative rather than a binding determination, but it is strong, citable guidance for planning your pathway.
Ready to Talk Through Your 513(g) Project?
Tell us where you are in the process. We respond within one business day.
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