What is a 513(g) request?

In short: A 513(g) is a formal, fee-based request asking FDA how it would classify your product and which regulatory requirements apply. It is useful when device status is genuinely unclear, but slower and less interactive than a Pre-Submission — many teams get more value from a Q-Sub.

What a 513(g) actually delivers

A 513(g) request, named for the FD&C Act section that establishes it, asks FDA directly: what is this product's classification, and what regulatory requirements would apply to it. FDA responds in writing, typically within 60 days, with its view on your product's classification and the requirements that would apply. Unlike a Pre-Submission, a 513(g) is a one-way, fee-based request rather than an interactive meeting — you submit a description of your product and get a written answer back, without the back-and-forth discussion a Pre-Sub allows.

When it's the right tool

A 513(g) is most useful when the core question is genuinely "is this a device, and if so what class" — for products sitting close to the wellness/device boundary, or where classification itself, not pathway or predicate strategy, is the open question. It gives you something a Pre-Sub can't: a formal written statement from FDA on classification status specifically, which can matter for investor due diligence or partnership conversations where "we believe" isn't as strong as "FDA has said in writing." One caveat to carry into those conversations: a 513(g) response is FDA's advisory opinion, not a binding classification decision — the agency can revise its position as facts change — so present it as FDA's documented view, not a permanent ruling.

Why many teams reach for a Q-Sub instead

For most practical purposes — predicate strategy, testing plan feedback, pathway confirmation — a Pre-Submission meeting is faster, free, and interactive, letting you ask follow-up questions in real time rather than waiting for a single written response. The 513(g) is worth its slower, fee-based process specifically when a formal, standalone written answer on classification is the actual deliverable you need, not just internal confidence about where you likely sit.

Where next: 510(k) vs De Novo vs PMA: Which FDA Pathway · What is an FDA Pre-Submission (Q-Sub), and should I do one?

Find out in minutes where your product likely sits. Start the MedTech Compass → — AI-generated first read, not a validated determination.