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513(g) requests in plain terms

Draft, not yet reviewed by a regulatory professional. Written from FDA's published guidance, which is cited below; read the guidance itself before you rely on any of it.

Section 513(g) of the FD&C Act lets anyone ask FDA, in writing, how it classifies a product and what requirements apply. It is the formal answer to "is this a device, and which kind?"

What it's for

Whether a product is a medical device at all.
Its likely class, product code and regulation, when the classification database doesn't make that clear.
Which regulatory requirements FDA believes apply.

What it isn't

FDA's answer is not a classification decision, and FDA does not review data on safety, effectiveness or substantial equivalence in a 513(g). For questions about your testing plan or your predicate, a Pre-Sub is the tool, and it has no user fee.

Time and cost

FDA aims to respond within 60 days. The FY2027 user fee is $8,596, or $4,298 with small-business status. Since 2024 a 513(g) can be sent through eSTAR, voluntarily.

Before paying, try the free classification lookup; then the 513(g) check.

Sources

General information, not regulatory advice. FDA decides every classification and submission; confirm your route with FDA (a Pre-Sub or a 513(g)) or a qualified regulatory professional. Fees and review goals are planning figures; check FDA's current schedule.

More: Choosing an FDA pathway · Traditional, Special or Abbreviated 510(k) · De Novo in plain terms · Pre-Subs (Q-Submissions) in plain terms · The Breakthrough Devices Program