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513(g) check

A 513(g) asks FDA how it classifies a product and what rules apply. It costs a user fee and takes about 60 days, so it pays to know when it's the right tool.

What do you need FDA to answer?

Whether my product is a medical device at all How my device is classified (class, product code, regulation) Which regulatory requirements apply to it What testing or data FDA expects

Do you already know the product code and regulation?

Yes No Not sure

See the answer

A screening aid, not a determination. The answer follows FDA's published guidance and cites it, but only FDA decides, through a Pre-Sub, a 513(g) or the submission itself. Confirm with FDA or a qualified regulatory professional. Fees and review goals are planning figures. Nothing you answer is saved.

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513(g) requests in plain terms and Pre-Subs in plain terms.

Other free tools: Special 510(k) · De Novo · 513(g) · Breakthrough · classification lookup · predicate search · Learn