Flat-Fee · Classification & 513(g)
Classification is the first regulatory question for every medical device. Your FDA product code, device class, and regulation number determine your entire pathway — 510(k), De Novo, PMA, or exempt. Two flat-fee services get you there. Both are published. Both are honest about what they do and don't include.
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Choose the level of formality your situation requires. Both are flat-fee. Neither bills hourly.
Classification Determination Memo
flat fee · no FDA filing · no FDA user fee
FDA's own 513(g) user fee alone runs several times this memo — when you need the formal filing, start here first.
Formal 513(g) — Reviewed & Submitted
flat fee · includes element review + FDA submission
FDA's response, timing, and conclusions are FDA's alone — the review addresses what's within your control.
FDA's 513(g) user fee is set each fiscal year and paid separately, directly to FDA — a reduced small-business rate is available for FDA-certified small businesses. Never hardcoded here because it changes annually.
The gap gate — element creation is quoted after the review, never upcharged in advance. The included review assesses whether your device description, intended-use narrative, and labeling meet FDA's content expectations for a 513(g) and flags the risks if they don't. If required elements are missing or need to be written, we quote preparing them after the review — you will know the full cost before anything is filed.
Choosing the Right Service
Most companies need the answer, not the filing. If your goal is to identify your product code, confirm your device class, and understand your pathway before choosing between 510(k), De Novo, or PMA — the Classification Determination Memo gets you there in days, without an FDA user fee or a formal submission on your regulatory history.
A formal 513(g) makes sense when a development partner, investor, importer, or regulatory authority requires FDA's official written position. It is also the right choice when you are committing resources to a development program and need a durable regulatory anchor — one you can cite in due diligence, a Pre-Submission meeting, or a clearance application.
Sometimes the better path is a free FDA Pre-Submission (Q-Sub) meeting rather than a 513(g). A Pre-Sub is appropriate when you already have a good sense of classification and need FDA's feedback on specific questions about your submission approach. If that is the case — and it applies to your situation — we will say so during the element review. The assessment is honest regardless of which service it points toward.
What FDA Requires
FDA's 513(g) guidance specifies what must be in the request. The element review checks your package against these expectations before anything is filed.
Have all of these? You are base-price ready. Missing some? That is what the element review is for — we identify the gaps and quote filling them before anything is filed.
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Submit your details and we will confirm the right service and next steps within one business day.
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Common Questions
FDA product codes are three-character identifiers assigned to each device type in FDA's 21 CFR Parts 862–892 classification regulations. You can search the FDA Product Classification Database using your device's intended use or technology. ADB's Classification Determination Memo identifies the correct product code, device class, and applicable regulation for your specific device — delivered in writing.
Device class (I, II, or III) is determined by the risk level and the level of regulatory control needed to provide reasonable assurance of safety and effectiveness. Class I devices are subject to general controls; Class II to special controls (and usually 510(k)); Class III to PMA. The correct class for your device depends on its specific intended use, design characteristics, and predicate landscape — not just its category.
ADB's base fee for the Formal 513(g) — Reviewed & Submitted service is $2,995, covering the substantive element review, findings summary, submission assembly, and FDA correspondence through the 60-day statutory response. FDA's 513(g) user fee is set each fiscal year and paid separately, directly to FDA — a small-business reduced rate is available for eligible FDA-certified small businesses. The element review is completed before any FDA fee is paid.
FDA's target response time for a 513(g) request is 60 calendar days from the date FDA accepts the request. FDA may request additional information, which can extend the window. A straightforward classification question on a familiar device type typically receives a response within 60–90 days. The response describes FDA's current classification position and applicable regulatory requirements.
No. A 513(g) response is FDA's written opinion on classification and applicable requirements — it is not a clearance, an approval, or a classification order. It reflects FDA's current regulatory position and carries significant weight in submission strategy and investor due diligence, but it does not substitute for any required premarket submission (510(k), De Novo, or PMA).
If your goal is to identify your product code, class, and pathway quickly without a formal FDA filing, the Classification Determination Memo is the right starting point. If you need FDA's official written position — for investors, partners, or regulatory anchoring — the Formal 513(g) is appropriate. If you already know your pathway and have specific questions for FDA about your submission strategy, a Pre-Submission (Q-Sub) meeting may be more efficient. ADB will recommend the right approach during the element review.
Not Sure Where to Start?
A free strategy call takes 20 minutes. We will tell you exactly what your device needs — classification memo, 513(g), Pre-Sub, or something else — and why.