Every question and outcome
What best describes your device?
- Hardware instrument or equipment used outside the body
- Surgical instrument or tool
- Implant or device placed inside the body
- Software, mobile app, or AI algorithm
- In vitro diagnostic — a test run on a specimen
- Material, dressing, or single-use consumable
What does it do for the patient?
- Treats, mitigates, or prevents a disease or condition
- Diagnoses a condition, or informs a diagnosis
- Monitors or measures a physiological parameter
- Supports or sustains life
- Only stores, displays, or transfers data — no interpretation
- General wellness, fitness, or lifestyle only
How does it contact the patient?
- No patient contact
- Intact skin only
- Mucous membrane or broken skin
- Enters the body, less than 24 hours
- Stays in the body 24 hours to 30 days
- Permanent implant, over 30 days
If it fails or is misused, what’s the worst realistic outcome?
- Death or permanent serious injury
- Serious injury the patient recovers from
- Minor or reversible injury
- No meaningful harm to the patient
Is there a similar device already legally marketed in the US?
- Yes — I can name an FDA-cleared device that does essentially the same thing
- Similar devices exist, but I don’t know if they’re cleared
- Nothing like it is on the US market
- It’s a modification of a device I already have cleared
Where is your company based?
- United States
- Outside the United States
Likely not a device
On the answers given, this product may fall outside FDA’s device definition altogether, so there is no class to assign.
With no device, there is no premarket pathway — no 510(k), no registration, no listing.
- A product is a device under FD&C Act 201(h) only when it is intended to diagnose, cure, mitigate, treat or prevent disease, or to affect the structure or any function of the body. Intended use is set by labeling, advertising and promotional claims, not by what the technology could do.
- Software that only stores, displays, or transfers data without interpreting it is carved out of the device definition by FD&C Act 520(o)(1), and FDA’s general wellness policy sets out where the line sits for low-risk lifestyle products.
One sentence of marketing copy. The moment any material claims the product detects, diagnoses, treats, monitors or mitigates a specific condition, it becomes a device and every answer above changes.
An AI or algorithmic feature that interprets data, rather than presenting it, also takes software out of the 520(o)(1) carve-out.
Special 510(k)
The class does not change: a modification to your own cleared device stays in the class the original was assigned.
The route is a Special 510(k), the abbreviated pathway for a change to a device you already have cleared.
- A Special 510(k) is available where the change can be verified and validated through your existing design control procedures, the methods are well established, and the results can be reviewed in a summary format.
- The user fee is the same as a Traditional 510(k): $28,653 for FY2027, or $7,163 as a qualified small business.
- The submission is built in eSTAR like any other 510(k), and the design control records behind the change are what the review turns on.
- Where a change is significant enough to affect safety or effectiveness but does not fit the Special criteria, it becomes a Traditional 510(k) rather than no submission at all (21 CFR 807.81(a)(3)).
A change to intended use or to the indications for use is never a Special 510(k). That is a Traditional 510(k), whatever else stays the same.
A change whose verification needs new clinical data, or methods that are not well established, also falls back to a Traditional 510(k).
Class III · PMA
A device that can cause death or permanent serious injury, sustains life or is permanently implanted, with nothing comparable legally marketed, sits in Class III.
Class III devices reach the market through premarket approval under FD&C Act 515 — the most demanding route, and the only one that requires FDA to approve rather than clear.
- A PMA is carried by valid scientific evidence that the device is safe and effective for its intended use, which usually means clinical investigation data rather than bench and animal testing alone (21 CFR 814.20).
- The user fee is $636,732 for FY2027. A qualified small business pays a quarter of that, and a first PMA may be waived entirely below the statutory receipts threshold.
- An advisory panel meeting is possible, and a manufacturing site inspection is part of the review rather than an afterthought.
- Approval carries continuing conditions: annual reports, and a supplement for changes affecting safety or effectiveness.
A small number of pre-1976 Class III device types still reach the market through a 510(k) because FDA has not yet called for PMAs. Confirming the product code settles this before any budgeting.
If general and special controls would in fact give reasonable assurance of safety and effectiveness, De Novo classification is the route instead — and that judgment belongs to the specific device, not the category.
Class II or III
This risk profile straddles the Class II and Class III line, and the answers given do not settle which side it falls on.
The pathway follows from the class: substantial equivalence for Class II, premarket approval for Class III. The classification regulation for the matching generic type is what decides.
- The product code carries the class, and the product code belongs to a generic device type matched on intended use. Searching FDA’s Product Classification Database for that type is the step that resolves this.
- Where the database is genuinely ambiguous, a 513(g) request buys FDA’s view in writing: $8,596 for FY2027, and FDA responds within 60 days.
- Life-sustaining and permanently implanted devices are treated as high risk by default, so the burden runs the other way here — the case for Class II has to be made rather than assumed.
Naming a legally marketed device with the same intended use settles this as Class II and a Traditional 510(k).
Finding no such device, at this risk profile, points at premarket approval — or at De Novo if general and special controls would be enough.
De Novo
With nothing comparable legally marketed there is no predicate, so there is nothing to be substantially equivalent to and no existing classification to inherit.
De Novo classification asks FDA to create the classification for a device of low to moderate risk (FD&C Act 513(f)(2)).
- The user fee is $191,020 for FY2027 — 30% of the premarket application fee — with a quarter of that for a qualified small business.
- eSTAR has been mandatory for De Novo requests since October 2025.
- The request has to show that general controls, or general plus special controls, give reasonable assurance of safety and effectiveness. Naming the special controls the device type would need is part of the argument, not an afterthought.
- A granted request creates the classification regulation and the product code — which makes your device the predicate everyone after you cites.
A predicate the search missed. If a device with the same intended use has in fact been cleared, this is a Traditional 510(k), and redoing the predicate search is the first thing worth the time.
If the risk cannot be controlled by general and special controls, De Novo is not available and the route is premarket approval.
Class I · likely exempt
Low consequence of failure, no more than intact skin contact, and no diagnostic or therapeutic claim points at Class I.
Most Class I device types are exempt from premarket notification, which means no 510(k) — but not no obligations.
- Establishment registration and device listing still apply, and registration renews every year between 1 October and 31 December (21 CFR 807). Devices from an unregistered establishment are misbranded.
- Labeling requirements under 21 CFR 801 apply in full, as does adverse event reporting under 21 CFR 803.
- Class I devices are exempt from most of the quality system regulation, but not from its recordkeeping and complaint-handling requirements (21 CFR 820).
- Confirm the exemption against the specific classification regulation before relying on it — the exemption belongs to the generic device type, not to your device.
The limitations section, and this is the one that catches people. Every classification part carries one numbered 8xx.9 — 21 CFR 862.9, 878.9, 888.9 and so on. A device otherwise exempt still requires a 510(k) if it is intended for a use different from the generic type, or if it operates using a different fundamental scientific technology. FDA’s own example is a surgical instrument that cuts with a laser beam rather than a sharpened blade.
Adding a diagnostic or therapeutic claim moves the device out of this answer entirely.
Predicate search first
The class most likely lands in Class II, but the answers given do not confirm it — whether a comparable device has actually been cleared is the open question.
The pathway hangs on the same fact: a cleared device with the same intended use means a 510(k); none means De Novo.
- Search FDA’s 510(k) database by product code rather than by brand or company. Device names in FDA’s records are frequently not the name a manufacturer uses, so a broader term usually works better.
- A search result is not a predicate. A valid predicate has the same intended use as your device, and the comparison between the two is what the submission turns on.
- How well trodden the path is matters: a product code with a thousand clearances is a different proposition from one with three.
Finding a cleared device with the same intended use makes this a Traditional 510(k), and the predicate choice becomes the central decision.
Finding nothing with the same intended use makes this a De Novo request instead.
Class II · 510(k)
Moderate risk, with a comparable device already legally marketed, is the standard Class II picture.
The route is a Traditional 510(k): a premarket notification demonstrating substantial equivalence to that predicate.
- Identify the predicate: a legally marketed device with the same intended use. The predicate choice is the decision the whole submission rests on (21 CFR 807.92).
- Generate the performance data that shows your device is as safe and effective as the predicate, and that any technological difference raises no new questions of safety or effectiveness (FD&C Act 513(i)).
- Build the submission in eSTAR, mandatory for 510(k)s since 1 October 2023.
- Pay the MDUFA user fee: $28,653 for FY2027, or $7,163 with a granted Small Business Determination. The determination is not retroactive, so it has to be granted before you submit.
- FDA screens the submission within 15 days, then works to a review goal of 90 FDA days. FDA days are not calendar days — the clock stops while the submission sits on hold for an Additional Information request.
The predicate’s indications for use. If they differ from yours, FDA can find the device not substantially equivalent — which points at De Novo rather than at a fixable submission.
A different fundamental scientific technology from the predicate raises new questions of safety and effectiveness, and the data needed to answer them is often what decides whether the pathway holds.
If the matching classification regulation turns out to exempt the device type, the 510(k) may not be needed at all — subject to the 8xx.9 limitations.
This follows FDA’s published classification rules, applied to the answers given. It is not a classification determination, and it does not assign a product code — the code belongs to a generic device type, matched on intended use. FDA’s own view in writing comes from a 513(g) request.