USA
The United States does not classify by rules at all. A device is matched to one of several thousand generic types, and that type carries both the class and the premarket pathway.
This is the structural break in the site. Every other market here runs a cascade: answer questions about the device, apply the rules, read off a class. The FDA does not. It maintains a catalogue of generic device types in 21 CFR Parts 862 to 892, each identified by a three-character product code, and each carrying a classification regulation, a class and a premarket pathway. Classification in the United States therefore means finding the row your device belongs to — a judgement about what the device *is*, made against the catalogue, which no questionnaire can perform. That is why this market is a search on MDClassify and not an engine, and why the choice of code is left to you rather than presented as a result.
US classes run I to III, with no IIa or IIb, and they carry different consequences. A US Class II device is usually cleared through a 510(k) by showing substantial equivalence to an existing device — a comparison that has no EU counterpart at all. Class I devices are mostly exempt from premarket submission entirely. Nothing about the EU class predicts the US class, and the reverse is equally true.
NOTE —
| CLASS | RISK | INDEPENDENT REVIEW |
|---|---|---|
| I | Low | General controls; most are exempt from 510(k) |
| II | Moderate | Special controls; usually 510(k) |
| III | High | Premarket approval (PMA) |
By finding the generic device type it belongs to. The FDA publishes a catalogue of device types, each with a three-character product code and a classification regulation in 21 CFR. The code carries the class — I, II or III — and the premarket pathway. There is no rule cascade to apply.
That absence is itself informative. A device with no existing generic type is a candidate for the De Novo route, which requests classification of a genuinely new type. It is a different and longer process than a 510(k).
No. The code tells you the class and the pathway. A 510(k) additionally requires you to identify a predicate device and demonstrate substantial equivalence to it. Finding a code does not establish that a suitable predicate exists.
No, and treating it as a starting point is misleading. The two systems classify on different criteria — the EU on invasiveness and duration, the US on the generic type a device belongs to. Software classed IIa in the EU under Rule 11 may not be a regulated device in the United States at all.
The questionnaire classifies under the EU MDR; tick this market and you can search the product code catalogue from the result, and carry the entry you choose into the report.
