Usage Examples
- There is no predicate for this sensor, so the route is a De Novo Classification Request, not a 510(k).
- FDA granted the De Novo and codified special controls for the new device type.
- The De Novo got a refuse-to-accept because we filed it while the 510(k) was still open.
What is De Novo Classification Request?
De Novo Classification Request is an FDA premarket submission that asks the agency to classify a novel device into class I or class II when no legally marketed device exists to support a 510(k) substantial equivalence review.
De Novo Classification Request exists because the 510(k) route breaks down when there is nothing to compare against. A genuinely novel device has no legally marketed device on which to base a substantial equivalence review, so equivalence cannot be argued at all. 21 CFR Part 860 Subpart D gives FDA a way to classify such a device into class I or class II on its own evidence rather than leaving it in the highest-risk bucket by default.
De Novo covers devices that meet the class I or class II definitions in section 513(a)(1) of the FD&C Act and 21 CFR 860.3, and only those. It does not cover devices with an available predicate, which belong in a 510(k), nor devices whose risk profile requires class III controls, which belong in a PMA. Once granted, the classification creates the legally marketed device that later comparable products can compare themselves to.
De Novo requests are built around a classification argument, not an equivalence argument. The requester documents the searches showing no legally marketed device exists, summarizes the probable risks and the mitigation proposed for each, and proposes the special controls that make class II defensible. FDA then decides whether general controls, or general and special controls, give reasonable assurance of safety and effectiveness for the device type.
Not to be confused with
- 510(k)
- a 510(k) argues the device is substantially equivalent to a legally marketed predicate. A De Novo Classification Request argues that no such predicate exists and asks FDA to classify the device on its own data. Different burden, different evidence package.
- PMA
- PMA applies to class III devices and demands independent proof of safety and effectiveness. Choosing De Novo is itself a claim that the device fits the class I or class II definitions, and FDA will test that claim before it tests the data.
- Not Substantially Equivalent (NSE) determination
- an NSE is FDA's answer to a 510(k), not a submission type. It is one of the two situations that lead to a De Novo request under 21 CFR 860.200; the other is going straight to De Novo without filing a 510(k) at all.
- Reclassification petition
- a reclassification petition moves a device type that is already classified into a different class. A De Novo Classification Request classifies a device type that has never been classified.
The obligations sit in 21 CFR Part 860 Subpart D. These are the ones that decide whether the request survives its first two weeks.
What you must do
- 1Confirm the device meets the class I or class II definitions and that no legally marketed device exists on which to base a substantial equivalence review, before committing to this route21 CFR 860.200
- 2Submit the request as a single version in electronic format, in English, signed by the requester, and designated "De Novo Request" in the cover letter21 CFR 860.210
- 3Include the full content set: table of contents, administrative information, regulatory history, device description, indications for use, classification summary with the search rationale, risk and mitigation summary, benefit-risk discussion, nonclinical and clinical study summaries with technical sections, consensus standards references, labeling, and bibliography21 CFR 860.220
- 4Propose the special controls and explain how they, together with general controls, provide reasonable assurance of safety and effectiveness whenever class II is the recommendation21 CFR 860.220
- 5Justify any omitted content item explicitly rather than dropping it silently, because every item is mandatory unless the omission is justified in the request21 CFR 860.220
- 6Clear the refuse-to-accept triggers before filing, since FDA notifies acceptance within 15 days: no open premarket submission for the same device, no missing items, correct format, one device type per request, and prior deficiencies addressed21 CFR 860.230
Common mistakes
Filing a 510(k) first to "see what happens"
an NSE determination is not a free look. It consumes a review cycle and months of calendar time, and the De Novo request still has to be rebuilt from scratch as a classification argument rather than an equivalence argument. When the classification search already shows no legally marketed device, go direct.
Proposing special controls that restate general controls
controls phrased as "the device shall be safe" or that repeat existing obligations give FDA nothing to grant class II on. Special controls must be specific enough to stand as the standing requirements for the whole device type, because every later device in that type will be measured against them.
Treating the acceptance review as a formality
refusal to accept is triggered by mechanical defects: an open premarket submission for the same device, a missing content item, improper format, more than one device type bundled into one request, or deficiencies FDA already raised and the requester never addressed. Each one costs a full cycle before substantive review even begins.
When This Matters
- There is no predicate for this sensor, so the route is a De Novo Classification Request, not a 510(k).
- FDA granted the De Novo and codified special controls for the new device type.
- The De Novo got a refuse-to-accept because we filed it while the 510(k) was still open.
Frequently Asked Questions
A 510(k) compares a device to a legally marketed predicate; a De Novo Classification Request is used when no such device exists to base a substantial equivalence review on. 21 CFR 860.200 frames De Novo as the route for exactly that gap, classifying the device into class I or class II on its own evidence.
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