We support medical device and IVD manufacturers through the De Novo request, from the search for a possible predicate to the FDA decision. The request must show that the device type is new and that general controls, for class II with special controls, address its risks.
Overview
De Novo classification for medical devices and IVD · FD&C Act Sec. 513(f)(2) · 21 CFR 860.200 to 860.260 · FDA guidance on the De Novo process, the De Novo eSTAR and benefit-risk determinations
Last updated: October 31, 2026
FDA reviews a De Novo request in two stages. First it asks whether the device type already exists, then whether general controls, or general and special controls, provide reasonable assurance of safety and effectiveness. The request can end at either stage; 21 CFR 860.260(c) lists eleven grounds for declining it.
Industries
Services
Search of classification regulations in 21 CFR Parts 862 to 892, product codes, 510(k)s, PMAs, HDEs, EUAs and granted De Novo requests, with the search terms on record. Deliverable: the classification summary under 21 CFR 860.220(a)(8), which explains for each similar device how your device type differs.
Mapping each known risk to health to a mitigation, separated into general and special controls, with a reference to the testing or labeling in the request that supports it. For class II, we write the draft special controls the way they later appear in the classification regulation: as requirements on data, software and labeling for the whole device type.
Planning the nonclinical and, where needed, clinical data that show the probable benefit outweighs the probable risk under the proposed controls (21 CFR 860.7, 860.220(a)(14)). Assessed against the factors in FDA's guidance of August 30, 2019: type, magnitude, probability and duration of benefit, severity, rates and duration of harm, and the uncertainty of the data.
Building the request under 21 CFR 860.220 in the De Novo eSTAR: regulatory history with all prior submissions, indications for use, device description, alternatives, classification recommendation, standards, study summaries and technical sections. Whatever does not apply to the device is listed as a justified omission in a separate section (21 CFR 860.220(c)).
Support through technical screening, interactive review and additional information requests, each response complete and within the 180 days of 21 CFR 860.250(a)(1). Preparation for an inspection before the decision under 21 CFR 860.240(c). After a decline, the assessment of whether a new request with more data, a 510(k) or a PMA is the way forward.
How we work together
A device of a new type is in class III by operation of law, regardless of its risk (FD&C Act Sec. 513(f)(1)). The De Novo request under Sec. 513(f)(2) is the way out: FDA classifies the device type into class I or II under the criteria of Sec. 513(a)(1) and thereby creates a classification regulation that did not exist before.
21 CFR 860.220(a) lists what the request must contain in 19 items. An item that is left out needs a justification; otherwise FDA may refuse the request at acceptance review (21 CFR 860.230(c)(1)(ii)).
| Part of the request | Content | 21 CFR 860.220(a) |
|---|---|---|
| Context | regulatory history, indications for use, device description, alternative practices and procedures | (3) to (7) |
| Classification | searches, similar devices, rationale for the difference; after an NSE determination, the 510(k) number and the search since then | (8) |
| Risks and controls | risks with mitigations, draft special controls, recommended class with rationale | (9) to (11) |
| Evidence | standards, study summaries, benefit and risk, technical sections with test reports | (12) to (15) |
| Other | literature, samples on request, labeling and advertisements | (16) to (19) |
21 CFR 882.5804 shows what the result looks like. The regulation identifies a device type in one sentence and sets class II with three special controls, one requirement each on clinical data, software verification and labeling. FDA had granted the request on May 9, 2023; the device type entered the CFR with the notice of June 26, 2026. A search limited to 21 CFR Parts 862 to 892 would have missed it for three years.
Outside this page are the choice between 510(k), De Novo and PMA on the page FDA Strategy & Pathways, the 510(k) itself, the qualification of a product as a medical device or IVD before the pathway choice, and preparation for FDA inspections under the QMSR.
Our approach
Step
Result
Clarify eligibility
A recorded search without a predicate, classification regulation or PMA for the device type, and the choice between a direct request and a prior 510(k).
Submit a Pre-Sub
FDA feedback on eligibility, risks, controls and test protocols before the studies begin.
Generate evidence
Nonclinical and, where needed, clinical data for each mitigation, with summaries under 21 CFR 860.220(a)(13).
Submit the request
An eSTAR that passes technical screening, with the classification recommendation and, for class II, the draft special controls.
Act on the decision
If granted, a new classification regulation whose special controls your device and every later 510(k) of the same type must meet; if declined, a reasoned next route.
Common pitfalls
Another manufacturer is faster.
If FDA grants a De Novo request for the same device type while yours is still under review, it declines yours under the De Novo guidance (October 5, 2021). The data can be incorporated by reference into a 510(k), which then names the first device as predicate and has to meet the new special controls.
Something else is still open for the same device.
FDA may refuse a De Novo request at acceptance review if another submission or a reclassification petition for the device is pending or deficiencies from earlier submissions remain unanswered (21 CFR 860.230(c)(1)(i) and (v)).
The special controls are written only for your own device.
After the grant they apply to the whole device type and are published with the classification in the Federal Register (21 CFR 860.260(a)(2)); your own next generation has to meet them in its 510(k) as well.
Labeling comes last.
Labels, labeling and advertisements are part of the request (21 CFR 860.220(a)(18)), and labeling that does not comply with 21 CFR Part 801 or, for IVD, Part 809 is a ground for declining in its own right (21 CFR 860.260(c)(3)).
Regulatory Affairs
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
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Projects from this industry
Latest insights
All insights →FDA Strategy & Pathways →
Choosing between 510(k), De Novo and PMA by classification and risk
510(k) Premarket Notification →
Predicate, substantial equivalence, tests, eSTAR and review of a 510(k)
Qualification & Classification →
Qualification and classification before the pathway choice, at FDA with a 513(g) request
Health Authority Interaction →
Pre-Submission meetings with FDA before the request
FDA Inspection Readiness & QMSR →
Preparing for FDA inspections under the QMSR
Briefly outline your situation. We'll respond with an initial assessment, usually within one business day.
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