Medical Device Classification Procedures
Sets out how FDA classifies devices into class I, II or III, how classifications are changed, and, in Subpart D, the De Novo process for classifying a novel low- or moderate-risk device that has no predicate into class I or II.
What this does not cover
stated in the document's own scope- It does not set the content of a 510(k); that is in Part 807 Subpart E.
- It does not provide premarket approval for class III devices; Part 814 does.
- It does not impose manufacturing requirements, though De Novo review may include an inspection to check that Part 820 requirements give adequate assurance for critical or novel processes.
- A De Novo request covers a single device type; a request for devices of more than one type may be refused.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
Part 860 is how FDA classifies medical devices into class I, II or III and how those classifications change. Class determines the controls a device needs and, with it, the route to market. Subpart D, added in 2021, sets out De Novo classification: the process for a novel device of low or moderate risk that has no legally marketed predicate, so it cannot be cleared by 510(k), but whose risks general controls, or general and special controls, can manage. A granted De Novo creates a new classification regulation that later devices of the same type can rely on.
Scope & applicability
All devices intended for human use. Subpart D applies to a single device type for which there is no legally marketed device on which to base substantial equivalence, either after a not-substantially-equivalent 510(k) decision or directly (860.200).
Legal basis & how it acquires force
A regulation in Title 21 of the Code of Federal Regulations issued under section 513 of the FD&C Act, which defines the three device classes and provides for De Novo classification in section 513(f)(2). Subpart D was added by a final rule published on 5 October 2021 and in effect from 3 January 2022. The Part was last amended on 2 February 2026.
Document structure
| Part | Covers |
|---|---|
| Subpart A — General | Definitions, including the three classes, and how FDA determines safety and effectiveness (860.7) |
| Subpart B — Classification | Classification procedures and classification panels |
| Subpart C — Reclassification | How a classification is changed, by petition or on FDA’s initiative |
| Subpart D — De Novo Classification | Applicability (860.200), format (860.210), content (860.220), acceptance (860.230), review (860.240), withdrawal (860.250), and granting or declining (860.260) |
Key requirements
- §860.3 and §860.7 — the definitions of the three classes and how safety and effectiveness are determined
- §860.220 — De Novo request content, including the summary of risks and mitigations, proposed special controls and the recommended class with its justification
- §860.240 — an order granting or declining an accepted De Novo request within 120 days; FDA may inspect relevant facilities first
- §860.250 — a request is treated as withdrawn if a request for additional information is not fully answered within 180 days
- §860.260 — a granted request is published in the Federal Register, with its special controls, within 30 days
Implementation tips
- Write the special controls you propose as if they will become the regulation, because a granted De Novo makes them the controls every later 510(k) for that device type must meet
- Have the quality system ready before the request is granted: FDA may inspect to confirm that critical or novel manufacturing processes are under control
International alignment
Classification links the three premarket routes: a 510(k) under Part 807 relies on a predicate of the same type, a De Novo under this Part creates a new type, and class III devices generally need premarket approval under Part 814. FDA lists eSTAR as mandatory for De Novo submissions to CDRH and CBER unless exempted. A 513(g) request for information can ask FDA for its view of a device’s classification before a submission.
21 CFR Part 860: frequently asked questions
Quick answers to common questions about 21 CFR Part 860.
Who can file a De Novo request?
A sponsor whose device received a not-substantially-equivalent decision on a 510(k), or a sponsor who determines there is no legally marketed device on which to base substantial equivalence and files directly (21 CFR 860.200(b)).
How long does FDA have to decide?
FDA will grant or decline an accepted De Novo request within 120 days of receipt, or of the additional information that resulted in its acceptance (860.240(a)). It may inspect relevant facilities before deciding (860.240(c)).
What happens after a De Novo is granted?
FDA publishes a notice of the classification order, including any special controls, in the Federal Register within 30 days (860.260(a)(2)). The device can then serve as a predicate for 510(k) submissions for devices of the same type.
When is a De Novo request treated as withdrawn?
If the requester does not fully answer a request for additional information within 180 days, does not fully answer acceptance deficiencies within 180 days, refuses FDA a reasonable opportunity to inspect, or withdraws in writing (860.250(a)).