Getting a 510(k) Right: Predicate, Evidence and Change Control
Pick the right predicate, show substantial equivalence with real data, and decide on the record when a change needs a new 510(k).
In Short
- Submit 90 days before marketing.
- Equivalence needs evidence.
- Record every change decision.
The Medical Device Production Guide
Built to revision. Inspected. On record.
- What the QMSR changed in February 2026
- Supplier to finished build
- Inspect, review, correct
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The Medical Device Production Guide
Built to revision. Inspected. On record.
A 510(k) asks FDA to agree that your device is substantially equivalent to a legally marketed predicate. Under 21 CFR 807.81 it is due at least 90 days before you begin commercial distribution, and again when a marketed device is significantly changed. This guide covers choosing a route and predicate, building the evidence and deciding about later changes. It is orientation, not regulatory advice. Sources checked 4 Oct 2026.
When a 510(k) is required
Section 807.81 requires a premarket notification when a device is introduced into commercial distribution for the first time, when a registered establishment first introduces a device, and when a marketed device is about to be significantly changed in design, components, manufacturing method or intended use. Many class I and some class II devices are exempt; confirm against the classification regulation for your product code before planning.
Choosing the Route and Predicate
A 510(k) needs a predicate: a legally marketed device of the same type. If none exists and risk is low to moderate, a De Novo request may fit.
Which route?
| Situation | Usual route |
|---|---|
| Same type as a legally marketed device | 510(k), unless exempt |
| Novel, low to moderate risk, no predicate | De Novo request |
| Class III | PMA |
| Exempt class I or II device | No 510(k); QMSR and other controls still apply |
- Same type as a legally marketed device
- Usual route
- 510(k), unless exempt
- Novel, low to moderate risk, no predicate
- Usual route
- De Novo request
- Class III
- Usual route
- PMA
- Exempt class I or II device
- Usual route
- No 510(k); QMSR and other controls still apply
More on choosing the Route and Predicate
Class III devices usually need a PMA. Choose a predicate with the same intended use and the closest technology, and record why you rejected alternatives. Weak predicate choice is a common reason for additional information requests.
Building the Equivalence Case
The submission compares intended use and technological characteristics, then supports any differences with performance data such as bench testing, biocompatibility, software documentation, electrical safety or sterilisation validation, as relevant. The device description, labeling and test reports must agree with each other and with what you will actually build.
More on building the Equivalence Case
FDA's current eSTAR template structures most submissions.
Changes after clearance
Every design, material, process or labeling change goes through change control. The question is whether the change could significantly affect safety or effectiveness, or is a major change in intended use.
Worked Example: a Material Change
- Week 1CR-207 proposes a new housing resinEngineering
- Week 2Impact assessed: biocompatibility and strengthQuality
- Week 3Decision recorded: new 510(k) neededRegulatory
- LaterChange released only after clearanceQuality
More on changes after clearance
FDA guidance on deciding when to submit a 510(k) for a change gives decision flowcharts. Record the assessment and the decision with its rationale, even when the answer is no; investigators ask for these files.
Quality System Links
Clearance does not replace the quality system. Under 21 CFR 820.10 most class II devices need ISO 13485 design and development controls, and production must follow the cleared design.
More on quality System Links
Keep the design and development file, risk management, verification and validation linked to the submission so a later change can be judged against what FDA cleared.
Questions
How early must we submit?
At least 90 days before you intend to begin commercial distribution, under 21 CFR 807.81. Review time varies; plan for questions.
Can we market while the 510(k) is under review?
No. You may not market the device in the US until FDA issues a clearance letter.
Does every change need a new 510(k)?
No. Only changes that could significantly affect safety or effectiveness, or major intended-use changes. Record the decision either way.
Where does V5 fit?
V5 keeps documents, change control with impact assessment and approvals, device production records and complaints. It does not choose a pathway, prepare the submission or decide equivalence.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.