We support medical device and IVD manufacturers through the 510(k), from choosing the predicate through test planning and eSTAR to the FDA decision. Substantial equivalence needs the predicate's intended use and, for each technological difference, data showing it raises no different questions of safety or effectiveness.
Overview
510(k) premarket notification for medical devices and IVD · 21 CFR 807.81 to 807.100 · FD&C Act Sec. 513(i) · FDA guidance on substantial equivalence, Special and Abbreviated 510(k), eSTAR and the review clock
Last updated: October 30, 2026
FDA reviews a 510(k) in fixed steps against a predicate. It asks for the same intended use, for the same or different technological characteristics and, where they differ, whether they raise different questions of safety and effectiveness (21 CFR 807.100(b)). Each step has its own breaking point.
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Search for possible predicates by product code, classification regulation and FDA's 510(k) database, review of the published 510(k) summaries and indications for use, choice of a primary predicate and, where needed, additional predicates or reference devices with a rationale. Deliverable: a predicate rationale that also names the rejected candidates.
Side-by-side comparison of intended use, indications for use and technological characteristics (design, material, chemical composition, energy source) with the predicate, in the table format the SE guidance recommends. Each difference gets the question whether it raises different questions of safety and effectiveness, and the data that answer it.
Deriving the evidence from the differences to the predicate: bench testing, biocompatibility, software and, for IVD, analytical performance, comparison studies and reference ranges. Each standard is checked against the version FDA recognizes before a declaration of conformity is planned. Deliverable: a test plan that ties every test to a difference or a guidance document.
Building the 510(k) in eSTAR with a 510(k) summary under 21 CFR 807.92 or a statement under 807.93, the truthful and accuracy statement and the information on clinical investigations under 807.87(j). Before submission we check against FDA's technical screening: do the answers describe the device accurately, and is there a relevant attachment for each attachment question?
Support through Substantive Interaction, Interactive Review and additional information requests: each deficiency with a response, evidence and its location in the file, submitted as a complete response within the 180 days. After an NSE decision, an assessment of whether a new 510(k) with different data, De Novo or PMA is the way forward.
How we work together
A 510(k) must be submitted under 21 CFR 807.81 at least 90 days before the device is first marketed. FDA answers with one of four actions: the device is substantially equivalent to a predicate, it is not, FDA needs more information, or no 510(k) is required (21 CFR 807.100(a)). Marketing may start only after the SE order.
The order is not an approval. 21 CFR 807.97 states that an SE determination does not in any way denote official approval of the device. What FDA reviews is a comparison: its SE guidance of July 28, 2014, lays it out as a flowchart with decision points, from the predicate through intended use and technological characteristics to performance data.
| Traditional 510(k) | Special 510(k) | Abbreviated 510(k) | |
|---|---|---|---|
| For what | any 510(k) that uses neither of the other two forms | a change to your own cleared device | a device for which FDA guidance, special controls or recognized standards exist |
| What carries it | full performance data for the comparison with the predicate | results from design controls, reviewable as a summary or risk analysis | summary reports or a declaration of conformity |
| What FDA says | decision goal: 90 FDA days (MDUFA V) | review generally within 30 days; unsuitable cases become a Traditional 510(k) | the same content under 21 CFR 807.87 as any 510(k) |
Since October 1, 2023, a 510(k) is submitted as an eSTAR. Instead of an acceptance review under the refuse to accept guidance, FDA checks the eSTAR in a technical screening, intended within 15 days. Substantive Interaction follows and, where needed, an additional information request, during which the clock stops.
Outside this page are the choice between 510(k), De Novo and PMA on the page FDA Strategy & Pathways, the question of whether a change requires a new 510(k), and preparation for FDA inspections under the QMSR.
Our approach
Step
Result
Choose the predicate
A primary predicate with the same intended use, legally marketed within the meaning of 21 CFR 807.92(a)(3), and a written rationale for the choice.
Compare and plan tests
A comparison table against the predicate and a test plan in which every technological difference has a test or a rationale.
Submit the eSTAR
A complete eSTAR that passes technical screening; the review clock runs from the day of receipt.
Support the review
Answered Substantive Interaction and additional information requests, each response complete and with its location in the file.
Act on the decision
An SE decision as the condition for marketing or, after an NSE decision, a reasoned next pathway.
Common pitfalls
The indications for use are drawn wider than the predicate's.
Where they differ, 21 CFR 807.92(a)(5) requires the 510(k) summary to explain why the differences are not critical to the intended use; if the result is a new intended use, the SE guidance leads to an NSE decision that no test data can fix.
A Special 510(k) is submitted for a change that has no well-established method to evaluate it.
FDA then converts it to a Traditional 510(k) and notifies the submitter (Special 510(k) guidance, September 13, 2019); the review within 30 days that the guidance names for Special 510(k)s does not apply.
The response to an additional information request comes in pieces.
The review clock resumes only with a complete response to all deficiencies (review clock guidance, October 3, 2022); a partial response uses up time from the 180 days without moving the review forward.
The clearance is advertised as “FDA approval.” An SE determination does not denote official approval of the device, and any representation that creates that impression is misbranding (21 CFR 807.97).
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
Regulatory Change Assessment & Notification →
Whether a change to a cleared device requires a new 510(k)
Health Authority Interaction →
Pre-Submission meetings with FDA before the submission
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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