Usage Examples
- We cannot ship the design change under a letter to file; that is a new 510(k).
- The predicate shares our technological characteristics but not our intended use, so substantial equivalence will not close.
- The 510(k) has to be in eSTAR through the CDRH Portal, not an eCopy.
What is 510(k) Premarket Notification?
A 510(k) premarket notification is the FDA submission that clears a medical device for US marketing by proving substantial equivalence to a legally marketed predicate device, not by proving safety and effectiveness from scratch.
A 510(k) premarket notification exists because a device that mirrors something already legally marketed does not need its safety and effectiveness rebuilt from first principles. The cheaper and faster question is comparative: is this device equivalent to one already sold? A 510(k) is the mechanism that forces a manufacturer to ask and answer that question, in writing, before commercial distribution starts.
A 510(k) covers manufacturers required to register their establishment who are introducing a device into interstate commerce for commercial distribution, plus devices already distributed that are about to be significantly changed. A 510(k) does not cover devices FDA has exempted from premarket notification, and it never substitutes for premarket approval where the statute requires that pathway instead.
A 510(k) is built around one argument: same intended use, and either the same technological characteristics or different ones that raise no different questions of safety and effectiveness. Teams assemble proposed labeling, a device description, a predicate comparison, and performance data into eSTAR, then defend the equivalence argument through FDA's review questions until the substantial equivalence determination issues.
Not to be confused with
- PMA (premarket approval)
- a PMA requires independent evidence that the device itself is safe and effective. A 510(k) requires only that the device match a predicate. Different evidence burden, different outcome: an approval order versus a substantial equivalence determination.
- De Novo
- De Novo is the route taken when no predicate exists. A 510(k) fails at the threshold in that situation, because substantial equivalence has nothing to be equivalent to.
- Substantial equivalence
- substantial equivalence is the legal standard the submission must meet under 21 CFR 807.100(b). The 510(k) is the submission that argues it. FDA grants or denies substantial equivalence; it does not grant a 510(k).
- Establishment registration and device listing
- registration under § 807.20 and device listing tell FDA that a facility and a product exist. A premarket notification is a separate obligation, triggered by distribution of a specific device, and registration status alone clears nothing.
The obligations sit in 21 CFR Part 807 Subpart E, plus the electronic submission mandate.
What you must do
- 1Submit the premarket notification at least 90 days before introducing or delivering the device into interstate commerce for commercial distribution21 CFR 807.81(a)
- 2Submit a new premarket notification before a device already in commercial distribution is significantly changed or modified in design, components, method of manufacture, or intended use21 CFR 807.81(a)
- 3Include proposed labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use, together with either a 510(k) summary or a 510(k) statement21 CFR 807.87
- 4Write the 510(k) summary in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence21 CFR 807.92(a)
- 5Establish the same intended use as the predicate, and either the same technological characteristics or different characteristics that do not raise different questions of safety and effectiveness21 CFR 807.100(b)
- 6File the submission electronically using eSTAR unless exemptedFDA eSTAR Program, mandatory 2023-10-01
Common mistakes
Absorbing a significant change into a letter to file
21 CFR 807.81(a) requires a new premarket notification before a device in commercial distribution is significantly changed in design, components, method of manufacture, or intended use. Calling that judgement wrong means the device ships without the clearance it needs, and the correction is a retroactive filing made under scrutiny.
Picking a predicate on technology instead of intended use
substantial equivalence closes only when the intended use matches (21 CFR 807.100(b)). A predicate chosen because the technology looks similar, but cleared for a different indication, cannot carry the argument. The mismatch usually surfaces after the performance testing budget is already spent.
Reading the 90-day rule as a review clock
21 CFR 807.81(a) sets a filing deadline: the submission goes in at least 90 days before distribution begins. It is not a commitment that FDA finishes reviewing in 90 days. Launch plans built backwards from that assumption slip, and the slip is discovered late.
When This Matters
- We cannot ship the design change under a letter to file; that is a new 510(k).
- The predicate shares our technological characteristics but not our intended use, so substantial equivalence will not close.
- The 510(k) has to be in eSTAR through the CDRH Portal, not an eCopy.
Frequently Asked Questions
A predicate is the legally marketed device to which the submitter claims equivalence, identified in the 510(k) summary under 21 CFR 807.92. Substantial equivalence closes only if that predicate shares the new device's intended use and either its technological characteristics or characteristics raising no different safety and effectiveness questions.
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