FDA · Basic · 12 min lesson
Choosing the pathway - premarket notification, substantial equivalence, predicates and the alternatives
FD&C Act sections 510(k), 513(f)(2), 513(i) and 515; 21 CFR 807.81 and 807.100; Traditional, Special and Abbreviated 510(k); De Novo; PMA; MDUFA fees
What you will learn
- Explain what a premarket notification must show and apply the substantial equivalence test of 21 CFR 807.100(b).
- Choose and defend a predicate, separate it from reference devices, and tell intended use from indications for use and technological characteristics.
- Pick between Traditional, Special and Abbreviated 510(k), De Novo and PMA, and record the decision with the fee consequences.
Key takeaways
- A 510(k) is a premarket notification: you may not market the device until FDA issues a substantial equivalence order (21 CFR 807.100(a)).
- Substantial equivalence needs the same intended use and either the same technological characteristics or different ones that raise no different questions of safety and effectiveness (21 CFR 807.100(b)).
- A predicate carries the equivalence claim; reference devices only support individual points such as a test method or a feature.
- Intended use is the general purpose; indications for use are the specific condition and population. A new intended use cannot be bridged by a 510(k).
- No suitable predicate: consider De Novo for low and moderate risk, PMA for high risk. Record the decision and the rejected options.
- Fees depend on the pathway and company size; the FY2026 standard 510(k) fee was 26,067 US dollars. Check the current year before budgeting.
Free practice question
Norvik's pump is cleared nowhere. Its nearest competitor is cleared for irrigating superficial wounds only. Norvik will claim irrigation of deep surgical cavities and plans a Traditional 510(k) citing that competitor.
What does the substantial equivalence test say about this plan?
It passes, because both devices irrigate fluid.
Not quite. Sharing a function is not enough; 21 CFR 807.100(b) compares the intended use as claimed, including the clinical purpose.
The intended use differs, so this predicate fails the first limb and another route must be assessed.
Correct. Section 807.100(b) requires the same intended use; irrigating deep cavities is a different purpose from superficial wounds.
It passes if the labeling copies the predicate's words.
Not quite. Copying words conceals the true purpose, and the truthful and accurate statement in 21 CFR 807.87 would be breached.
It passes because FDA decides intended use after submission.
Not quite. The applicant defines the intended use, and 21 CFR 807.100(b) tests it from the submission, not from later negotiation.
Key terms
- 510(k): A premarket notification showing a device is substantially equivalent to a legally marketed device (FD&C Act section 510(k); 21 CFR 807).
- substantial equivalence: Same intended use, and same or different technological characteristics that raise no different questions of safety and effectiveness (21 CFR 807.100(b)).
- predicate device: The legally marketed device to which equivalence is claimed.
- reference device: A device cited to support a particular point, such as a feature or test method, without carrying the equivalence claim.
- indications for use: The disease or condition and patient population the device is for; narrower than intended use.
- De Novo: A route to classify a novel low or moderate risk device that has no predicate (FD&C Act section 513(f)(2)).
- PMA: Premarket approval, the route for class III devices (FD&C Act section 515).
Official sources
- FDA - Premarket Notification 510(k)
- 21 CFR Part 807 Subpart E - Premarket Notification Procedures
- 21 CFR 807.100 - FDA action on a premarket notification
- FDA - Medical Device User Fee Amendments (MDUFA) fees
- 21 CFR 807.87 - Information required in a premarket notification
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.