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510(k) Fundamentals

Name: 510(k) Fundamentals
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From predicate selection to substantial equivalence to RTA - the core 510(k) toolkit.

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1

Regulatory

510(k) Premarket Notification(510(k))

FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.

Why this term here: The pathway itself. Focus on what a 510(k) is and, just as importantly, what it is not (it is not an approval).
2

Regulatory

Predicate Device

A legally marketed device used as the comparator in a 510(k) submission.

Why this term here: The whole submission hinges on this choice. Focus on how to pick a predicate that supports your claims without expanding indications.
3

Regulatory

Substantial Equivalence(SE)

The legal standard a 510(k) device must meet versus a predicate.

Why this term here: The legal standard FDA applies. Focus on the decision tree of intended use, technological characteristics, and safety/effectiveness.
4

Regulatory

Intended Use

The objective intent of the manufacturer regarding the use of the device.

Why this term here: The regulatory anchor for your device. Focus on why this differs from marketing language and why edits later are painful.
5

Regulatory

Indications for Use(IFU (statement))

Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate.

Why this term here: The specific patient population and condition. Focus on the difference between intended use and indications, and how each is worded.
6

Regulatory

Refuse to Accept(RTA)

FDA administrative decision that a submission is incomplete and won't be substantively reviewed.

Why this term here: The first hurdle after submission. Focus on the checklist items that most commonly trigger a hold.
7

Regulatory

De Novo Classification Request(De Novo)

Pathway to classify novel low- to moderate-risk devices that lack a predicate.

Why this term here: The alternative when there is no predicate. Focus on when De Novo beats forcing a weak 510(k).

Finished the path? Test yourself with a quiz tailored to these 7 terms.

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510(k) Fundamentals

510(k) Premarket Notification(510(k))

Predicate Device

Substantial Equivalence(SE)

Intended Use

Indications for Use(IFU (statement))

Refuse to Accept(RTA)

De Novo Classification Request(De Novo)