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De Novo & Breakthrough Pathways

Name: De Novo & Breakthrough Pathways
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Novel and expedited FDA pathways for devices with no predicate or that address unmet needs, plus Q-Submission and Pre-Submission mechanics.

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1

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 pathway for novel low- to moderate-risk devices with no predicate.
2

Regulatory

Breakthrough Device Designation(BDD)

FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.

Why this term here: Designation that unlocks expedited FDA interaction, not a separate submission type.
3

Commercialization

Pre-Submission Meeting(Q-Sub)

Formal FDA feedback request prior to a marketing or IDE submission.

Why this term here: The most valuable free tool FDA offers: written feedback before you file.
4

Regulatory

Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub)

Voluntary mechanism to obtain FDA feedback before a formal premarket submission.

Why this term here: The umbrella program that contains Pre-Sub, Study Risk Determination, and more.
5

Regulatory

Intended Use

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

Why this term here: The single sentence that anchors your whole regulatory strategy.
6

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 clinical situations your device is labeled for; drives evidence requirements.
7

Regulatory

Predicate Device

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

Why this term here: Why De Novo exists: what you file when no acceptable predicate is available.
8

Regulatory

Substantial Equivalence(SE)

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

Why this term here: The 510(k) test you cannot meet, which is why you're reading this path.
9

Regulatory

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

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

Why this term here: Compare to see why De Novo is different in evidence and outcome.
10

Regulatory

Premarket Approval(PMA)

FDA's most stringent device marketing application, required for high-risk Class III devices.

Why this term here: Where you end up if FDA decides your device belongs in Class III instead.
11

Regulatory

Combination Product

Product comprised of two or more regulated components - e.g., drug-device, biologic-device.

Why this term here: Extra Center-assignment step for device + drug or device + biologic products.

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De Novo & Breakthrough Pathways

De Novo Classification Request(De Novo)

Breakthrough Device Designation(BDD)

Pre-Submission Meeting(Q-Sub)

Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub)

Intended Use

Indications for Use(IFU (statement))

Predicate Device

Substantial Equivalence(SE)

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

Premarket Approval(PMA)

Combination Product