Submission Pathway Selector

Five questions → 510(k), De Novo, or PMA recommendation, with the cybersecurity evidence delta for each pathway under the FDA's Feb 3, 2026 final premarket guidance.

Is there a legally marketed predicate device with similar intended use and technological characteristics?

What is the device's risk class / probable level of patient harm?

Does the device introduce a new technological feature without a precedent (e.g. new modality, new biological interface, new AI claim)?

What clinical evidence will support safety and effectiveness?

What is the device's connectivity and software profile?

Is this a combination product or will it require an IDE for the clinical study?

If AI/ML is in scope: do you plan to ship adaptive updates after clearance?

Answers → pathway recommendation + cybersecurity delta per route

• Primary recommendation (510(k), De Novo, or PMA) with a plain-English rationale.
• Alternates listed when the call is close, so you walk into a Pre-Sub with options.
• Per-pathway cybersecurity evidence delta - what's identical and what's different.
• JSON export to hand to regulatory affairs.

What teams usually get wrong

• Myth: Cyber evidence is the same for 510(k) and PMA.

  Reality: The artifacts are largely the same; the depth, validation rigor, and Q-Sub interaction differ. PMA reviewers go deeper on threat-model traceability and clinical-risk linkage.

• Myth: De Novo means lighter cyber than 510(k).

  Reality: De Novo establishes a new classification - the FDA often sets the cyber bar high precisely because there's no predicate. Expect the full §524B package.

• Myth: Pathway is purely a regulatory decision; product security can wait.

  Reality: Pathway choice changes the Pre-Sub strategy for cybersecurity. Engage product security before pathway is locked.

Primary sources behind this tool

1. FDA 510(k) Premarket Notification - FDA
2. FDA De Novo Classification Request - FDA
3. FDA Premarket Approval (PMA) - FDA
4. FDA Cybersecurity in Medical Devices (Feb 3, 2026 final premarket guidance) - FDA
5. Q-Submission Program - FDA

Build the cyber evidence.