FDA Regulatory Pathway Selector

An interactive decision tree for selecting the right FDA regulatory pathway — 510(k), De Novo, PMA, or Exempt — for medical devices.

Starter Prompt

Create an interactive decision tree that helps medical device companies determine whether their device requires a 510(k), De Novo, PMA, or is FDA exempt, based on answers to questions about device class, risk, and predicate devices.

Expanded Prompt

Create a Claude Artifact called the FDA Regulatory Pathway Selector — an interactive step-by-step decision tool built with HTML, CSS, and JavaScript.

Goal

Guide medical device professionals through a structured series of questions to identify the most likely FDA regulatory pathway for their device. Replace the experience of manually reading through CFR parts and FDA guidance documents with a clean, interactive tool.

Audience

Medical device executives, regulatory affairs professionals, product managers, startup founders, and engineers entering the US market for the first time.

The Four Pathways

Decision Tree Logic

Walk users through questions in this sequence:

Step 1 — Device Classification

Is your device a Class I, Class II, or Class III device under 21 CFR?

• I’m not sure → Guide them to the FDA Product Classification Database
• Class I → Go to Step 2
• Class II → Go to Step 3
• Class III → Go to Step 5

Step 2 — Class I Exemption Check

Is your Class I device listed as exempt in 21 CFR Parts 862–892?

• Yes → Result: Exempt (general controls only apply)
• No → Result: 510(k) required

Step 3 — Predicate Device

Does a legally marketed predicate device exist with the same intended use and similar technological characteristics?

• Yes → Go to Step 4
• No → Go to Step 6

Step 4 — Substantial Equivalence

Does your device raise new questions of safety and effectiveness compared to the predicate?

• No → Result: 510(k)
• Yes → Go to Step 6

Step 5 — PMA Exemption Check

Has FDA approved a PMA or Product Development Protocol (PDP) for this device type, or is it reclassified?

• Yes, reclassified to Class II → Go to Step 3
• No → Result: PMA required

Step 6 — De Novo Eligibility

Is your device low-to-moderate risk, and could general and special controls provide reasonable assurance of safety and effectiveness?

• Yes → Result: De Novo request
• No → Result: PMA required

Result Display

For each outcome, show:

• Pathway name (large, prominent)
• Plain-English explanation of what the pathway means
• Typical timeline (e.g., 510(k): 3–12 months; PMA: 1–3+ years)
• Key submission requirements (brief bullet list)
• FDA resource link suggestion (e.g., “Visit FDA’s 510(k) Premarket Notification page”)
• A Start Over button

Design Requirements

• One question displayed at a time — clean, focused, uncluttered
• Progress indicator showing how far through the decision tree the user is
• Large, clear answer buttons
• Smooth transitions between steps
• Professional color palette suited for a regulatory or legal context
• Mobile-friendly
• A Back button on every step

Disclaimer

This tool provides general educational guidance only. Regulatory pathway determinations are complex and fact-specific. Always consult with a qualified regulatory affairs professional or FDA directly before making submission decisions.

Tips for Refining

• “Add a section for EU MDR pathways as a comparison”
• “Add more detail to the De Novo result explaining when it was introduced”
• “Add a summary PDF export of the pathway selected and the answers given”
• “Extend the tree to cover IVD devices under IVDR”