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Quick Start Guide

For First-Time Users

Step 1: Choose Your Format

Interactive Tool (Recommended for most users)

  • Download samd_decision_tree.html
  • Open in any web browser
  • Follow the step-by-step questions
  • Takes 5-10 minutes

Comprehensive Analysis (For detailed regulatory understanding)

  • Open regulatory_analysis_verified.md
  • Read through the two-step framework
  • Review regulatory citations
  • Reference as needed during IRB preparation

Step 2: Using the Interactive Tool

  1. Start with your software description

    • Have a clear intended use statement ready
    • Know who the end users will be (patients vs. clinicians)
    • Understand what clinical data it will use

  2. Answer honestly

    • The tool is educational, not enforcement
    • Better to discover issues now than during IRB review
    • You can go back and revise answers

  3. Take notes

    • Save or screenshot your results
    • Note the regulatory citations provided
    • Use these for your IRB submission

Step 3: What to Do With Results

If the tool says "Medical Device":

  • ✅ Plan for IRB review under 21 CFR 56
  • ✅ Determine if you need IDE (most likely yes)
  • ✅ Prepare device risk determination worksheet
  • ✅ Read the comprehensive analysis document

If the tool says "General Wellness":

  • ⚠️ Verify this carefully - most disease-specific tools are NOT general wellness
  • ✅ Review the disqualifying criteria
  • ✅ Still check with your IRB
  • ✅ Ensure all marketing aligns with wellness claims

If the tool says "NSR" (Nonsignificant Risk):

  • ✅ Prepare abbreviated IDE documentation
  • ✅ Document your risk mitigation protocols
  • ✅ Submit to IRB with clear justification
  • ⚠️ Remember: IRB makes final determination

If the tool says "SR" (Significant Risk):

  • ✅ Plan for full IDE submission to FDA
  • ✅ Allow extra time (FDA review takes months)
  • ✅ Consider pre-submission meeting with FDA
  • ✅ Develop comprehensive monitoring plans

Common Scenarios

Scenario 1: "We're Just Developing an Algorithm"

Important: Algorithm development for medical devices still requires IRB review!

  • The concept of "clinical evaluation" (IMDRF/FDA) is broader than "clinical investigation"
  • Development activities are part of clinical evaluation
  • IRB oversight applies to clinical evaluation, not just testing in humans

What to do:

  • Work through the decision tree
  • Pay special attention to the "clinical evaluation vs. clinical investigation" section
  • Prepare to explain this to colleagues who may be confused

Scenario 2: "Our Tool is Just Educational"

Important: Disease-specific education using clinical data is likely a medical device!

  • General wellness = population-level lifestyle advice
  • Medical device = personalized disease-specific recommendations using clinical data

What to do:

  • Go through the general wellness checkpoint carefully
  • Review the comparison table in the regulatory analysis document
  • Be prepared to classify as a device

Scenario 3: "Patients Will See the Output But Won't Act On It"

Important: Visibility can still create risk even with disclaimers!

What to do:

  • Document your risk mitigation protocols thoroughly
  • Consider requiring clinical confirmation before any action
  • Let the IRB evaluate if safeguards are adequate
  • Don't assume it's automatically NSR or SR

Tips for Success

Before Using the Tool

✅ Gather Key Information:

  • Written intended use statement
  • Description of input data (clinical? lifestyle? both?)
  • Description of outputs (advice? scores? both?)
  • Who will see outputs (patients? clinicians? both?)
  • Study procedures (what actually happens in this study phase?)

✅ Understand Your Project Stage:

  • Algorithm development with synthetic data?
  • Validation with real data but outputs hidden?
  • Testing where outputs are visible?
  • Deployment in clinical care?

While Using the Tool

✅ Read the Information Boxes:

  • Blue boxes explain key concepts
  • Amber boxes show disqualifying criteria
  • They contain important regulatory distinctions

✅ Don't Rush:

  • Think carefully about each question
  • The questions are precisely worded for regulatory accuracy
  • Ambiguous answers lead to ambiguous outcomes

✅ Use the Back Button:

  • Exploring different pathways is educational
  • See how different answers lead to different outcomes
  • This helps understand the regulatory framework

After Using the Tool

✅ Verify Your Understanding:

  • Review the comprehensive analysis document
  • Look up the cited regulations (links provided)
  • Discuss with your IRB before assuming the classification

✅ Prepare Your IRB Submission:

  • Include the regulatory framework from this tool
  • Cite specific CFR sections
  • Provide clear justification for NSR/SR determination
  • Document risk mitigation protocols

✅ Be Ready for Questions:

  • IRB may disagree with your classification
  • Be prepared to provide additional safeguards
  • Approach it collaboratively

Red Flags to Watch For

🚩 "We think it's general wellness because it's educational"

  • Most disease-specific educational tools are medical devices
  • Using clinical data for personalized recommendations = device

🚩 "We don't need IRB review because we're not testing in humans yet"

  • Clinical evaluation ≠ clinical investigation
  • Development activities for medical devices require IRB oversight

🚩 "It's obviously NSR because we're just developing it"

  • Depends on study procedures, not just development stage
  • If outputs are visible and could influence care, may be SR

🚩 "The FDA won't care about our small academic project"

  • FDA regulations apply regardless of project size
  • IRB reviews all device studies under 21 CFR 56

Getting Help

If you're unsure after using the tool:

  1. Review the comprehensive analysis document
  2. Check the FDA guidance documents linked in references
  3. Consult with your IRB early
  4. Consider engaging a regulatory consultant

If you find an error or ambiguity:

  1. Open an issue on GitHub
  2. Provide specific regulatory citations
  3. Suggest a correction

Most Common Mistakes to Avoid

  1. ❌ Assuming "educational" = "not a device"
  2. ❌ Thinking general wellness includes disease-specific tools
  3. ❌ Believing development phase doesn't need IRB review
  4. ❌ Assuming NSR just because no patients harmed yet
  5. ❌ Ignoring the need for risk mitigation documentation

Success Checklist

Before your IRB submission:

  • Completed the decision tree
  • Read the relevant sections of the analysis document
  • Reviewed cited FDA guidance
  • Prepared device risk determination worksheet
  • Documented risk mitigation protocols (if applicable)
  • Confirmed intended use statement
  • Identified all regulatory requirements that apply
  • Prepared for potential IRB questions

Ready to start? Open samd_decision_tree.html in your browser!

Questions? Check out CONTRIBUTING.md or open an issue on GitHub.