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<!DOCTYPE html>
<html lang="en">
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<title>AI Medical Device Regulatory Classification Tool - Tech in HSR</title>
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<div class="header-content">
<h1>AI Medical Device Regulatory Classification Tool</h1>
<div class="subtitle"><strong>Tech in HSR</strong></div>
<p>Use this decision tree to determine which regulatory frameworks apply to your AI tool. Click on each question to explore the classification pathway.</p>
<div class="key-principle">
<p><strong>Key Principle:</strong> Intended use determines regulatory classification. Start by clearly defining how the AI tool will be used and by whom, then follow the decision tree to identify applicable oversight requirements.</p>
</div>
</div>
</div>
<div class="main-content">
<h2 class="section-title">Decision Tree</h2>
<div id="tree-root"></div>
</div>
<div class="definitions">
<h2 class="section-title">Key Definitions</h2>
<div class="definition-item purple">
<strong>Medical Device (FDA):</strong>
<p>Instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease, or intended to affect structure or function of the body.</p>
</div>
<div class="definition-item green">
<strong>Research (Common Rule):</strong>
<p>A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102(l)).</p>
</div>
<div class="definition-item orange">
<strong>Clinical Investigation (FDA):</strong>
<p>Any experiment that involves a test article and one or more human subjects, and is subject to requirements for submission to FDA (21 CFR 50.3(c)).</p>
</div>
<div class="definition-item blue">
<strong>Quality Improvement:</strong>
<p>Activities designed to improve local processes and outcomes, not designed to contribute to generalizable knowledge. However, if the activity produces a medical device or will be published/shared, it may require regulatory oversight.</p>
</div>
</div>
<div class="caveats">
<h3>⚠️ Important Caveats</h3>
<ul>
<li><strong>Labeling matters less than function:</strong> Calling something QI or operations does not bypass FDA requirements if the tool functions as a medical device.</li>
<li><strong>HIPAA applies broadly:</strong> Even if not research, use of PHI may require authorization or fall under specific HIPAA provisions.</li>
<li><strong>Multiple frameworks can apply:</strong> FDA + Common Rule dual oversight is common for federally funded device studies.</li>
<li><strong>Commercialization changes classification:</strong> Internal QI that becomes a commercial product triggers FDA oversight retroactively.</li>
<li><strong>IRB purview varies:</strong> Some IRBs apply Common Rule standards to all research regardless of funding source.</li>
</ul>
</div>
<div class="footer">
<p><strong>Tech in HSR</strong> | AI Medical Device Regulatory Classification Tool</p>
<p>For questions or feedback, consult with your institutional IRB and regulatory affairs team.</p>
</div>
</div>
<script>
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id: 'root',
q: 'What is the intended use of the AI tool?',
c: [
{
id: 'cd',
q: 'To inform clinical decision-making (diagnosis, treatment, prevention, mitigation)',
c: [{
id: 'fdc',
q: 'Does this meet FDA definition of medical device?',
c: [{
id: 'fy',
q: 'YES - Intended for diagnosis, treatment, prevention, or mitigation of disease',
c: [{
id: 'ds',
q: 'What is the device status?',
c: [{
id: 'inv',
q: 'Investigational/Unvalidated',
c: [{
id: 'ff',
q: 'Is this federally funded?',
c: [{
id: 'do',
q: 'YES - Federally funded',
o: 'DUAL OVERSIGHT: FDA regulations (21 CFR 50, 56, 812 IDE) + Common Rule (45 CFR 46). More restrictive regulation applies. Requires: IRB review, informed consent (or waiver with justification), IDE submission if significant risk device, HIPAA authorization or waiver.'
}, {
id: 'fo',
q: 'NO - Not federally funded',
o: 'FDA OVERSIGHT: 21 CFR 50, 56, 812 (IDE regulations). Requires: IRB review, informed consent, IDE submission if significant risk device, HIPAA authorization (research not covered under TPO).'
}]
}]
}, {
id: 'clr',
q: 'FDA-cleared/approved device',
c: [{
id: 'ru',
q: 'Being used in research study?',
c: [{
id: 'cry',
q: 'YES - Part of research protocol',
o: 'RESEARCH OVERSIGHT: Common Rule applies if federally funded. IRB review required. Device itself may not need IDE but study requires IRB approval. Consider: Is device being used per label? Off-label use in research may have additional requirements.'
}, {
id: 'crn',
q: 'NO - Standard clinical use',
o: 'STANDARD OF CARE: No additional research oversight if used per FDA-cleared indication. Subject to institutional policies and standard of care requirements. Not research under Common Rule.'
}]
}]
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}, {
id: 'fn',
q: 'NO - Does not meet FDA medical device definition',
c: [{
id: 'gen',
q: 'Is this designed to contribute to generalizable knowledge?',
c: [{
id: 'gy',
q: 'YES - Research design',
o: 'RESEARCH (Common Rule): If federally funded, 45 CFR 46 applies. Requires IRB review, determination of human subjects research, informed consent or waiver. HIPAA authorization or waiver required for PHI use.'
}, {
id: 'gn',
q: 'NO - Internal QI/operations',
o: 'QUALITY IMPROVEMENT: May not be research under Common Rule. Subject to institutional QI oversight. However: verify intended use does not evolve into medical device; ensure not commercializing tool; HIPAA may still apply if PHI used; consider if results will be published (converts to research).'
}]
}]
}]
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}, {
id: 'rs',
q: 'To support research activities (not clinical care)',
c: [{
id: 'rt',
q: 'AI is a tool within research, not the subject being studied',
c: [{
id: 'rf',
q: 'Is the research federally funded?',
c: [{
id: 'rfy',
q: 'YES',
o: 'COMMON RULE RESEARCH: 45 CFR 46 applies. IRB review of overall research protocol required. AI tool should be described in protocol. Consider: Does AI tool itself need validation? Is AI output part of research data? HIPAA authorization needed for PHI.'
}, {
id: 'rfn',
q: 'NO - Not federally funded',
o: 'INSTITUTIONAL RESEARCH OVERSIGHT: Common Rule may not apply, but institutional IRB may review under institutional policy. Many IRBs apply Common Rule standards to all research. Describe AI tool in protocol. HIPAA applies if using PHI.'
}]
}]
}]
}, {
id: 'op',
q: 'To improve operational workflows or quality metrics (not patient care decisions)',
c: [{
id: 'ou',
q: 'Administrative/operational use only',
o: 'OPERATIONS/QI: Likely not research and not FDA-regulated medical device. Subject to institutional policies. Consider: Will tool eventually inform clinical decisions? (converts to medical device). Will results be published? (converts to research). Does it use PHI? (HIPAA applies).'
}]
}, {
id: 'reg',
q: 'To generate data for regulatory submission or commercialization',
c: [{
id: 'com',
q: 'Commercial device development',
o: 'FDA + COMMERCIAL: FDA oversight applies (likely IDE required). If federally funded, Common Rule also applies. Critical considerations: HIPAA authorization required if PHI from covered entities (TPO exception does not apply to research/commercial development). Cannot rely on QI label to bypass FDA requirements. Design History File (DHF) requirements apply. Clinical evaluation needed per FDA guidance.'
}]
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