FDA Regulatory Determination
Software as a Medical Device (SaMD) Analysis & Enforcement Discretion Basis
1. Purpose of This Document
This document records OncoCompass's internal analysis of whether its software constitutes a medical device under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the 21st Century Cures Act, and whether FDA enforcement discretion applies to its current feature set. This document is intended for internal use, legal review, and regulatory disclosure purposes.
This determination should be reviewed annually and upon any material change to the product's features, intended use, or applicable FDA guidance.
2. Product Description
OncoCompass is a web-based patient navigation and support platform for oncology patients and caregivers. The application provides the following core functions:
- Symptom triage guidance — Helps patients determine the urgency of reporting symptoms to their oncology team (e.g., "call today" vs. "monitor at home"). Does not provide diagnosis.
- Care plan organization — Allows patients to document their cancer type, stage, treatment regimen, and treatment timeline for personal reference.
- Symptom and vitals diary — Enables daily self-logging of symptoms and vitals (temperature, blood pressure, heart rate, O₂ saturation, weight) for personal tracking and sharing with care team.
- Visit preparation assistance — Generates suggested questions for upcoming oncology appointments based on the patient's care plan and recent symptom logs.
- Clinical trial finder — Queries the ClinicalTrials.gov API (public NIH database) to surface recruiting trials relevant to the patient's diagnosis.
- Patient education — Provides general oncology educational content about treatment modalities (chemotherapy, immunotherapy, radiation, etc.).
- AI-powered Q&A — Allows patients to ask plain-language questions about their treatment and care; responses are educational and explicitly disclaim clinical advice.
3. Applicable Regulatory Framework
Key FDA Guidance Documents
Under the FD&C Act as amended by the 21st Century Cures Act (21 U.S.C. § 321(h)), certain software functions are explicitly excluded from the definition of a "device," and others fall within categories where FDA exercises enforcement discretion.
4. SaMD Risk Classification Analysis
The International Medical Device Regulators Forum (IMDRF) SaMD framework classifies software based on: (1) the significance of information provided and (2) the healthcare situation. This analysis applies that framework to OncoCompass.
| Feature | Information Significance | Healthcare Situation | IMDRF Category | FDA Position |
|---|---|---|---|---|
| Symptom triage / urgency guidance | Inform clinical management | Non-serious | Category II | Enforcement discretion |
| Care plan documentation | Administrative | N/A | Excluded | Not a device |
| Symptom & vitals diary | Inform clinical management | Non-serious | Category I–II | Enforcement discretion |
| Visit prep question generator | Administrative / patient communication | N/A | Excluded | Not a device |
| Clinical trial search | Inform patient decision | Non-serious | Category I | Enforcement discretion |
| Patient education content | General wellness | N/A | Excluded | Not a device |
| AI Q&A (educational) | Inform patient decision | Non-serious | Category I | Enforcement discretion |
5. Basis for Enforcement Discretion
FDA's September 2022 guidance on "Policy for Device Software Functions and Mobile Medical Applications" identifies categories of software where FDA intends to exercise enforcement discretion — meaning FDA does not intend to enforce requirements under the FD&C Act, even if the software technically meets the definition of a device.
OncoCompass qualifies for enforcement discretion on the following independent grounds:
5.1 No Diagnosis or Treatment Decision
OncoCompass explicitly and by design does not provide diagnosis, prognosis, or treatment recommendations. Every output is framed as navigation guidance — directing patients toward or away from clinical contact. The application cannot and does not replace a licensed clinician's judgment. This is the foundational distinction under FDA's guidance between clinical decision support that is regulated and that which is not.
Reference: FDA CDS Guidance (Sept. 2022), Section IV.B — "Non-Device CDS" criteria, including that the software "displays, analyzes, or prints medical information about a patient or other medical information" for the purpose of supporting or providing recommendations to a clinician vs. to a patient for self-management.
5.2 General Wellness — Low Risk
Several OncoCompass features (symptom diary, vitals logging, educational content, visit preparation) fall within FDA's "general wellness" category under 21 CFR Part 880. The FDA's guidance on General Wellness Policy (July 2016) states that software intended to "promote, track, and/or encourage general wellness activities" and that poses low risk to users is not subject to regulatory oversight.
5.3 Administrative Support Functions
The care plan documentation, visit prep generator, and oncology message generator are administrative support functions. Under 21 U.S.C. § 321(h)(1)(B), software intended for "administrative support of a health care facility" is excluded from the device definition. While OncoCompass is not a facility, these functions are directly analogous to administrative patient communication tools.
5.4 Patient-Directed vs. Clinician-Directed
FDA's enforcement discretion framework distinguishes between software that presents information to a clinician for direct clinical decision-making (regulated) and software that helps patients understand their health and communicate with their care team (lower risk). All OncoCompass outputs are directed at patients and caregivers, not clinicians making treatment decisions. The explicit instructions within the app always direct users to consult their oncology team.
5.5 21st Century Cures Act Exclusions
The 21st Century Cures Act (2016) amended the FD&C Act to exclude from the device definition:
- Software for administrative support of healthcare facilities
- Software that helps patients self-manage a disease or condition without providing specific treatment or diagnostic recommendations
- Software that communicates electronic health information
OncoCompass's patient diary, care plan, and communication features fall within these statutory exclusions.
6. Features That Require Ongoing Monitoring
⚠ Watch list — regulatory status may change with product evolution
- Symptom urgency triage: If the algorithm evolves to suggest specific diagnoses (e.g., "this sounds like neutropenic fever") rather than urgency navigation, it may cross into regulated CDS territory. Current implementation uses urgency levels only (emergency / urgent / soon / monitor) without naming conditions.
- AI Q&A: If AI responses begin providing specific treatment recommendations or substituting for clinical advice, regulatory status should be re-evaluated. Current implementation includes explicit disclaimers and is framed as educational only.
- Vitals monitoring with alert thresholds:The diary includes threshold warnings (e.g., temp ≥ 100.4°F, O₂ < 94%). If this evolves into automated real-time monitoring with clinical alert escalation, it may approach regulated device territory.
7. Product Controls Maintaining Exempt Status
The following controls are implemented and must be maintained to preserve enforcement discretion status:
No diagnosis language in any output
Outputs framed as urgency levels and navigation guidance only
Explicit care team referral in all clinical outputs
'Always consult your oncology team' present on all assessment and AI results
Medical disclaimer on all pages
Displayed at login, results, education, and footer
No autonomous treatment recommendation
All suggestions are directional (seek care / monitor) not prescriptive
No direct clinician interface
Tool is patient-facing only; outputs are informational for patient use
Emergency escalation always included
'Call 911' and ER guidance included in all urgent/emergency outputs
Legal counsel review of this document
Pending — should be completed before institutional or App Store launch
Annual regulatory review
Scheduled for June 4, 2027
8. Conclusion
Determination: FDA Enforcement Discretion Applicable
Based on the analysis above, OncoCompass in its current form is either excluded from the definition of a medical device under the 21st Century Cures Act, or falls within categories for which FDA has stated it does not intend to enforce device requirements. The product is a patient navigation, education, and communication support tool. It does not diagnose, prescribe, or substitute for clinical care.
This determination is based on the product as described in Section 2 and the controls described in Section 7. Any material change to the product's intended use, user population, or clinical outputs should trigger re-evaluation of this determination.
9. Document History & Signatures
| Version | Date | Author | Change | Legal Review |
|---|---|---|---|---|
| v1.0 | June 4, 2026 | OncoCompass Team | Initial determination | Pending |
Attestation: This document represents OncoCompass's good-faith regulatory analysis based on FDA guidance current as of the date above. This is an internal working document and does not constitute legal advice. OncoCompass will seek review from qualified healthcare regulatory counsel prior to institutional sales, App Store submission, or any partnership with a HIPAA Covered Entity.