# Four-criteria checklist (FDA CDS guidance, January 2026)

Intended-use statement: `docs/intended-use.md`.
Guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software

Criterion 1: no images, IVD signals, or signal-acquisition patterns.
Criterion 2: displays or analyzes medical information.
Criterion 3: recommendations, not directives; no patient-specific scores.
Criterion 4: the user can independently review the basis.

| Tool | C1 | C2 | C3 | C4 | Notes |
|---|---|---|---|---|---|
| `deidentify_text` | text in, text out | administrative redaction, not CDS | no recommendation | residual-risk note plus per-category report | Safe Harbor assistant, not a certification |
| `sbar_handover_draft` | text | reorganizes clinician notes | scaffold and gap list, no plan of care | cites IHI SBAR / NEJM I-PASS | draft banner required |
| `discharge_summary_draft` | text | same | same | cites Joint Commission components and Kripalani 2007 | pending-results field is required |
| `progress_note_draft` | text | reorganizes clinician notes into SOAP or APSO | scaffold and gap list, no code level | cites Weed, NEJM 1968; assessment guidance names the AMA E/M MDM elements without scoring them | draft banner required |
| `admission_history_physical_draft` | text | same for admission documentation | same | cites Joint Commission 24-hour H&P expectation and the AMA E/M hospital-care field set | allergies and reconciliation must be explicit |
| `patient_instructions_draft` | text | readability of clinician-authored instructions | score and jargon list, clinician approves | cites AHRQ health-literacy target | no patient-facing send |
| `note_completeness_check` | text | documentation standards | pass/gap, no treatment | cites the checklist URL in every result | heuristic scan, labeled as such |
| `drug_label_lookup` | text (drug name) | FDA-approved labeling | verbatim sections, no adjudication | SPL set id, effective date, DailyMed URL, retrieval date | explicitly not an interaction checker |
| `patient_education_lookup` | text (term or code) | government patient education | displays MedlinePlus pages | code resolution, URL, retrieval date | NLM terms: no PHI in the request |
| `pubmed_evidence_search` | text (query) | peer-reviewed citations | citations, not a synthesis that hides sources | PMID, URL, exact query, retrieval date | empty result is reported as empty |
| `trial_search` | text (condition term) | registry records from ClinicalTrials.gov | study listings, eligibility left to the source page | NCT number, status, sponsor, URL, retrieval date | no eligibility judgment |

Time-critical use is out of scope for all eleven. The persona declines
emergency framings.

No tool in this release relies on FDA's 2026 enforcement-discretion clause
for software whose single output is the only clinically appropriate option.
The August 2026 CDRH discussion paper on generative AI devices places
informational, non-directive outputs at the lowest risk tier; every tool here
stays on that tier by construction: drafts are never directives.