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EPPA Non-Device Disclaimer

Mandatory surface — do not ship without it

Every UI surface, every export, every marketing page and every README in the EPPA product family must carry the disclaimer below in the surface's language, in a position that is visible at the moment of use of any clinical output. Omitting this disclaimer exposes LABIS UCA to: enforcement action by the FDA (in the US) for marketing an unapproved medical device under 21 U.S.C. § 331 and 21 CFR 807; enforcement by EU national competent authorities under EU MDR Art. 7 (claims) and Art. 10 (general obligations of manufacturers); civil liability for patient harm; and reputational damage to LABIS UCA and Universidad Católica Argentina.

1. Authoritative disclaimer wording

The four locale variants below are the only approved wordings. Any variation requires sign-off as described in section 6.

1.1 Spanish — es (default, source-of-truth language)

Solo para uso en investigación. No es un dispositivo médico.

EPPA no está autorizado, registrado ni habilitado como producto médico por ninguna autoridad regulatoria (ANMAT, AEMPS, BfArM, FDA, ANVISA u otras). Sus resultados son orientativos y deben ser interpretados exclusivamente por un kinesiólogo, fisioterapeuta o médico debidamente matriculado. EPPA no debe utilizarse como base única o principal para diagnosticar enfermedades, indicar tratamientos, certificar aptitudes, ni para ninguna decisión clínica con consecuencias legales, laborales o asistenciales. Su utilización fuera de un protocolo de investigación aprobado queda bajo la exclusiva responsabilidad del usuario.

1.2 English — en

Research use only. Not a medical device.

EPPA is not approved, registered or cleared as a medical device by any regulatory authority (FDA, EMA / national competent authorities under EU MDR, MHRA, Health Canada, ANMAT, ANVISA, or others). Its outputs are informational and must be interpreted exclusively by a duly registered kinesiologist, physiotherapist or physician. EPPA must not be used as the sole or primary basis for diagnosing any condition, prescribing treatment, certifying fitness, or making any clinical, legal, occupational or insurance decision. Use outside an approved research protocol is at the user's sole responsibility.

1.3 German — de

Nur für Forschungszwecke. Kein Medizinprodukt.

EPPA ist von keiner Aufsichtsbehörde (BfArM, EMA / nationalen zuständigen Behörden im Rahmen der EU-MDR, FDA, MHRA, ANMAT, ANVISA u.a.) als Medizinprodukt zugelassen, registriert oder freigegeben. Die Ergebnisse sind informativ und dürfen ausschließlich von ordnungsgemäß registrierten Physiotherapeut:innen, Kinesiolog:innen oder Ärzt:innen interpretiert werden. EPPA darf nicht als alleinige oder primäre Grundlage für die Diagnose von Erkrankungen, die Verordnung von Behandlungen, die Bescheinigung der Tauglichkeit oder für klinische, rechtliche, berufliche oder versicherungsrelevante Entscheidungen verwendet werden. Die Nutzung außerhalb eines genehmigten Forschungsprotokolls erfolgt auf alleinige Verantwortung der Nutzerin oder des Nutzers.

1.4 Portuguese (Brazilian) — pt-BR

Uso exclusivamente em pesquisa. Não é um dispositivo médico.

O EPPA não é aprovado, registrado nem habilitado como dispositivo médico por nenhuma autoridade regulatória (ANVISA, FDA, EMA / autoridades nacionais competentes no âmbito do MDR-UE, ANMAT, MHRA, entre outras). Seus resultados são informativos e devem ser interpretados exclusivamente por fisioterapeuta, cinesiologista ou médico devidamente registrado. O EPPA não deve ser utilizado como base única ou principal para diagnosticar condições, prescrever tratamentos, atestar aptidões ou para qualquer decisão clínica, jurídica, ocupacional ou previdenciária. O uso fora de um protocolo de pesquisa aprovado é de responsabilidade exclusiva do usuário.

2. Short-form variants

In contexts where the full text does not fit (e.g. mobile footers, page chrome, CSV header), the following short forms are approved. They must link to or accompany the full text in section 1.

Locale Short form
es "Solo para uso en investigación — No es un dispositivo médico."
en "Research use only — Not a medical device."
de "Nur für Forschungszwecke — Kein Medizinprodukt."
pt-BR "Uso exclusivamente em pesquisa — Não é um dispositivo médico."

3. Where the disclaimer must appear

3.1 EPPA web/PWA application surfaces

Surface Variant Position Implementation notes
Login screen Full (section 1) Footer of the login card, persistent Must be visible without scrolling at 1366×768 and at iPhone-SE viewport (375×667).
Application header Short (section 2) Persistent ribbon directly below the app header bar Use a data-testid="non-device-banner" element. Not dismissable.
Every analysis page (anterior, posterior, lateral-derecha, lateral-izquierda) Short (section 2) Persistent footer of the analysis result panel Must remain visible when results are scrolled.
Marker-capture page Short (section 2) Persistent footer Same as above.
CSV export (header row) Full (section 1, single-cell first row) Row 1 of the CSV file Quote the entire text in a single CSV cell. Subsequent header row is row 2.
PDF export (report header) Full (section 1) First page header, repeated on every page footer (short form) Use the locale of the user who exported the report.
Settings / About page Full (section 1) Body of the page, plus a "Last updated" date This is also where the version, build hash and regulatory contact appear.
Error pages (4xx / 5xx) Short (section 2) Footer Even on error pages — the disclaimer must accompany any branded surface.
Empty states (e.g. "no analyses yet") Short (section 2) Footer of the empty-state panel

3.2 Marketing site, documentation portal and source repository

Surface Variant Position
eppa.crisolabs.com — every page footer Short (section 2) Site-wide footer in MkDocs Material extra.copyright
eppa.crisolabs.com — landing / "Producto" page hero area Full (section 1) Below the hero illustration, above the fold on desktop
eppa.crisolabs.com — Clinical manual landing page Full (section 1) Top of the page, before any clinical instruction
eppa.crisolabs.com — Compliance section Cross-link to this document Every compliance page links here in its front matter
GitHub README (root + EPPA front README) Full English (section 1.2) + link to this doc Top of the README, immediately after the project title and badges
README badges "research-use-only" badge Same line as build/version badges
package.json description field Short English (section 2.2) Appended to product description
pyproject.toml description field Short English (section 2.2) Appended to product description
API responses from the FastAPI backend Short English (section 2.2) Header X-EPPA-Status: research-use-only; not-a-medical-device on every response

3.3 Patient-facing materials

Patient-facing materials are produced by the deploying clinic, not by LABIS UCA. The clinic is responsible for inserting the locally-applicable disclaimer in patient information sheets and consent forms. A template is provided at compliance/templates/patient-information-sheet.md (planned).

4. When this disclaimer may be removed

The disclaimer may be removed in a specific jurisdiction only after all of the following have been satisfied for that jurisdiction:

  1. EPPA has been issued a valid certificate / clearance / registration by the competent regulatory authority:
    • EU — CE marking under Regulation (EU) 2017/745, issued by a notified body for the appropriate class (Class IIa minimum, see 00-overview.md §2), with EUDAMED entry per Art. 33.
    • US — FDA 510(k) clearance, De Novo authorisation, or PMA approval under 21 CFR Parts 807 / 814, listed on the FDA establishment registry under 21 CFR 807.
    • Argentina — ANMAT registration under Disp. 2318/2002 and the applicable software-specific disposition.
    • Brazil — ANVISA registration under RDC 751/2022.
    • Germany — additionally registered under the German MPDG with the appropriate UDI in the BfArM register.
  2. A Declaration of Conformity (EU) or equivalent has been signed by the manufacturer.
  3. The intended-use statement in 01-intended-use-statement.md has been re-issued as a device IFU and is the authoritative claim document.
  4. The ISO 13485 QMS is operational and certified.
  5. The ISO 14971 risk file is closed for the marketed configuration.
  6. Post-market surveillance (EU MDR Art. 83) and vigilance (Art. 87 to 92) are in place and operating, including reporting channels and a PMS plan.
  7. Removal is approved in writing by Head of Regulatory, Head of Quality, Head of Clinical and the LABIS UCA institutional sponsor.

Removal in one jurisdiction does not authorise removal in another. The short-form disclaimer must continue to appear in any locale or surface that serves users in a not-yet-authorised jurisdiction. In practice this means that, even after first CE marking, the disclaimer continues to appear in locale-en / locale-pt-BR / locale-es-AR until FDA / ANVISA / ANMAT authorisations also land.

5. Reference — FDA enforcement actions for omitted disclaimers

The FDA has consistently treated software marketed for clinical interpretation without an appropriate disclaimer or premarket authorisation as a violation of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 331. Specific examples the regulatory team is expected to source and cite once verified:

Citations pending regulatory-team verification

The following two cases are commonly cited in SaMD compliance practice. The URLs to the specific warning letters on FDA.gov must be verified by the regulatory lead before this document is approved. They are listed here as known starting points, not as verified citations.

  1. TBD — FDA Warning Letter to a vendor of mobile-camera-based diagnostic software whose marketing claims (and absence of disclaimer) caused the product to meet the device definition under 21 U.S.C. § 321(h). The vendor was directed to either cease marketing or seek premarket clearance under 21 CFR 807.81. URL: TBD — regulatory team to source from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters.
  2. TBD — FDA Warning Letter to a developer of image-analysis software marketed for clinical use, cited for marketing an unapproved Class II device and for inadequate labelling under 21 CFR 801. URL: TBD — same source as above.

Additionally, FDA guidance on labelling and intended-use determination is authoritative:

European-equivalent enforcement context:

  • EU MDR Art. 7 ("Claims") prohibits text, names, trademarks, pictures and figurative or other signs that may mislead the user as to the device's intended purpose, safety and performance. Marketing a non-device as if it were a device, or vice-versa, falls under Art. 7.
  • MDCG 2019-11 governs the borderline between software-not-a-device and SaMD; any change in claims that crosses the line triggers Art. 10 manufacturer obligations.

6. Change control for the disclaimer text

The disclaimer wording in section 1 is regulatory load-bearing. Any change requires:

  1. New version of this document (semver: MAJOR for substantive wording changes; MINOR for editorial; PATCH for typographical).
  2. Sign-off by Head of Regulatory, Head of Clinical and Head of Quality.
  3. Translation re-review by a qualified human translator for the affected locales — machine translation alone is not sufficient for the legal text of the disclaimer.
  4. Roll-out plan: all surfaces in section 3 updated in the same release; no partial roll-out is permitted (i.e. you may not ship the new app build with the old marketing page wording or vice versa).
  5. Communication to all credentialed users.
  6. Update to the GDPR DPIA (30-gdpr-dpia.md) if the change affects how the data subject is informed (Art. 13 / 14).

7. Implementation checklist

Before any EPPA release ships, every item below must be ticked off:

  • [ ] Login screen footer — full disclaimer, correct locale.
  • [ ] Persistent header ribbon — short disclaimer, correct locale, present on every authenticated page.
  • [ ] All four analysis pages — short disclaimer in result panel footer.
  • [ ] Marker-capture page — short disclaimer in footer.
  • [ ] CSV export — row 1 contains full disclaimer.
  • [ ] PDF export — header on page 1, footer on subsequent pages.
  • [ ] About / Settings page — full disclaimer plus version + regulatory contact.
  • [ ] API responses — X-EPPA-Status header on every response from FastAPI.
  • [ ] MkDocs site footer — short disclaimer in extra.copyright.
  • [ ] README — full English disclaimer in the introductory section.
  • [ ] README badge — "research-use-only" badge present.
  • [ ] package.json and pyproject.toml — short disclaimer appended to description.
  • [ ] Locale parity — all four locales (es, en, de, pt-BR) carry the disclaimer in the matching language.
  • [ ] Playwright test — playwright/e2e/non-device-disclaimer.spec.ts (planned) asserts presence on every public page.
  • [ ] MkDocs link check — no broken link to this document from any other compliance doc.

References