Intended Use vs Indications for Use
Understand (and document) the regulatory difference between Intended Use and Indications for Use. This practical guide includes definitions, checklists, traceability tools, and examples you can lift into your QMS and submissions for medical devices including SaMD.
What These Terms Mean (and Why They Matter)
Intended Use is the manufacturer’s formal statement of the device’s purpose, users, use environment, and general medical function—owned by the manufacturer and reflected in labeling/IFU.
Indications for Use are the specific clinical conditions, populations, or settings for which the device has been shown to be safe and effective. They are evidence-based and guide when/how clinicians should use the device.
At a Glance — Key Differences
| Aspect | Intended Use | Indications for Use |
|---|---|---|
| Ownership | Manufacturer defines | Defined/cleared with the regulator |
| Scope | General medical purpose and users | Specific diseases, conditions, populations, settings |
| Evidence Basis | Design inputs, risk mgmt, usability | Clinical evidence showing safety/performance |
| Regulatory Impact | Drives classification & conformity route | Drives labeling claims & approval/clearance |
| Change Control | QMS design change; may trigger submission | Usually triggers submission/notification |
How to Draft an Audit-Ready Intended Use
- State the medical purpose (diagnosis, monitoring, treatment, mitigation, prediction, support).
- Define intended users (HCP specialty, trained lay users) and use environment (hospital, home).
- Limitations & boundaries (adjunctive use; does not replace clinician judgment).
- Population (adult/pediatric, disease stage, contraindications if known).
- Device mode of action (what it does, not how it’s built).
- Consistency check across IFU, risk file, clinical plan, and marketing content.
How to Craft Evidence-Backed Indications for Use
- List the clinical conditions or use cases your evidence supports (be precise).
- Define population & setting (age ranges, severity, inpatient/outpatient, home use).
- Specify triggers/parameters (e.g., symptomatic bradycardia; HbA1c thresholds; imaging modality).
- Tie to endpoints measured (diagnostic accuracy, sensitivity/specificity, usability, safety outcomes).
- Avoid over-reach—do not exceed your data; add “not intended for” if needed.
Traceability — Keep Claims, Evidence, and Labels in Lockstep
| Element | Where It Lives | Primary Owner | Audit-Ready Proof | Common Pitfalls |
|---|---|---|---|---|
| Intended Use | IFU, labeling master, design inputs | RA with PRRC | Signed labeling master; consistency across docs | Vague purpose; claims creep in marketing |
| Indications for Use | IFU front matter; submission summary | RA/Clinical | Evidence summary matching exact wording | Over-claim beyond datasets or populations |
| Claims | IFU, website, brochures, app store text | Marketing with RA review | Claim register with evidence links | Unsupported superlatives; off-label in ads |
| Evidence | CER/performance eval; V&V; usability | Clinical/QA | Traceability matrix to endpoints | Endpoints don’t match indications |
Examples
Pacemaker (Implantable)
Intended Use: To regulate heart rhythm in patients requiring cardiac pacing, used by qualified cardiologists in hospital settings.
Indications for Use: Symptomatic bradycardia; sinus node dysfunction with or without symptomatic bradycardia; high-grade AV block with or without symptomatic bradycardia.
SaMD — Glucose Data Decision Support
Intended Use: To analyze interstitial glucose and lifestyle inputs and provide decision support to adults with type 2 diabetes for therapy optimization, under healthcare professional supervision.
Indications for Use: Adjunctive use in adults with type 2 diabetes for assessment of glycemic trends and identification of hypoglycemia risk; not intended for standalone diagnosis or pediatric use.
Orthopedic Planning Software
Intended Use: To assist surgeons in preoperative planning of joint replacement by measuring anatomical parameters from radiographic images.
Indications for Use: Quantitative measurement of osteoarthritic knee alignment parameters on AP/Lat radiographs in adults to inform implant sizing and alignment selection.
Operationalize in Your QMS
- Design Inputs: Capture Intended Use early; align user needs and hazards accordingly.
- Clinical Plan: Build studies/endpoints that directly support desired Indications.
- Labeling SOP: RA + PRRC approve wording; maintain a master labeling file.
- Marketing Review: Route all public claims through RA/PRRC claim review.
- Change Control: Treat wording changes as design changes; assess submission impact.
RACI — Who Does What
| Activity | R | A | C | I |
|---|---|---|---|---|
| Draft Intended Use | RA | PRRC | Clinical, Product | QA, Marketing |
| Draft Indications for Use | Clinical | RA | PRRC, Medical | QA, Product |
| Evidence Mapping | Clinical | QA | RA | PRRC |
| Labeling Approval | RA | PRRC | QA | Marketing |
| Change Control Assessment | RA | QA | PRRC, Clinical | Product |
Common Pitfalls (and How to Avoid Them)
- Blurry language: Use clinical terms, define users/settings, avoid marketing adjectives.
- Evidence mismatch: If you didn’t study it, don’t claim it; adjust indications or add data.
- Claims creep: Keep websites, brochures, and app store text aligned with approved wording.
- Population drift: Pediatric vs adult, comorbidities, and contraindications must be explicit.
- Change unmanaged: Even minor wording shifts can change risk or submission status—run through change control.
Quick Checklists
Pre-Submission Wording Checks
- Intended Use and Indications are consistent across IFU, submission, and marketing.
- Endpoints in studies map directly to Indications wording.
- Risk file reflects the users, settings, and populations named.
- Usability and cybersecurity testing align with the environments claimed.
- PRRC sign-off captured in labeling approval record.
Post-Release Surveillance Alignment
- Capture off-label usage signals in PMS; feed into risk management and labeling review.
- Trend complaints by indicated condition/population; reassess claims if patterns emerge.
FAQ
Can Intended Use and Indications be identical?
They should be consistent, but Indications are typically more specific and evidence-anchored. A broader Intended Use with precise Indications is common.
Can we broaden Indications later?
Yes—if supported by new evidence and processed via change control and, where required, regulatory submission.
Who has final say on wording?
RA/PRRC approve labeling. Clinical ensures evidence fit. QA verifies process and records.
Bottom Line
Draft the Intended Use to define purpose and boundaries. Build clinical and V&V plans that prove the Indications for Use. Keep wording synchronized across labeling, submissions, and marketing, with PRRC oversight and structured change control. That’s how you stay compliant and audit-ready while enabling safe, effective adoption.
Disclaimer: This material is for general informational purposes to support internal documentation. It is not legal advice and does not replace applicable laws, standards, guidance, or regulator/Notified Body decisions.
Legal References — Intended Use vs. Indications for Use
What this page clarifies: In the EU, legislation uses “intended purpose” (MDR/IVDR). In the US, FDA uses “intended use” and requires a formal “Indications for Use” statement in submissions. Across both systems, wording must align consistently in labeling/IFU, risk files, clinical or performance evidence, and marketing materials.
European Union — Medical Devices Regulation (MDR) 2017/745
- Article 2 — Definitions (includes intended purpose).
- Annex I — General Safety and Performance Requirements; Information supplied by the manufacturer (labeling, IFU).
- Annex II / Annex III — Technical documentation and technical documentation on post-market surveillance.
- Annex VIII — Classification rules (including Rule 11 for software, where relevant).
- Annex XIV — Clinical evaluation (framework for evidence supporting claims/indications).
- Article 10(9) — Quality management system obligations (consistency of labeling, claims, evidence).
- Article 15 — Person Responsible for Regulatory Compliance (PRRC) oversight of documentation and compliance.
European Union — In Vitro Diagnostic Regulation (IVDR) 2017/746
- Article 2 — Definitions (includes intended purpose for IVDs).
- Annex I — General Safety and Performance Requirements; Information supplied by the manufacturer.
- Annex II / Annex III — Technical documentation and PMS technical documentation.
- Annex XIII — Performance evaluation (evidence alignment for indications/claims).
- Article 15 — PRRC obligations for IVD manufacturers and authorized representatives.
United States — FDA Regulations (Title 21, Code of Federal Regulations)
- 21 CFR 801.4 — Definition and interpretation of intended uses (labeling context).
- 21 CFR 807.92(a)(5) — 510(k) Summary content (includes Indications for Use statement).
- 21 CFR 814.20 — PMA application content (requires Indications for Use and supporting data).
- 21 CFR 820 — Quality System requirements (design controls, labeling controls, documentation traceability).
Compliance note: EU legislation uses intended purpose; US law uses intended use and a specific Indications for Use statement. Maintain consistent wording and traceability across IFU/labeling, risk management files, clinical or performance evidence, PMS/PMCF/IVD PE, and marketing materials.
This reference is provided for general informational purposes to support internal documentation. It is not legal advice and does not replace applicable laws, guidance, or decisions by regulators or Notified Bodies.
