Instruction for Use (IFU) – Clear, Controlled Directions for Safe and Effective Use

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated October 2025 • Medical Devices / Food & Pharma Adjacent • Design Controls, Labeling, Risk Management • See also: DHF, DHR, Document Control, Change Control, HFE

Instruction for Use (IFU) is the controlled, user-facing part of a product’s labeling that explains what the product is, who it is for, when and how to use it, what to avoid, and how to maintain or dispose of it. For medical devices—and increasingly for complex food, cosmetic, chemical, and supplement products—the IFU translates design intent and risk controls into clear, testable instructions that enable safe, effective, and repeatable outcomes. A compliant IFU is more than prose: it is a design artifact grounded in usability evidence, risk analysis, and regulatory requirements, maintained under a formal quality system and distributed in the right version with each unit. It connects the Design History File (DHF) to the Device History Record (DHR), and it is inseparable from labeling controls, unique identification, and postmarket feedback such as complaints and adverse events.

“An IFU is not a brochure; it is a risk control that must be as engineered and verified as any physical feature.”

1) What It Is

An IFU is part of labeling that covers identification of the product and model, intended use/indications, user profile, contraindications and warnings, step-by-step operating instructions, installation or assembly if applicable, required accessories/consumables, environmental/cleaning requirements, maintenance or calibration, performance characteristics and limitations, storage/transport conditions, and disposal. It is produced as a controlled document in the quality management system, with a unique identifier, effective date, and revision history maintained under Document Control. Because instructions are a risk control, the IFU’s content and formatting are derived from risk analysis (e.g., FMEA), use-related hazard analysis, and formative/summative usability testing under HFE methods. The approved IFU is then tied to the product’s GTIN/UDI and included with each configuration via packaging and labeling controls.

2) Regulatory Anchors & Scope

For U.S. medical devices, labeling and instructions are governed by the Quality System Regulation (21 CFR 820) as part of design controls, document controls, production and process controls, and servicing. Market entry, listing, and labeling updates intersect with 21 CFR 807 (registration & listing). Unique Device Identification obligations reference 21 CFR 830 and 21 CFR 821 for UDI/traceability of certain devices. Postmarket changes to IFU content can be driven by complaints or adverse events under 21 CFR 803 and field corrections under 21 CFR 806. If IFUs are distributed electronically or maintained in electronic systems, data integrity and control expectations under 21 CFR Part 11 and, in the EU, Annex 11 can apply to the supporting records. Outside of devices, regulated sectors like food/supplements and chemicals rely on analogous principles under GMP/GFSI, allergen management, and hazard communication; while the label is primary, instructions (e.g., for safe handling or reconstitution) are still controlled and risk-derived.

3) Content, Format & Usability Evidence

Effective IFUs blend precision with clarity. Content should be written for the target user (clinician, technician, layperson), with plain language, unambiguous steps, and consistent visual design. Critical tasks—those with potential for serious harm if performed incorrectly—must be highlighted and validated through HFE evaluations. Graphical symbols and pictograms can reduce translation burden but must be explained; any reliance on color, icons, or small fonts must consider users with impairments. Warnings and contraindications come from risk analysis (e.g., misconnection hazards, incorrect assembly, incompatible accessories), and mitigations are placed adjacent to the step they mitigate. Cleaning and sterilization instructions require validated cycles and compatible agents; maintenance steps must align with actual device design and qualification realities. Where accessories/consumables are required, part numbers and GTINs should be included to avoid substitution risk. For connected or software-driven products, screenshots must match released software versions, and workflows should reflect actual HMI navigation (HMI).

4) Control, Revision & Distribution

IFUs live under Document Control with unique IDs, revision codes, and effective dates. Changes proceed via Change Control with risk assessment, redline review, and approvals from design quality, regulatory, and where relevant manufacturing/servicing. Revised IFUs often require translation updates and supply chain burn-down plans to avoid mixed-version distribution. Packaging and labeling operations must ensure the correct IFU version is picked and included for the specific SKU/configuration—this is a classic wrong-version failure mode addressed through Barcode Validation, Dual Verification, and handheld interlocks. The presence of the correct IFU is typically recorded in the DHR; in process industries, analogous evidence may appear in the eBMR at Finished Goods Release.

5) Postmarket Feedback & Continuous Improvement

IFUs evolve. Complaints, adverse events, service data, returned goods analysis, and usability observations reveal misunderstandings or gaps. Signals may trigger content changes, new warnings, or reordering of steps. Nonconformances (Deviation/NC) and investigations can lead to CAPA where the IFU revision is one element of the correction. If risk increases, a field correction or communication may be required (806), and vigilance reporting (803) may apply. Feedback cycles should be explicit in the quality system so IFU improvements are documented in the DHF and implemented into production via controlled releases.

6) Digital IFU, UDI & Traceability

Electronic distribution (eIFU) can reduce waste and improve accessibility, but it adds control obligations. Systems that store the “master IFU” and generate distributable outputs must be validated (CSV, GAMP 5) and support Part 11/Annex 11 expectations for identity, audit trails, and retention. IFU versions should be linked to specific SKUs and GTINs in the labeling master; scannable codes can route users to the correct language/version online. In networked supply chains, shipping and receipt events can reference the correct IFU artifact using EPCIS, improving downstream verification. Warehouse processes should block shipment if the IFU pick/scan-back does not match the order’s configuration and effective date. Where shelf-life or storage conditions are critical, harmonize IFU statements with Expiration / Shelf-Life Control and GDP practices.

7) Common Failure Modes & Prevention

• Wrong IFU version in the box. Prevent with scan-back on kitting, dual checks, and handheld interlocks tied to SKU/config.
• Unvalidated instructions. Fix by running formative/summative HFE studies focused on critical tasks; document in the DHF.
• Translation errors or layout drift. Control with locked templates, approved terminology glossaries, and Document Control workflows.
• Inconsistent statements across labels, CoA, and IFU. Synchronize masters under Change Control and verify during release.
• Outdated screenshots or HMI paths. Tie IFU generation to software release cycles and require screenshot reviews before go-live.
• Missing IFU in service kits. Treat service IFUs as controlled parts with pick validation and DHR evidence.

8) Metrics That Matter

• Right-version rate at kitting/pack-out; blocked shipments due to IFU mismatch (trend down).
• Usability defects (complaints, IFU-related CAPAs) per 10k units; recurrence rate after revision.
• Translation turnaround & accuracy (first-pass yield of language QA).
• Time-to-implement an IFU change from approval to all shipments (burn-down of old stock).
• Audit outcomes on labeling/IFU controls and audit-trail completeness for eIFU systems.

9) How This Fits with V5

V5 by SG Systems Global treats the IFU as a controlled, versioned asset that travels with the product configuration. In V5 QMS, IFU masters live under Document Control with routed approvals and Part 11-compliant signatures; changes are risk-assessed and executed via Change Control. In V5 WMS, kitting and pack-out enforce correct IFU inclusion with Barcode Validation against SKU/GTIN and effective date; handhelds block shipment on mismatch. GS1/GTIN and UDI identifiers bind IFU versions to labels and shipment records, and optional EPCIS events can publish IFU references downstream. In manufacturing, eBMR steps verify label and IFU picks before Finished Goods Release; in quality, complaints feed directly into CAPA and IFU redlines. Across modules, secure identities and audit trails support inspections.

10) FAQ

Q1. Is an IFU required for every device?
Complex or risk-bearing devices almost always require an IFU; very simple, intuitive products may rely on labeling alone, but the determination should be documented in the DHF.

Q2. Who approves IFU changes?
Typically design quality, regulatory, and a cross-functional team (manufacturing/servicing/complaints). Use Change Control to capture risk and rationale.

Q3. How do we prevent wrong-version IFUs?
Bind IFU revisions to SKU/GTIN, require scan-back in kitting, and block pack-out if effective-date logic fails.

Q4. When do electronic IFUs trigger Part 11?
When IFU masters and approvals are maintained electronically, or when distribution/retrieval records support compliance activities—then identity, audit trails, and retention apply.

Q5. How does human factors evidence tie in?
Use-related risk analysis identifies critical tasks; formative and summative testing demonstrate that users can follow the IFU correctly under realistic conditions.

Q6. What belongs in the DHR for IFUs?
Evidence that the correct IFU revision was included (pick/scan logs), plus any rework or language-specific inclusions for the shipped lot/configuration.

Q7. How do complaints affect IFUs?
Complaint trending can reveal confusion or misuse; if IFU changes mitigate risk, route through CAPA and Change Control, and update translations and packaging picks.

Q8. Do IFUs interact with shelf-life statements?
Yes—storage and in-use stability guidance must be consistent with Expiration / Shelf-Life Control and distribution controls under GDP.

Related Reading
• Design & Risk: DHF | HFE | FMEA
• Production & Records: DHR | eBMR | Finished Goods Release
• Labeling & Traceability: GS1 / GTIN | Barcode Validation | EPCIS
• Quality System & Data: Document Control | Change Control | CAPA | Audit Trail (GxP) | 21 CFR Part 11 | Annex 11
• Regulations & Postmarket: 21 CFR 820 | 21 CFR 807 | 21 CFR 821 | 21 CFR 830 | 21 CFR 803 | 21 CFR 806