For a medical device, the manual itself can hold up market entry. In regulatory terms the user manual is the IFU (Instructions for Use) — a core document tied directly to product clearance, labeling, and usability evaluation, and one of the most common reasons an FDA 510(k) submission stalls. This second installment of our Manuals Under Regulatory Scrutiny series maps the IFU and labeling requirements that medical device manufacturers most often run into when pursuing FDA 510(k), Health Canada, and MDSAP, and explains why regulatory strategy and document production have to be managed together.

“The product passed — but the manual may delay launch”

After submitting an FDA 510(k), the message manufacturers hear most often is this: “We’ve received an Additional Information (AI) Request.” A 510(k) review typically takes six to nine months — but a single AI Request can stretch that past a year.

What triggers most of those requests? It’s tempting to assume a safety or performance problem with the device. In practice, the leading cause is something else: inconsistencies between the IFU and the labeling. Missing safety warnings in the IFU, risk information that doesn’t match between the label and the IFU, misuse of ISO 15223-1 symbols, usability findings (IEC 62366-1) that never made it into the IFU, and poor IFU readability are the most common examples.

As the previous installment in this series argued, the manual is a direct object of regulatory review — and nowhere does that principle bite harder than in medical devices. This installment lays out the IFU and labeling landscape any manufacturer faces in reaching the US market, whether the company is based in the US or abroad.

Why the US market comes first

As the EU MDR has tightened, many manufacturers have postponed or deprioritized EU entry. The MDR’s requirement for IFUs in 24+ languages, Notified Body review backlogs (two- to three-year waits), and the per-member-state PRRC (Person Responsible for Regulatory Compliance) designation all raise the cost of entry.

The US, by contrast, has a single regulator (the FDA), a single-language (English) IFU requirement, and a well-defined 510(k) pathway — which keeps the barrier to entry comparatively low. It is also the largest single-country market in the world, which is why it is usually the first market manufacturers pursue. Canada (Health Canada) often follows as an adjacent step, and the MDSAP (Medical Device Single Audit Program) opens five markets at once: the US, Canada, Australia, Brazil, and Japan.

Item	United States (FDA)	Canada (Health Canada)	EU (MDR)
Regulator	Single (FDA)	Health Canada	Per-member-state + Notified Body
IFU language	English only	English + French (bilingual, legally required)	24+ languages required
Premarket pathway	510(k) / De Novo	License application (SOR/98-282)	Notified Body conformity assessment
Review timeline	510(k): 6–9 months avg. (1 year+ with an AI Request)	Typically follows US entry	NB review: 2–3 year wait
Barrier to entry	Comparatively low	Low	High (PRRC designation, etc.)
Multi-market expansion	MDSAP: 5 countries at once (US, CA, AU, BR, JP)	MDSAP-eligible	Not applicable

Core regulations for higher-risk (Class IIb) devices

Higher-risk devices — those in the upper tier of FDA Class II and in EU MDR Class IIb, such as neonatal devices, ventilators and anesthesia machines, X-ray/CT and diagnostic ultrasound, dialysis machines, aesthetic devices (HIFU and laser), and patient-monitoring systems — are subject to the following requirements for their IFU and labeling.

US FDA. The premarket pathway is either a 510(k) Premarket Notification or a De Novo Classification Request. Labeling is governed by 21 CFR Part 801, and the UDI (Unique Device Identification) system by 21 CFR Part 830. The eIFU (electronic IFU) is conditionally permitted for professional-use devices under 21 CFR 801.109, and the permitted scope continues to expand.

Canada (Health Canada). Governed by the Medical Devices Regulations (SOR/98-282). For Class III devices, a bilingual English/French IFU is legally required at the license-application stage.

Supporting standards. Usability engineering (IEC 62366-1), risk management (ISO 14971), medical device symbols (ISO 15223-1), information supplied by the manufacturer (ISO 20417), basic safety for electrical medical equipment (the IEC 60601-1 series), and safety of information for use (IEC/IEEE 82079-1) all apply alongside. Diagnostic imaging (X-ray/CT) and aesthetic devices add the relevant parts of the IEC 60601-2 series.

Common IFU and labeling problems

The IFU and labeling issues manufacturers most often encounter during FDA 510(k) review fall into the patterns below. Many surface not during IFU development but only at the review stage — and when they do, the IFU has to be rewritten and resubmitted, pushing the launch timeline back substantially.

• Mismatch between the risk management file and the IFU. Risks identified under ISO 14971 are not reflected in the IFU’s safety warnings, or only some are. This happens when the RA team writes the risk management file and the documentation team writes the IFU, with no consistency check between the two.
• Risk information that differs between the label and the IFU. A warning on the label is missing from the IFU, or the IFU’s conditions of use don’t match what the label states.
• Misuse of ISO 15223-1 symbols. Standard symbols — sterile, single-use, expiration date — are used in ways that diverge from ISO 15223-1, or the Symbol Glossary explaining the symbols used in the IFU is missing.
• Usability findings (IEC 62366-1) not reflected in the IFU. Use errors identified during usability evaluation are not carried into the IFU’s procedures and warnings.
• Poor readability in patient-facing IFUs. The FDA recommends plain language a patient can understand. An IFU translated literally from another language — or written in dense, technical prose — often gets flagged for readability.
• Inconsistency across multilingual IFUs. A safety warning present in the English source is missing or weakened in another language version. In markets where multilingual IFU consistency is itself a review item (such as the EU MDR), this becomes a direct finding.

Three blind spots in IFU development

Three recurring assumptions get manufacturers into trouble during IFU development:

“Risk management is RA’s job.” The ISO 14971 risk management file is written by the RA team — but reflecting its conclusions in the IFU is the documentation team’s responsibility. Without an information link between the two, consistency gaps open up between the risk management file and the IFU.

“Usability evaluation is just like a clinical trial.” IEC 62366-1 usability evaluation tests for the possibility that a user ignores or misreads the IFU. Those findings need to flow into the IFU, the UI text, and the labeling — yet usability results often never reach the documentation team.

“For the US, English is all you need.” The US is English-only, but Canada requires a bilingual English/French IFU, and some US submarkets (Puerto Rico, parts of Florida) make Spanish materials a practical necessity. Using MDSAP means five countries’ languages are needed at once.

All three trace back to a documentation team that operates in isolation from the RA, clinical, and engineering functions. The implication is that documentation has to be integrated into the clearance process from the start.

An integrated solution: Hansem Global and AWG

Manufacturers entering the US market typically run into a structural difficulty: they have to find a US regulatory consultancy to advise on FDA strategy and a separate language service provider (LSP) to produce the IFU and technical documents — and then manage the information flow between the two themselves. Beyond the cost and coordination burden, consistency problems tend to arise between the two partners’ deliverables.

To address this, Hansem Global has formed a strategic partnership with Amin Wasserman Gurnani (AWG), a Washington, D.C. law firm. AWG is a medical-device regulatory firm staffed by former FDA attorneys and scientific and engineering experts. For a manufacturer entering the US market, the two divide the work as follows:

• AWG: FDA product classification; 510(k), De Novo, and PMA clearance strategy; labeling and advertising review; post-market regulatory counsel; FDA inspection support; recall and dispute response.
• Hansem Global: standards-based, highly readable IFU authoring (IEC/IEEE 82079-1, ANSI Z535.6); technical illustration and visual-aid systems; multilingual manual production (20+ languages); and labeling production to the standardized elements of 21 CFR Part 801 — with regulatory adequacy confirmed in collaboration with AWG.

This integrated solution lets a manufacturer move on regulatory strategy and document production in a single decision, with FDA regulatory judgment provided by AWG and document production by Hansem Global. AWG sets the regulatory direction and reviews the labeling for compliance; Hansem Global turns that strategy into documents that are user-friendly, standards-based, and ready for that review. Hansem Global’s in-house technical illustration capability is particularly relevant here: well-designed visual aids reduce IEC 62366-1 use-error risk and cut translatable content by 15–30%, compounding both compliance and localization value.

Hansem Global’s operating assets in the medical device and life sciences space include:

• Four international certifications: ISO 9001 (quality management), ISO 17100 (translation services), ISO 27001 (information security), and ISO 18587 (MT post-editing)
• Compliance with GDPR and HIPAA data security standards
• Linguistic Validation services based on ISPOR guidelines (device usability evaluation, patient-facing materials, eCOA)
• A track record with global medical and life-sciences companies: localization of Seegene’s molecular-diagnostic reagent manuals into 20+ languages; 2M+ words for Invitae’s genetic analysis across 20+ languages; China-market localization of RenovoRX’s marketing materials
• Selected for the 2023 Diversity Alliance for Science (DA4S) mentorship program, receiving a year of life-sciences-translation business mentoring from AstraZeneca

Market entry stalls most often when product clearance and document production are handled separately. The manual is not a side task that comes after clearance — it is a core document that gets you through it.

Frequently asked questions (FAQ)

Q. How long does an FDA 510(k) review take?
A 510(k) review takes six to nine months on average. A single Additional Information (AI) Request, however, can push it past a year — and the most common trigger is not a safety or performance problem with the device, but inconsistencies between the IFU and the labeling.

Q. What usually triggers a 510(k) Additional Information Request?
The most common findings relate to the IFU and labeling: missing safety warnings in the IFU, mismatched risk information between the label and the IFU, misuse of ISO 15223-1 symbols, usability findings (IEC 62366-1) not reflected in the IFU, and poor readability in patient-facing IFUs. Many surface at the review stage rather than during IFU development, which delays launch.

Q. Is an English-only IFU enough for the US market?
For the US, an English-only IFU is sufficient. Canada (Health Canada), however, legally requires a bilingual English/French IFU, and some US submarkets (Puerto Rico, parts of Florida) make Spanish materials a practical necessity. If you use MDSAP to enter the US, Canada, Australia, Brazil, and Japan together, you will need multilingual IFUs across all five.

Q. Why do manufacturers often target the US before the EU?
The EU MDR carries a high barrier to entry: IFUs in 24+ languages, Notified Body review backlogs of two to three years, and a per-member-state PRRC designation. The US, by contrast, has a single regulator (FDA), a single-language (English) IFU requirement, and a clear 510(k) pathway — a comparatively low barrier, and the largest single-country market in the world.

Q. When is an eIFU (electronic IFU) allowed?
In the US, an eIFU is conditionally permitted for professional-use devices under 21 CFR 801.109, and the permitted scope keeps expanding. Restrictions still apply to general patient-use devices, so confirm the device’s classification and intended user (professional vs. patient) first.

Q. Which team owns risk management (ISO 14971) versus the IFU?
The ISO 14971 risk management file is written by the RA team, but reflecting the identified risks in the IFU’s safety warnings is the documentation team’s responsibility. Without an information link between the two, consistency gaps appear — which is why documentation should be integrated into the clearance process from the start.

Coming next in this series

The next installment covers manuals and regulation for industrial infrastructure and heavy equipment. We will look at the multilingual IFU mandate under Annex III of the EU Machinery Regulation (Reg. 2023/1230), effective January 2027; the regulatory differences across four equipment areas — forklifts, excavators, rail, and inspection equipment; and the consistency challenge of heavy-equipment manuals, where a single series splits into dozens of model variants operated across 20–40 languages — an area where the manual is a direct object of certification review.

Hansem Global, founded in 1990, is a language service provider with 35 years of experience producing multilingual manuals for global manufacturers. It holds a 35-year zero-incident manual track record and a 20-year zero-incident multilingual manual record, along with four international certifications (ISO 9001, 17100, 27001, and 18587). Ranked the world’s No. 49 LSP in CSA Research’s 2025 report, Hansem Global serves manufacturers across global markets. Through its strategic partnership with the Washington, D.C. law firm Amin Wasserman Gurnani (AWG), Hansem Global delivers an integrated solution for medical device manufacturers entering the US market.