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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 must be managed together.
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Hansem Global
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.
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.
The IFU and labeling issues manufacturers most often encounter during FDA 510(k) review fall into the patterns below. Many surfaces are 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.
Three recurring assumptions get manufacturers into trouble during IFU development:
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.
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:
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:
Market entry stalls are 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.
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 regulations 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.
Hansem Global is an ISO Certified and globally recognized language service provider. Since 1990, Hansem Global has been a leading language service company in Asia and helping the world’s top companies to excel in the global marketplace. Thanks to the local production centers in Asia along with a solid global language network, Hansem Global offers a full list of major languages in the world. Contact us for your language needs!
