Standardized service

Instructions for Use (IFU) / User Manual Review

We review device instructions for use (IFU) and user manuals, checking that indications, contraindications, warnings, operating steps, and post-market information align with FDA requirements and your device filings.

RegulatorU.S. FDA

ScopeIFU and user manuals

Initial ReviewAbout 3-4 weeks

DeliverablesFindings list and re-review comments

On this page

What this service is

The Instructions for Use (IFU) is part of device labeling and is subject to FDA labeling regulations. Its indications, contraindications, warnings and precautions, and operating instructions must be consistent with the device's intended use and premarket submission information.

For prescription devices and other professional-use products, the IFU must also meet specific identification and warning format requirements; deficient IFU content likewise constitutes misbranding.

FD&C Act §50221 CFR Part 80121 CFR 801.109

Who needs it

Device manufacturers preparing for U.S. export that need an English IFU compliance review

Companies that need to strengthen the IFU section during a 510(k) submission

Companies whose IFU content changed and needs a fresh consistency check

Prerequisites and sequence

Device classification and intended use are confirmed; if a 510(k) is cleared, provide the cleared indications wording.
A current version of the IFU or user manual is available (editable format preferred).
Related risk analysis and labeling information can be provided for cross-checking.

Who holds regulatory responsibility

The manufacturer/labeler is responsible for IFU content. We provide regulatory compliance and consistency review comments; you confirm the final technical content.

Materials we need from you

Current IFU/user manual (editable format such as Word preferred)

Intended use and indications statement

510(k) clearance information (if applicable)

Device labeling and risk management materials (if available)

Process

01
Confirm device classification and the applicable IFU regulations and guidance
02
Review indications, contraindications, warnings, operating, and maintenance instructions item by item
03
Check consistency between the IFU, labels, and submission documents
04
Issue a findings list with item-by-item correction recommendations
05
Re-review your revised version

Deliverables

IFU findings list with regulatory references

Annotated revision recommendations

One round of post-correction re-review comments

Timeline

The initial review is typically completed about 3-4 weeks after receiving complete materials; longer IFUs or specialized devices take proportionally longer, and re-review timing depends on implementation speed.

Scope

What we provide

IFU regulatory compliance review
Consistency check against labeling and submission documents
Findings list and correction recommendations
One round of post-correction re-review

What is not included

IFU authoring and translation (the service reviews existing documents)
Layout and print production
Writing clinical evaluation or performance study content

What usually follows

FDA 510(k) Submission Device Label Review

Common pitfalls

IFU inconsistent with the cleared indicationsIndications, contraindications, and warnings in the IFU must align with the device's intended use and any 510(k) clearance. An IFU written broader than the cleared scope likewise constitutes misbranding.

Treating translation as a compliance reviewTranslating a Chinese IFU into English does not make it FDA-compliant. Regulatory structure, required content, and warning formats must each be checked, and the finalized English version should be reviewed again for consistency.

Missing prescription-device identification and warning formatsIFUs for prescription devices must meet specific identification and warning format requirements. Writing them like an ordinary device manual fails those professional-use requirements outright.

Pricing

Pricing depends on your product, quantity, and target market. Submit your product details and we will come back with a defined scope and quote.

Request a quote

FAQ

What is the difference between IFU review and label review?

Label review focuses on identification information on packaging and the device itself; IFU review covers the manual's body text in greater depth — operating steps, contraindications, warnings. Both fall under FDA labeling and are best reviewed together.

Can you review an IFU that is not yet in English?

Yes. You can provide the Chinese version first, and we will comment on regulatory structure and required content. The U.S. market ultimately requires an English version, which should be checked again once finalized.

Can you handle the IFU inside a 510(k) submission?

Yes. A 510(k) submission includes labeling and IFU sections, and the findings from this service feed directly into submission preparation. If you engage the full 510(k) service, IFU review is coordinated within it.

Related services

Device Label ReviewWe review primary and secondary device labels against FDA labeling regulations (21 CFR Part 801 and related rules), flag non-compliances, and recommend corrections — reducing misbranding and port detention risk.510(k) SubmissionThe 510(k) is the premarket pathway for most Class II and some Class I devices: demonstrating to the FDA that your device is substantially equivalent to a legally marketed predicate. We support the full project from strategy to clearance.Device ListingAfter establishment registration, every device marketed in the U.S. must be listed with the FDA, declaring its product code, proprietary name, and premarket submission number. Listing is handled per device, and we complete each filing with you.

Disclaimer

IFU review comments reflect a general reading of current regulations and FDA guidance and are not legal advice. The manufacturer is responsible for the technical and clinical accuracy of the IFU.