What Goes in an IFU?
The contents of an IFU vary depending on the product, regulatory requirements, and market where it will be distributed. Depending on the product, an IFU may include:
- Product or device identification and intended use
- Instructions for use, including step-by-step procedures
- Warnings, cautions, and contraindications, when applicable
- Storage and handling information
- Symbols and their accompanying explanations
- Manufacturer information
- Product, reference, or part numbers
- Revision or document information
Because IFUs are controlled documents, manufacturers typically manage revisions carefully. The printed piece needs to match the approved version of the artwork provided for production.
IFU, User Manual, or Package Insert?
These terms can overlap, but they aren’t always interchangeable.
IFU — Instructions for Use
Information provided to explain how to use a product or device correctly and safely. IFUs are common with medical devices, diagnostics, pharmaceuticals, and other regulated products.
Package Insert
A printed insert placed inside product packaging. Depending on the product and industry, the package insert may contain the IFU or other required product information.
User Manual
Generally a longer document that provides more extensive operating or reference information. User manuals are often bound rather than folded into a compact package insert.
From a printing standpoint, the important details are the finished size, flat size, page count, fold or binding style, paper stock, and how the finished piece needs to fit into the packaging.
IFUs for Medical Devices
Medical-device IFUs can present some unique printing challenges. The content may be extensive, while the finished piece still needs to fit inside a package or carton.
Small Type
IFUs can contain a significant amount of information in a relatively small area. This can require smaller type than you would typically see in a brochure or marketing piece.
The important consideration is legibility at the finished size. Artwork should always be reviewed at 100% before production to make sure text, symbols, and other details remain clear. Our guide to fonts and text point sizes covers minimum sizes in more detail.
Symbols
Many medical-device IFUs use standardized symbols for information such as manufacturer identification, lot or batch information, expiration dates, storage conditions, single-use products, and instructions for use. FDA recognizes ISO 15223-1 as a consensus standard for medical-device symbols.
Symbols need to reproduce cleanly at their final size, so high-quality artwork is especially important. See vector and bitmap graphics for why symbol artwork should be vector.
Multi-Language IFUs
Products distributed in multiple countries may require several languages in the same IFU. As the number of languages increases, the available space and folding pattern become even more important.
Planning the panel sizes and fold sequence early can help make sure the finished piece is easy to handle and fits properly inside the package.
Common IFU Formats
IFUs can be produced in a variety of formats depending on the amount of information and the space available inside the packaging.
Folded Sheets
Accordion fold, trifold, z-fold, French fold, and many other fold styles create a compact finished piece that fits inside a carton or package.
Pharmaceutical Folds
A specialized folding style commonly used for package inserts where a relatively large sheet needs to fold down into a compact finished size.
Saddle-Stitched Booklets
Multi-page documents folded and secured with staples through the spine. These are useful when the amount of information is too extensive for a single folded sheet. See booklet binding for how each method compares.
Perfect-Bound Manuals
A bound format used for longer documents that require more pages and a more substantial finished piece.
The best format depends on several factors, including the amount of content, number of languages, finished size, package dimensions, paper stock, and how the IFU will be inserted into the packaging.
Before You Send an IFU to Print
A few details are especially important when preparing an IFU for production:
1. Confirm the Approved Artwork
Make sure the file you’re sending to the printer is the correct, approved revision. For regulated products, any update to the artwork at all means an update to the revision as well.
2. Provide a Print-Ready PDF
A properly prepared PDF with fonts embedded or outlined helps prevent text from changing or reflowing during production. For more specific file requirements, see our file preparation guide or just reach out and we’ll let you know exactly what we’ll need.
3. Check Symbols and Fine Details
Make sure symbols, graphics, and other small elements are high enough quality to reproduce clearly at their final size.
4. Review at 100%
Don’t rely only on how the file looks on your monitor. Print a sample at 100% and review the actual finished size. Small text and fine details can look very different when reduced to their final size.
5. Provide the Package Dimensions
If the IFU needs to fit inside a carton or other package, provide the folded dimensions or package cavity dimensions whenever possible. We will use that information to help determine whether the proposed format will work. Our box dimension guide explains how to measure.
How TPS Printing Handles IFU Printing
TPS Printing specializes in IFU printing for the San Diego biotech community and regulated product manufacturers nationwide.
We print IFUs, package inserts, clinical reference materials, and other regulated product literature in a variety of formats, including:
- Single-sheet folded inserts
- Accordion and Z-fold inserts
- Multi-panel inserts
- Pharmaceutical folds
- Saddle-stitched booklets
- Perfect-bound manuals
- Multi-language inserts
- Variable-data inserts
Our job is to produce the printed piece to the specifications and artwork provided by your team. TPS is not FDA or ISO certified. Your regulatory or quality team remains responsible for determining the required content, approvals, and compliance of the document.
If you’re working on an IFU and aren’t sure which fold, paper stock, size, or binding style will work best, we’re happy to go over the options with you! Call TPS Printing at 858.625.4111.
Frequently Asked Questions
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Related Pages
- IFU Printing Services: formats, stocks, and folds for Instructions for Use.
- IFU Booklets and Clinical Reference Manuals: specifications and quote request.
- Custom Packaging: cartons and inserts that ship alongside the IFU.
- Booklet Binding: saddle stitch, perfect binding, wire, and coil compared.
- File Preparation: what to send, how to set it up, and what we check.