Category: Content Transparency & Labelling

Instructions for Use

Also known as: IFU, IFU document, instructions for use document

Simply put

Instructions for Use (IFU) is documentation a manufacturer provides to tell users how to use a medical device or certain prescription drug and biological products, including their intended purpose, proper use, and any precautions. It is meant to help users apply the product safely and effectively, and to communicate essential information clearly. The specific content, format, and whether an IFU is required depend on the product and the applicable regulatory framework.

Formal definition

In the medical-device and drug-labeling context, an IFU is manufacturer-supplied information intended to inform the user of a product's intended purpose, proper use, and relevant precautions to support safe and effective use. Under the EU Medical Device Regulation (MDR), the term refers to information the manufacturer provides regarding a device's intended purpose and correct use; in some frameworks certain low-risk devices may be supplied without an IFU where safe use is self-evident, so an IFU is not universally mandatory across all products. In the U.S., FDA has issued guidance on the content and format of patient IFU documents for human prescription drug and biological products (final guidance, July 2022); as guidance, it sets out recommendations rather than binding requirements. This entry addresses IFU as used in medical-device and drug labeling only; any use of the term to describe AI-system or model documentation is out of scope and not supported by the cited evidence.

Why it matters

In medical-device and drug labeling, the Instructions for Use (IFU) is a primary channel through which a manufacturer communicates a product's intended purpose, correct use, and relevant precautions to the people who rely on it. Clear IFU content supports safe and effective use, and industry sources describe such information as critical to helping patients and clinicians receive concise information that is easily understood. Where an IFU is incomplete, unclear, or poorly translated, users may misapply a device or product, which is why the document is treated as an important element of labeling rather than an afterthought.

Regulatory expectations for the IFU differ by jurisdiction and by product, so professionals should not assume a single universal requirement. Under the EU Medical Device Regulation (MDR), the term refers to information the manufacturer provides regarding a device's intended purpose and correct use, and in some frameworks certain low-risk devices may be supplied without an IFU where safe use is self-evident. In the U.S., FDA issued final guidance in July 2022 on the content and format of patient IFU documents for human prescription drug and biological products; as guidance, it sets out recommendations rather than binding rules. Whether an IFU is required, and what it must contain, therefore depends on the specific product and the applicable framework.

Because the term "Instructions for Use" appears across several domains, readers in AI governance and model risk management should be careful not to import this medical-device meaning into documentation for AI systems or models. The evidence supporting this entry concerns medical-device and drug labeling only; any use of "IFU" to describe AI-system or model documentation is out of scope here and is not supported by the cited sources.

Who it's relevant to

Medical device manufacturers

Manufacturers are responsible for supplying IFU information about a device's intended purpose, proper use, and precautions. They must determine, based on the product and applicable framework such as the EU MDR, whether an IFU is required and what content and format are appropriate, recognizing that certain low-risk devices may in some cases be supplied without one where safe use is self-evident.

Prescription drug and biologics manufacturers (U.S.)

Companies developing human prescription drug and biological products can consult FDA's July 2022 final guidance on the content and format of patient IFU documents. Because it is guidance, it provides recommendations rather than binding requirements, and manufacturers should confirm the obligations that apply to their specific product.

Regulatory affairs and labeling professionals

Those preparing or reviewing labeling need to scope IFU obligations correctly to jurisdiction and product type, distinguishing binding law from guidance, and avoiding the assumption that an IFU is universally mandatory for all devices or all drug and biological products.

Clinicians and patients as end users

Healthcare providers and patients rely on the IFU to understand a product's intended purpose, correct use, and precautions so they can use it safely and effectively. Clear and understandable information supports appropriate use, though the level of detail provided depends on the product and framework.

AI governance and model risk professionals (scope caution)

Professionals in AI governance or model risk management should note that this medical-device and drug-labeling meaning of IFU does not transfer to AI-system or model documentation. Using the term for AI documentation is out of scope here and is not supported by the cited evidence.

Inside IFU

Directions for use

Step-by-step instructions describing how the product is to be operated, administered, or applied so that a user can achieve safe and effective use as intended.

Indications and intended use

A statement of the conditions, purposes, or populations for which the product is intended, which frames the scope within which the accompanying instructions apply.

Warnings, precautions, and contraindications

Information alerting the user to circumstances in which the product should not be used, or should be used with particular care, to reduce the risk of harm.

Handling, storage, and disposal information

Guidance on conditions for storing, maintaining, and disposing of the product where relevant to safe use.

Identifying and manufacturer information

Details that identify the product and the responsible manufacturer or supplier, allowing users to trace and obtain further information.

Common questions

Answers to the questions practitioners most commonly ask about IFU.

Is an Instructions for Use (IFU) document required for every medical device and prescription drug?

Not necessarily. While many medical devices and prescription products are accompanied by use instructions, certain low-risk devices may be supplied without a separate IFU when their safe use is self-evident. Both U.S. FDA rules and, in the EU, the Medical Device Regulation contemplate exemptions of this kind for defined device categories. The precise conditions for omission are set by the applicable jurisdiction and device classification, so the IFU should not be described as an absolute universal requirement.

Does 'Instructions for Use' in this context refer to documentation for AI systems or AI models?

No. As commonly used in the medical-device and drug/biologic labeling context, IFU refers to product use instructions for those regulated products. It is not the same as AI governance or AI model documentation artifacts, which are out of scope for this entry. Applying an IFU template to an AI system, or assuming AI-specific content such as performance metrics or human-oversight provisions belongs in an IFU, can mislead readers about regulatory expectations for either domain.

Which regulatory bodies govern the content and format of an IFU?

The applicable requirements depend on jurisdiction and product type. In the United States, the FDA addresses labeling and use instructions for medical devices and for drugs and biologics through its regulations and guidance. In the European Union, requirements for device instructions are addressed under the Medical Device Regulation. Because these regimes differ in scope, terminology, and legal effect, an IFU prepared for one jurisdiction should not be assumed to satisfy the requirements of another.

Is FDA's guidance on instructions for use binding law?

FDA guidance documents generally represent the agency's current thinking and are not legally binding in the way regulations are, though they indicate expectations manufacturers commonly follow. Where FDA has issued guidance addressing instructions for use as final rather than draft, it reflects the agency's settled position but still carries the general non-binding status typical of guidance. Practitioners should confirm the current status and version of any specific guidance before relying on it.

How should an organization determine whether a given device needs an IFU?

Determination typically turns on the product's classification, its risk profile, and whether safe use is self-evident to the intended user under the applicable jurisdiction's rules. Because criteria and exemptions vary between regimes such as the U.S. FDA framework and the EU Medical Device Regulation, organizations generally assess the requirement against the specific regulation governing the product in each market where it is placed.

Should the same IFU be used across multiple jurisdictions?

Not without review. Content, language, and format expectations differ across regulatory regimes, and an exemption or requirement in one jurisdiction may not hold in another. Organizations commonly review and, where needed, adapt IFU content for each market rather than assuming a single document satisfies all applicable frameworks. The specific obligations should be confirmed against the governing regulation in each jurisdiction.

Common misconceptions

Every medical device and every prescription drug or biologic must be supplied with an Instructions for Use document.

An IFU is commonly required, but it is not universal. Under both U.S. FDA rules and the EU Medical Device Regulation (MDR), certain low-risk devices may be supplied without an IFU where safe and correct use is self-evident. Requirements vary by product classification and jurisdiction.

FDA's guidance on Instructions for Use is still a draft and therefore only preliminary.

FDA issued IFU guidance as final guidance on July 22, 2022. As guidance, it represents the agency's current thinking and is generally non-binding rather than law, but it is not in draft status.

An 'Instructions for Use' is the same as an AI model card or AI system documentation, so the same template applies.

In this glossary the AI-governance sense of the term is out of scope; the entry addresses IFU as used for medical devices and drug/biologic labeling. AI-system documentation such as performance metrics or human-oversight provisions arises under different frameworks and should not be assumed to be part of an IFU.

Best practices

Confirm whether an IFU is actually required for the specific product by checking its classification and the applicable jurisdiction's rules, rather than assuming every device or drug needs one.

Distinguish the U.S. FDA and EU MDR requirements for IFU content and format instead of treating them as interchangeable, and scope each to its own jurisdiction.

Treat FDA IFU guidance as final but non-binding agency thinking, and document how your approach aligns with or reasonably departs from it.

Ensure the IFU addresses directions for use, indications, warnings, and handling information appropriate to the product, and avoid importing AI-specific content that does not belong in device or drug labeling.

Keep the IFU consistent with the product's stated intended use and indications so that instructions do not extend beyond the authorized scope.

Record the version and effective date of any regulatory guidance you rely on, since guidance may be updated over time.