Short answer: what to look for in a device's instructions for use
By SIGMedical.net Editorial Team | Updated September 24, 2026
Instructions for use (often called the IFU) are the step-by-step “how to” for a device. FDA's patient labeling guidance describes them as the steps for setting up, using, cleaning, troubleshooting, and storing a device. To read one well, find four things: the warnings, the cleaning and maintenance steps, the storage rules, and who to call when something goes wrong.
If a device problem may be causing serious harm right now, call your local emergency services first. Read the manual afterward.
Terms to know
- Instructions for use (IFU): the procedural “how to” part of a device's patient labeling. Labeling can also include risk and benefit information.
- Warning: in FDA's guidance, an alert about a situation that could cause death or serious injury if not avoided.
- Precaution: an alert about a situation that may cause minor or moderate injury, or damage to the equipment, if not avoided.
- Contraindication: a condition under which a device should not be used because the risk clearly outweighs any possible benefit.
- Checkout procedure: a check for safety and effectiveness. FDA gives examples ranging from a simple visual inspection to calibration and quality control checks.
- Recall: FDA's term for when a manufacturer takes a correction or removal action to address a problem with a device that violates FDA law.
How the pieces of an IFU differ
These sections are easy to mix up. Here is what FDA's guidance says about each one.
- Warnings and precautions tell you how to avoid hazards other than contraindications. FDA says an effective alert generally has a signal word (such as WARNING or CAUTION), a directive on what to do or avoid, the nature of the hazard, and the consequences of not following it.
- Cleaning is different from maintenance. The guidance says cleaning instructions should include supplies needed, step-by-step procedures, how often to clean, and what happens if you use improper cleaning solutions or methods.
- Maintenance should say which actions are the user's job and who does the rest. If some tasks belong to others, such as a biomedical engineer, the guidance suggests making that split clear.
- Storage should describe how to prepare the device for storage, the storage conditions, and what can happen with improper or extended storage.
- Troubleshooting covers problems with setup, operation, or maintenance. It should also flag problems users should not try to fix themselves and say how to get help.
A step-by-step field guide
Use this list when you get a new device or revisit one you already own. It is a reading aid, not medical advice.
- Find the newest version. The guidance says FDA requires dated labeling for prescription devices (21 CFR 801.109(e)) and recommends it for all other devices. Look for a date. The guidance also suggests manufacturers consider posting patient labeling on their websites so patients can get up-to-date information, so check there too.
- Read the warnings first. The guidance says general warnings and precautions should appear early in the labeling. Note every item that says “do not” or “avoid.” Some warnings may instead sit next to the step they relate to.
- Check who the device is for. Look for the indications for use and any contraindications. If you're unsure whether they apply to you, write down the question for your clinician.
- Do the setup and checkout steps as written. Note when to check out, such as at setup or before each use.
- Mark your maintenance tasks. Highlight what the IFU says you must do, what someone else must do, and how often.
- Copy the cleaning rules. Note the approved supplies and the frequency. The guidance says instructions should describe what happens with improper cleaning solutions or methods.
- Record the storage conditions. Note how to prepare the device for storage and what the manual says about long-term storage.
- Check accessories. The guidance says labeling may include a general warning about problems from using accessories other than those the manufacturer recommends.
- Save the help contacts. Write down the manufacturer's assistance number and your clinician's number in one place.
- Learn where to report problems. FDA encourages voluntary reports of device problems through MedWatch, by phone at 1-800-332-1088 or online.
Why the IFU is not the whole safety picture
An IFU describes the device as its manufacturer intends it to be used. FDA separately monitors reports of adverse events and other problems, and it posts Medical Device Safety Communications about current issues. Those notices are published on FDA's website, apart from any manual that came with your device. One example on the public list is a February 2025 notice alerting patients to regularly check diabetes-related smartphone device alert settings, especially after phone hardware or software changes.
Our editorial suggestion, not an FDA instruction: check both your IFU and FDA's notices for your device type.
- Look at FDA's Medical Device Safety Communications and recall pages for your device type or brand.
- FDA offers email updates on recalls and safety communications.
- Use FDA's consumer resources to learn whether a device has been 510(k) cleared or recently approved.
Questions to bring to a clinician or the manufacturer
- Which maintenance tasks am I responsible for, and which should someone else do?
- How often should I run the checkout steps?
- Which cleaning products are approved, and what happens if I use a different one?
- What are the storage conditions, and does long-term storage change anything?
- What should I do if the device alarms, fails, or gives a result that doesn't fit how I feel?
- Where can I find the current version of the IFU?
What this guide cannot tell you
- The IFU, warning, maintenance, and storage details here come from FDA's 2001 patient labeling guidance. It is written for manufacturers and does not bind the public. Any later FDA update or replacement isn't covered here; check FDA's website.
- That guidance covers patient and lay caregiver labeling. It does not describe professional-use labeling or rules outside the United States.
- Manuals vary, and not every device has every section. The guidance says patient labeling is usually not necessary for some devices used only by health care practitioners, such as surgical instruments.
- Your device's own IFU and your clinician's directions come first. Do not change how you use a prescribed device without talking to your clinician or the manufacturer.
Sources and what each one supports
- U.S. Food and Drug Administration, Consumers (Medical Devices), content current as of August 3, 2026. This page supports the recall definition, the MedWatch reporting details, and the pointers to 510(k) and approval lookups. It does not itself describe what an IFU contains.
- U.S. Food and Drug Administration, Medical Device Safety Communications, content current as of June 3, 2026. This page supports the description of safety communications, the example notice, and the email update option.
- U.S. Food and Drug Administration, Guidance on Medical Device Patient Labeling (April 19, 2001). This document supports the IFU, warning, precaution, cleaning, maintenance, storage, and troubleshooting descriptions.
Read about the site's editorial process in our Editorial Policy.
Educational disclaimer and independence
This article is general educational information. It is not medical advice, diagnosis, or treatment, and it does not replace your device's instructions or your clinician's guidance. Read our Medical Disclaimer. SIGMedical.net is an independent editorial publication, not a clinic or device maker. The “Medical” in the domain name reflects its previous ownership and does not indicate physician authorship, clinical practice, or licensure. The domain was previously associated with SIG Medical Inc., and this site is not affiliated with that company or any former entity. See our Non-Affiliation Notice.
Next up
Leave a Reply
You must be logged in to post a comment.