IFU stands for "Instructions for Use". It is a form of prescription drug labeling created for drug products that have complicated or detailed patient-use instructions. IFUs are reviewed and approved by the FDA under an NDA, BLA, or ANDA. They should contain detailed, action-oriented, step-by-step written and visual instructions provided in a patient-friendly manner, including written instructions on preparation, administration, handling, storage, and disposal.
IFUs are not only used for prescription drug labeling, but also for medical instruments and devices. For example, IFUs for medical instruments and devices include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device.
In summary, IFU is a document that provides detailed instructions on how to use a product, such as prescription drugs, medical instruments, and devices.
