This guidance provides recommendations for developing the content and format of a patient Instructions for Use (IFU) document for human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or a biologics license application (BLA). The IFU is written for patients (or their caregivers) who use drug products that have complicated or detailed patient-use instructions. The recommendations in this guidance are intended to help ensure that patients receive clear and concise information that is easily understood for the safe and effective use of such products. The recommendations in this guidance are also intended to help provide consistency to the content and format of IFU documents.
The recommendations in this guidance do not apply to labeling for stand-alone devices or for device constituent parts of cross-labeled combination products if the device constituent is marketed under a device authorization (i.e., devices that are not constituent parts of drugdevice, biologic-device, or biologic-drug-device combination products submitted under BLA or NDA), labeling for combination products for which the device constituent part provides the primary mode of action, or labeling intended for use by health care providers. The recommendations in this guidance also do not apply to stand-alone devices regulated under a BLA, such as devices associated with blood collection and processing procedures.
This guidance is one of several documents FDA is issuing to fulfill the performance goals under the fifth reauthorization of the prescription drug user fee program, the Prescription Drug User Fee Act (PDUFA) VI. In particular, this guidance relates to the PDUFA VI performance goal regarding guidance on patient-oriented labeling (e.g., IFU documents).
The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
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