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# Patient Labeling Use Guidance Out
- URL: https://www.fdaweb.com/patient-labeling-use-guidance-out/
- Published: 2019-07-08T12:00:00.000Z
- Updated: 2026-09-15T01:36:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144459

FDA has published a draft guidance, *Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products—Content and Format*, with recommendations for developing the content and format of an Instructions for Use (IFU) document for human prescription drug and biological products and drug-device or biologic-device combination products submitted under an NDA or BLA. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/instructions-use-patient-labeling-human-prescription-drug-and-biological-products-and-drug-device?utm%5Fcampaign=SBIA%3A%20FDA%20Draft%20Guidance%3A%20Instructions%20for%20Use%20Patient%20Labeling%20for%20Human%20Prescription%20Drug&utm%5Fmedium=email&utm%5Fsource=Eloqua) says the IFU is developed by applicants for patients who use drug products that have complicated or detailed patient-use instructions. It says the guidance’s recommendations are intended to help develop consistent content and format across IFUs and to help ensure that patients receive clear, concise information that is easily understood for the safe and effective use of such prescription products.

Recommendations in the draft do not apply to labeling for standalone medical devices legally marketed under medical device application types and do not apply to devices regulated under a BLA.

The guidance is one of several documents FDA is issuing to fulfill PDUFA 6 performance goals.