FDA Issues Final Guidance on Instructions for Use Documents

July 14, 2022

The U.S. Food and Drug Administration has issued a final guidance, “Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products – Content and Format.”

The Instructions for Use (IFU) document is written for patients or their caregivers who use prescription drug and biological products that have complicated or detailed instructions. The recommendations in this guidance are intended to help provide consistency to the content and format of IFU documents and to help ensure that patients receive clear and concise information that is easily understood for the safe and effective use of such products.

This guidance finalizes the draft guidance that FDA issued in July 2019 titled “Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format, Guidance for Industry.” In the final guidance, FDA added clarifying language, consolidated discussions of human factors, and aligned the final guidance with the standards used in other Center for Drug Evaluation and Research policy documents.

This final guidance is a commitment included in the Prescription Drug User Fee Act (PDUFA) VI performance goals letter related to guidance on patient-oriented labeling (e.g., IFU documents).

Download the Final Guidance Document

Read the Federal Register Notice

Interested in learning more? Contact us today to find out how we can help with your global regulatory needs.




Agency Alerts

April 15, 2020

FDA Issues Product-Specific Guidance Documents for Chloroquine Phosphate and Hydroxychloroquine Sulfate

On Tuesday, April 14th, FDA released two product-specific guidance documents for chloroquine phosphate tablets and hydroxychloroquine sulfate tablets, two drugs being investigated as potential...

Read the Full Article
Medical Devices Agency Alerts

February 28, 2019

Draft Guidance: Requesting Nonbinding Feedback After an FDA Inspection of Your Medical Device Establishment

On Tuesday, February 19th, FDA published a draft guidance for medical device makers which identifies a process for companies to request nonbinding feedback on certain FDA Form 483 deficiencies noted...

Read the Full Article
Medical Devices Agency Alerts

November 30, 2018

FDA Announces Plans to Modernize its 510(k) Medical Device Approval Process

On Monday, November 26th, FDA announced changes to modernize the 510(k) clearance pathway, which is the most common medical device submission and allows for the allows for the “clearance of low- to...

Read the Full Article