Examining FDA’s New Patient Labeling Draft Guidance

In accordance with the increasing emphasis on human factors as it applies to medical products and their associated written materials, the FDA recently released the draft guidance document Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format. Instructions for use (IFU) are a critical element of the device user interface, and special considerations must be accounted for in their design.

This draft guidance provides industry with a good starting place for the basic principles of patient-use IFU design. Recommendations focus on creating readable, understandable documents that aim to help patients use products safely and correctly. Some areas, such as order of information display, may require further scrutiny to determine if recommendations are optimal. As the comment period closes (September 2, 2019), we can expect that the FDA will have robust feedback to incorporate into the final draft, which could include more leeway regarding specific design elements and recognition that additional customization may be required based on product needs.

Author(s) Source
Natalie Abts MED DEVICE ONLINE, 09 Sep 2019
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