CPC Comments on FDA’s “Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products—Content and Format: Draft Guidance for Industry”

On August 28, 2019, the CPC submitted comments on FDA’s “Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products—Content and Format: Draft Guidance for Industry.” While the CPC appreciates the value of this Draft Guidance in providing FDA’s expectations for IFUs to ensure a more consistent review experience, especially for combination products, the CPC has some concerns and suggestions for improvement. Specifically, we recommend that FDA revise the document to: (1) clarify that the final layout and content of an IFU should be based on outcomes of the human factors (“HF”) process and the expertise of instructional design professionals, and that the content and layout proposed within the Draft Guidance are suggested, but not required; (2) provide clearer guidance on the criteria by which a manufacturer decides whether a product requires an IFU; (3) clarify the scope of the Draft Guidance; and (4) provide additional guidance on how and when IFUs are to be submitted for review.