FDA Human Factors Resources

Wendy News

FDA Draft Guidance on Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA:

This draft guidance provides FDA’s current thinking on general HF considerations and tools for developing a generic combination product under ANDA submissions. https://www.fda.gov/media/102349/download

FDA Guidance on Safety Considerations for Product Design to Minimize Medication Errors:

Looking for best practices from the FDA to improve your drug product and container closure design? See this guidance at https://www.fda.gov/media/84903/download

FDA Draft Guidance on Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors:

This guidance focuses on safety considerations for your product’s container label and carton labeling design. https://www.fda.gov/media/85879/download

FDA Perspectives on Human Factors in Device Development:

A great presentation of HF principles for device development can be found at https://www.fda.gov/media/84709/download

The Role of Human Factors Engineering in Combination Product Post Approval Changes (presented at PQRI Conference in 2019):

Expanding your combination product indications post launch? Visit https://pqri.org/wp-content/uploads/2019/04/1-PQRI-April-2019_CDER-HF-Presentation_QNguyen.pdf for information about how HFE can be applied.

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