FDA Final Guidance Tackles Human Factor Studies for Combination Products

The FDA’s latest final guidance features questions and answers on how to apply human factors (HF) engineering principles when developing combination products, clarifying how the uniqueness of these products affect HF engineering considerations for industry and agency staff.

The 14-page document, “Application of Human Factors Engineering Principles for Combination Products: Questions and Answers,” finalizes a draft guidance from February 2016 and should be used alongside the guidances “Applying Human Factors and Usability Engineering to Medical Devices” and “Safety Considerations for Product Design to Minimize Medication Errors,” as well as other FDA product development guidances, advised the agency.

Crucially, the FDA said, the HF final guidance defines a combination product critical task, which is a “user task which, if performed incorrectly or not performed at all, would or could cause harm to the patient or user, where harm is defined to include compromised medical care.”

The guidance does not “address HF considerations for combination products submitted” in an ANDA or BLA for a proposed biosimilar or interchangeable biosimilar product, nor does it address label comprehension studies for nonprescription uses.

Read the final guidance here.

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