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Human Factors Submissions and Threshold Analyses: FDA Drafts Guidance

Posted 28 September 2018 | By Zachary Brennan 

Human Factors Submissions and Threshold Analyses: FDA Drafts Guidance

The US Food and Drug Administration (FDA) on Friday drafted guidance to help sponsors with the content and submission procedures for use-related risk analyses, human factors (HF) validation study protocols and reports, threshold analyses and comparative use human factors study protocols and reports.

As part of evaluating drug and biologic products for safety and effectiveness, FDA will evaluate HF data submitted by sponsors in support of the product user interface when submission of such data is warranted. For abbreviated new drug applications (ANDAs), FDA says the sponsor can rely on the agency’s previous finding “so long as the sponsor can demonstrate certain findings” but for other products, including drug-device combination products, FDA says they “may warrant threshold analyses and additional data, such as data from comparative HF studies.”

FDA defines threshold analyses, which “generally are utilized in comparing two drug products,” as: “Conducted to identify differences (if any) that may exist between the proposed combination product’s user interface and the product it references. Consist of labeling comparison, comparative task analysis, and physical comparison of the device constituent part(s).”

The draft goes through the different threshold analysis and HF submission types and the information that a sponsor should include for each respective submission type. The draft also includes information on where to send threshold analysis or HF submissions and FDA’s review timeline.

But the draft does not describe, according to FDA, “when threshold analyses or HF submissions are warranted for any particular application pathway, the processes or procedures associated with their review, or the methods used by the Agency for evaluation. Furthermore, this draft guidance does not describe the methods used to design, conduct, or analyze HF studies.”

Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications: Draft Guidance for Industry and FDA Staff


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