Drugs

FDA Looking at Combo Product Human Factors

FDA is seeking comment by 5/3 on its February draft guidance on human factor studies and related clinical study considerations in combination product design and development. Writing in an FDA Voice blog post, associate commissioner for special medical programs Jill Warner and Office of Combination Products director Thinh Nguyen say that because the design of a combination product can have a significant impact on whether a given product is safe and effective for its intended use, human factors evaluations are a central consideration for the agency when it assesses combination products, particularly those that include certain devices.

The two say that the draft builds on principles articulated in earlier guidances that discuss human factors and medication error considerations for medical devices and drugs. It provides examples of combination products that include devices and describes recommendations for how to approach human factors studies for them, focusing on key challenges to developers such as:

·         the timing and sequencing of human factor studies in relation to overall development and study of a combination product;

·         how human factor studies compare with and relate to other types of clinical studies;

·         when changes to a combination product call for new human factor studies to be performed;

·         the role of simulated-use versus actual-use human factor studies; and

·         what information should be provided to FDA and when, to ensure timely feedback for a human factors study.

During the comment period, FDA is soliciting input on the overall guidance as well as asking that stakeholders submit examples of combination products in their comments and address whether they believe that human factor studies are needed for them. It also wants input on what challenges and development risks may arise if such studies are conducted before, in parallel to, or after major clinical studies for combination products.

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