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US: FDA finalizes guidance on use of human factors studies in combination product development

2023/09/11  RAPS

The US Food and Drug Administration (FDA) finalized its guidance for industry on the use of human factors engineering (HFE) studies to support the development of combination products.

The final guidance, which is in a question-and-answer format, replaces a draft guidance issued in February 2016. It focuses on applying HFE principles for combination products that include a medical device with a drug or biological product that is submitted to the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), or the Center for Drug Evaluation and Research (CDER).

The final guidance modifies the draft by changing the format of the document to a Q&A format, deleting human factors information that is already addressed in other FDA guidance, and clarifying the definition of a combination product critical task. The final version also provides additional considerations to help identify those critical tasks.

The guidance states that “a key goal of applying HFE principles during development is to ensure that the user interface supports the safety and effectiveness of the combination product as a whole. The user interface for a combination product includes all points of interaction between the combination product and the user(s), including displays, controls, packaging, product labels, carton labeling, instructions for use, and training, if applicable.”

The guidance addresses whether a drug’s properties would affect how a user interacts with a combination product. It states that “the drug’s properties may influence and affect whether a user can successfully complete tasks when using the combination product. For example, the presence of a chemically irritating drug or a viscous drug formulation in combination with an injector-device may increase the risk for local pain on injection, either from drug toxicity or the fluid pressure in the interstitial tissue.”

The guidance also responds to a question related to the definition of a combination product critical task. It defines this term as 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.”

Another question relates to how FDA evaluates human factor validation studies. The guidance states that “from a practical perspective FDA recognizes that it may be impossible to design a user interface that is completely error-proof or risk-free, and some residual use-related risk may remain. The HF validation study results should be considered within the overall benefit-risk assessment of the combination product.”

Other topics include the differences between the use-related risk analysis (URRA) to support the user interface and other types of risk analysis. FDA states that “the URRA is a subset of the full engineering risk analysis for the device constituent part and combination product as a whole (including the drug constituent part). For the purposes of this guidance, the URRA is the systematic use of available information to identify use-related hazards and to estimate the use-related risk.”

FDA also provides hypothetical examples of what it considers a combination product critical task. For example, FDA does not consider removing the cap for an autoinjector a critical task because if the cap cannot be removed, the only consequence is the user is initially delayed in the sequence of tasks. “However,” said FDA, “there is no sense of urgency associated with completion of tasks for this hypothetical combination product and the user ultimately removes the cap.”

The guidance should be read in conjunction with the final guidance for industry on “Applying Human Factors and Usability Engineering to Medical Devices” and a final guidance on “Safety Considerations for Product Design to Minimize Medication Errors,” according to FDA.

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