FDA Draft Guidance on Human Factor Studies

The U.S. Food and Drug Administration (FDA) has issued a draft guidance that provides comprehensive instructions for conducting use-related risk analyses (URRAs) for drugs, biological products, and combination products. This guidance is intended for industry and FDA staff and outlines the key steps and considerations in conducting URRAs to support product development and marketing applications.

The guidance provides detailed instructions on the purpose and content of URRAs. It highlights the importance of URRAs in identifying human factors (HF) data needs during product development and their role in supporting marketing applications. The guidance is relevant to drug and biologic combination products with device components that are the subject of Investigational New Drug (IND), New Drug Application (NDA) or Biologics License Application (BLA) submissions.

Background information

The guidance highlights the regulatory requirements for demonstrating the safety and effectiveness of drug products. It outlines the role of URRAs in assessing use-related hazards and implementing risk controls to mitigate those risks. The URRA process should be initiated early in product development and updated throughout the product life cycle.

URRA development

The development of a URRA involves several critical steps:

• Identify user tasks: Develop a comprehensive list of all tasks involved in using the product, including physical and cognitive tasks.
• Identify potential user errors: Identify potential errors for each task, considering foreseeable misuse and using tools such as failure modes and effects analysis (FMEA).
• Identify potential harm: Assess the clinical impact of potential errors in use, considering both single and repeated errors.
• Categorise tasks: Categorise tasks as critical or non-critical based on their potential to cause harm.
• Identify risk controls: Identify and prioritise risk controls, focusing on eliminating risk through design rather than relying solely on labelling or training.
• Identify evaluation methods: Detail the methods used to evaluate the effectiveness of risk controls.
• Update the URRA: Continually update the URRA to reflect changes in product design or new risks identified during development and post-marketing.

Submitting an URRA

Sponsors may submit an URRA to justify that the results of an HF validation study do not need to be included in a marketing application or to support the design of a HF validation study protocol. Justifications should be supported by comparative analyses and other relevant information. The FDA encourages early engagement with the Agency to discuss the URRA and the HF development programme.

Illustrative examples

The guidance provides several illustrative examples:

• Pre-filled syringe for use by healthcare professionals: Justification for not submitting HF validation study results based on user familiarity and experience.
• Emergency auto-injector for lay users: Identification of the need for a HF validation study due to the high-risk environment of use.
• Auto-injector for lay users using URRA in conjunction with comparative analyses: Use of comparative analyses to support the justification for not submitting HF validation study results.
• Drug product with complicated dosing: Development of an HF validation study protocol due to the complexity of the dosing regimen.

Glossary and Appendix

The guidance includes a glossary of key terms and an appendix with an example format for an URRA table.

Conclusion

This draft guidance represents the FDA's current thinking on the development and submission of URRAs. It aims to ensure that medical devices are safe and effective by identifying and mitigating use-related risks throughout the product lifecycle. The FDA encourages industry stakeholders to review the document and provide feedback during the comment period.

For more details, the draft guidance document can be accessed through the FDA's official channels, and comments can be submitted electronically or in writing to the FDA's designated addresses.