Can I Talk to the FDA About Usability Issues During Design?

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CDRH Stresses Communication, Outreach on Human Factors

Designing Usable Devices

Manufacturers sometimes feel that talking to the FDA about risk management issues during the course of device design may not be a good strategy, believing that it may lead to more questions than answers. With respect to Human Factors, the FDA's Center for Devices and Radiological Health (CDRH) is encouraging manufacturers to meet with their Human Factors group to gain guidance on use error risks observed with similar devices and become familiar with the existing standards on human factors and usability practices.

Human Centered Strategies often accompanies clients on visits to the FDA to facilitate these discussions or present Human Factors and Usability engineering plans or evaluation results to help answer questions and clarify next steps in mitigating use error risk.

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