Medical device usability: FDA guidance and IEC 62366 as key allies for safety

At SanRubio, LLC we believe usability is essential to ensure that medical devices are not only effective but also safe. The way users interact with a device can determine whether it delivers successful treatment or leads to an adverse event. For this reason, both the international standard IEC 62366-1 and the FDA’s guidance on human factors and usability are fundamental tools for manufacturers seeking access to the U.S. market.

Medical devices usability

FDA guidance on medical device usability

The final guidance published by the FDA in 2016 explains how to apply human factors engineering to medical device design. Its primary goal is to reduce risks associated with use errors that could compromise patient safety.

Key aspects highlighted by the FDA include:

• Assessing risk based on the severity of potential harm caused by a use error.

• Conducting usability testing as part of design controls.

• Considering the full user interface, including controls, displays, labeling, packaging, and instructions for use.

• Documenting usability strategy and results as part of regulatory submissions when required.

  
  

When the FDA requires usability testing

The FDA does not expect usability data in every case. However, it does require validation studies when a use error could result in serious harm to the patient or user. This applies to 510(k) and De Novo submissions when:

• The device has a new or significantly modified user interface.

• The device carries critical risks that cannot be mitigated only through training or labeling.

• A use error could have serious consequences for safety or effectiveness.

  
  

In such cases, the FDA expects validation testing with representative users to demonstrate that the interface supports safe and effective use. For low-risk devices, or when there are no significant interface changes, usability data may not be necessary.

The IEC 62366-1 standard

IEC 62366-1:2015 provides a structured framework to identify and control usability risks throughout the device life cycle. It introduces key definitions, distinguishes between normal and abnormal use, and describes how to integrate usability engineering into product development.

The standard also emphasizes post-market surveillance, enabling manufacturers to address usability risks that may emerge once a device is in clinical use.

Differences and complementarity

Although the FDA guidance and IEC 62366-1 take different approaches, they are complementary in practice:

• IEC 62366-1 offers an internationally recognized process for embedding usability into device development.

• FDA guidance tailors this process to the U.S. regulatory framework, emphasizing validation testing when critical use-related risks are present.

• Together, they give manufacturers a solid roadmap: safe design aligned with international standards and compliance with U.S. regulatory expectations.

  
  

Best practices for the industry

• Integrate usability strategy early in the design phase.

• Conduct formative evaluations with prototypes to identify potential use errors.

• Prepare clear evidence of validation studies when required for regulatory submissions.

• Consider a Pre-Submission meeting with the FDA to align on usability expectations before a 510(k) or De Novo submission.

  
  

Conclusion

Usability is not only a regulatory requirement but also a decisive factor in patient safety and market acceptance. Applying IEC 62366-1 as a design framework while aligning documentation with FDA guidance allows manufacturers to minimize risk, improve design, and streamline regulatory approval. At SanRubio, LLC we support companies in integrating both approaches to achieve successful access to the U.S. market.

🤝 How Sanrubio, LLC supports you

At Sanrubio, LLC, based in Miami, we offer:

• Tailored regulatory consulting: From pre-submission planning to 510(k) or De Novo submission preparation.

• Strategic location: Miami serves as a gateway for international manufacturers entering the U.S. market.

• Free consultations: Discuss your project with our experts and optimize your regulatory pathway.

  
  

Ready to bring your medical device to the U.S. market? 

CONTACT US for personalized consulting and take the next step in your medical device journey with confidence

Contact us