Software Usability & Medical Devices: Adhering to FDA Standard 62366

March 19, 2013

FDA Standard: 62366, Medical devices - Application of usability engineering to medical devices

ISO/IEC 62366 lays out a user-centered standard process that may ultimately help medical device manufacturers avoid user errors and maximize usability. Also included in the standard is a framework for the training of intended users and for the device’s accompanying documentation. It has expanded the scope of its preceding standard, which was solely for electrical medical devices (ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability), to include all medical devices. The 62366 standard is often used when applying for a product’s CE marking.

The main take-aways from 62366 are:
Things to AVOID when adhering to 62366 for an FDA submission:

  • Identifying relevant use scenarios
  • Generation of user requirements
  • Verifying these requirements through formative testing early and often
  • Building a usability file
  • Showing traceability of user requirements through the process
  • Inclusion of human factors in risk management activities
  • Using a “usability objectives” approach for validation testing
  • Stating compliance with 62366, but failing to submit a HF report (or worse, that is the HF report)
  • Using participant rating scales and usability measurement for validation testing
  • Not fully understanding how to evaluate use-related risk

In general, if the objective is to pass FDA pre-market approval, then adherence to 62366 is only one step in a multilayered process. But if the objective is to use the standard as a guide for developing a user-centered process, then it works out well. Though even in this case, the manufacturer will need to demonstrate they have assessed use error, implemented mitigations, and checked for residual risk.