Human Factors and Usability Testing for a 510(k) Submission

Usability files for CE Marking of Medical Devices are often rejected by the FDA, because the usability testing satisfies IEC 62366-1, but it does not meet the requirements of the FDA's guidance on Human Factors. This video briefly explains why. Rob Packard will speak more on this at the 510(k) Workshop in Amsterdam. The workshop begins on October 10, 2018 @ 9:00am. The workshop is two days and the cost is $600 total. You can register for the event at medicaldeviceacademy.com/amst....

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Do we need the summative test report for a 510k?

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For a device that has an identical user interface to a predicate device, usability testing is not normally required. For a device with a different user interface, the summative testing report is needed. However, you also need a URRA, the protocol for the summative study, and the raw data. Manual instruments are less likely to have human factors requirements for a 510(k), but software products typically require human factors testing--including SaMD that creates a report to make sure the user can understand the report.