Summative Study before Phase 3?

Do you know if the Human Factors Summative study needs to be completed before start of Phase 3 or anytime during Phase 3?

What's "Phase 3" and where is that defined?

yodon said:

What's "Phase 3" and where is that defined?

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I'm familiar with IEC 62366 and the FDA Guidance on "Applying Human Factors and Usability Engineering to Medical Devices" and neither of those define phases.

I suspect the (good) point that @yodon is trying to make is: applying an ordinal value to something like a "hierarchy of phases" in the absence of any context (including which sub-forum the question is posted in) does not allow for a meaningful response.

For example, does "Human Factors and Phase 3" refer to

• An ordered phase in a specific type of development life-cycle?
• A response stage in the control of nuclear reactors during an emergency?
• A clinical trial?

I have gone through audit of it and I can say that no phases is defined in standard but minimum 5 subjects clinical data are required for summative evaluation .