Pre Design Verification

[Chitchat]

Does anyone have any guidance or information on pre-DV. When and why would you conduct pre-DV? Do you know if there is an FDA guidance on this subject or what would be their expectation? If one was conducting pre-DV, would validated test methods be required?

Thanks in advance for your input.

 

[yodon]

Not exactly sure what the intent of "pre-DV" would be. Nothing from FDA recognizes it (that I'm aware of).