D
This is my very first post here...however I use this website a lot as a resource.
I am really stuck on one point that I need to address prior to submitting my response for additional information to the FDA.I am hoping someone can shed some light on the reporting requirements for ground leakage for a powered wheelchair that I am trying to receive 510(k) clearance for.
A little background:
- The wheelchair is CE marked.
- The controls for the device have 510(k) clearance.
- The patient leakage testing was done to ISO 7176-14 no actual values available just "pass" or "fail
- FDA says that IEC 60601-1:2005 3rd Ed. requires the reporting of actual values. However the device wasn't tested to this standard according my client.
Given the information above do I actually have to report actual ground leakage values to the FDA based on the fact that the device was tested to ISO 7176-14 (a recognized standard)?
Can some please tell me what ISO 7176-14 requires for ground leakage and what must be reported?
Thank you in advance for any input.
: