Hello everyone, I am developing a class IIb laser / robotics device for the US market (through 510k) and was wondering if using an accredited lab for our test reports (60601-1, 60601-1-2, 60601-2-22) is a requirement by the FDA? The plan is to write these reports ourselves from the data that we get from a non-accredited lab here in Denmark. I understand if the FDA prefers seeing reports written by accredited test labs, but if it isn't strictly necessary, then I would like to give the in-house report writing a shot.
Thank you
Thank you