Accredited vs. non-accredited labs for 60601 compliance in the US

EMC_noob

Starting to get Involved
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
 

dwperron

Trusted Information Resource
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

The FDA does not require ISO 17025 accredited calibrations on test and measuring equipment.
It is true that having accredited calibrations often smooths out audits by removing questions like "Can you prove this instrument is traceable to National standards?", justifying that your calibration is adequate, etc.
 

ca_moni

Involved In Discussions
I think that the OP was not referring to calibration lab but instead to test lab typically used for verification of compliance to safety /EMC recognized standard . I know that the FDA is now setting up a new "accreditation of the accrediter" program (ASCA) to be more confident on the test lab results even if they come from an accredited (CB-scheme or ILAC) test lab...
 

dwperron

Trusted Information Resource
I think that the OP was not referring to calibration lab but instead to test lab typically used for verification of compliance to safety /EMC recognized standard . I know that the FDA is now setting up a new "accreditation of the accrediter" program (ASCA) to be more confident on the test lab results even if they come from an accredited (CB-scheme or ILAC) test lab...

Good catch there, but the same principal applies to 17025 accredited test labs. An accredited lab has already done a lot of the back end work that auditors look for, and their certificates hold weight.
 
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