USFDA vs NRTL/IEC 17025 Differences - Compliance testing lab

DRA

Starting to get Involved
#1
Hi,

Need clarification on the USFDA requirements for compliance testing lab, guidance documents if any and what is the major difference between USFDA requirement Vs IEC 17025/NRTL.


please help.
 
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yodon

Staff member
Super Moderator
#2
I was really hoping someone would jump on this. I think this is going to take a bit of unwinding so here goes...

IEC 17025 is just a standard for providing test services (among other things). Many companies that are not NRTLs are certified to 17025.

An NRTL is a test lab recognized by OSHA and allows the lab to give authorization to apply a safety mark (e.g., UL, ETL, etc., for compliance to 60601-1). I don't think a test lab can be an NRTL without certification to 17025.

My understanding is that, in the US, hospitals won't allow devices in unless they have a safety mark. I've never tried it, but it *may* be possible to submit data for FDA clearance (presuming such data is required) demonstrating compliance to 60601-1 without going through an NRTL. (And I know you can do the testing outside of an NRTL, submit the data to an NRTL, and if all is good, get approval to apply a safety mark).

I *think* this is how it is; hopefully if someone knows otherwise, they'll weigh in.
 

DRA

Starting to get Involved
#3
Hi yodon,

Thanks for clarifying me.

Can you share me any official website links or any documents or objective evidence in this regards.

Please do the needful.

Thanks
 

DRA

Starting to get Involved
#5
Nothing really specific, but:
Hopefully that helps some.


Thanks a million.
I just required few more clarifications
Is there any mandatory requirements in US FDA that a medical device compliance testing should be conducted only with NRTL lab and the testing conducted in NRTL lab will only accepted by US FDA.do I get any CFR evidences. Please
 

yodon

Staff member
Super Moderator
#6
Hmm... I don't know. Never tried. I don't think there's anything in the regulations about it. As mentioned earlier, to get a safety mark, the test lab has to be an NRTL and we've always needed to apply a safety mark. I believe I've seen products cleared by FDA when tested to 60601-1 in labs outside the US so I expect it's possible. No direct experience, though.
 

dwperron

Trusted Information Resource
#7
My experience is that NRTL labs require 17025 calibrations, but they do not comply with 17025. I have worked with UL certified testing labs, and one of UL's requirements is that the equipment used by the testing lab receives 17025 accredited calibrations.
 
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