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

#1
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
 
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yodon

Staff member
Super Moderator
#2
Don't know, never tried, probably wouldn't want to try! :) I'm sure the first question would be to ask if the data are reliable. So while it may be possible, it's likely to get scrutinized quite heavily.

On a bit of a side note, FDA released guidance last year on an Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. So it would seem they are wanting more than even being accredited; now they want the lab to undergo their accreditation scheme. I believe I saw that UL actually achieved this.
 

Peter Selvey

Staff member
Super Moderator
#3
I would suggest adding more information in the report.

At one extreme the evidence could just be a list of clauses in a table with simply "Pass" or "N/A" written, which I have sometimes seen as an MDD auditor. A report like that should fail a regulatory review.

The other extreme would be detailed report showing where necessary a reasoned assessment, links to supporting material and test data, and where tests are done, sample identification, raw data, calculations, equipment used, calibration status, test date, location, environment, notes etc, plus keep on file the qualifications of persons actually doing the tests and actual calibration records.

That's the kind of stuff an accredited laboratory has to keep but they may not put it all in the report. That's the benefit of accreditation.

One option would be to ask your non-accredited lab to bundle all these background records either in the report, or as part of package, which is then reviewed for completeness by your company. Another option would be to audit them (as a critical subcontractor) and prepare an agreement that they will keep these records on your behalf for the period required by regulations, and keep records of the audit/agreement in your supplier assessments.

For IEC 60601-1-2 the non-accredited status could be more difficult to defend as the actual tests and equipment are highly specialised and it's unlikely someone in your company will have the ability to audit them or review the records (the auditor also needs to be qualified in the field). I think it's better to use an accredited lab for EMC if possible.

IEC 60601-1 tests are not that complicated, so it should be OK. The main problem with IEC 60601-1 is just that it's a huge standard to manage.

For IEC 60601-2-22, chances are your company will have more experience than the lab, so that should be fine. You could even prepare your own report in-house, again making sure to keep all the necessary background records.
 
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