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FDA 510K - Does the FDA accept the testing report from other countries?

R

Ruby2333

#1
Hi Guys,
my company is a manufacturer of medical devices in China. We're preparing submission for FDA 510K, and there are some uncertain problems:
Does the FDA accept the testing report from other countries,or is there any Requirements for testing Report or lab qualifications ?

Any guidance is highly appreciated.
:thanx:
 
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yodon

Staff member
Super Moderator
#2
That's a difficult question to answer.

If you're talking about bench testing and you have proper identification, control, and traceability of all the equipment and test materials; you have objective evidence to demonstrate the requirements are met; you can demonstrate all the other, related controls (protocols approved before use, protocols define acceptance criteria, tests traced to requirements and requirements fully tested, etc.); and there are no issues with data integrity (a hot topic at FDA these days) then the location where conducted probably isn't all that important.

If you're talking about tests for, say, compliance to 60601 then there are absolutely requirements for things like the environmental chambers that typically only a test lab would have and use of a non-accredited lab would probably be difficult to get accepted.

If you're talking about clinical studies (and since you're saying 510(k) I'm guessing this isn't a concern) then FDA has a guidance on what they would expect from a study done outside the US.

Your best bet is probably to engage with a Regulatory consultant that is experienced with non-US-made products getting cleared through FDA and letting that person give you advice on what is likely acceptable or not.
 
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