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Mechanical Test Under FDA Freedom of Information Act

#1
Good Morning everybody,

I need to request some mechanical test results to make a side-by-side comparison between a predicate device and my subject device which I'm seeking clearance through a 510(k).

The doubt is if this kind of information could be released under a FOI request or not? If not, how would I know if the predicate mechanical properties are equivalent my subject device?
 
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yodon

Staff member
Super Moderator
#2
Even if so, it may take months to get it.

*Sometimes* if you go to the device product code on the FDA site, you can see the relevant standards. Sometimes test labs can identify appropriate tests. I hear presubs are getting hard to come by but if you can arrange one and propose your testing strategy, they may indicate where it falls short.
 

pziemlewicz

Involved In Discussions
#3
Depending on device type the easiest route is usually to order one and test the two side-by-side. If there is specific materials info you're looking for, you can send the predicate to a lab for analysis.

FOIA takes forever and device-specific test data is very often redacted.
 
#4
Even if so, it may take months to get it.

*Sometimes* if you go to the device product code on the FDA site, you can see the relevant standards. Sometimes test labs can identify appropriate tests. I hear presubs are getting hard to come by but if you can arrange one and propose your testing strategy, they may indicate where it falls short.
Thanks for the answer!

So, maybe I can send my test results in a Pre-Sub and ask to FDA if it is equivalent to the identified predicate? So they can compare? Is that right?
 
#5
Depending on device type the easiest route is usually to order one and test the two side-by-side. If there is specific materials info you're looking for, you can send the predicate to a lab for analysis.

FOIA takes forever and device-specific test data is very often redacted.
Thank you for the attention, but in our case, it is not feasible to buy a predicate component to make the tests.
 
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