M
Hi there,
I have a question about how one acquires data to demonstrate the substantial equivalence of your device to the chosen predicate.
This quote from the 510k statement:
" I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any ..."
found in the FDA software review document.
This would seem to indicate that by submitting a device for 510k approval you agree to provide the non commercially sensitive parts of that document to any company that requests it for use in their substantial equivalence submission.
Do i understand this correctly?
In which case the normal process would be to identify a suitable predicate device and then contact the company responsible with a request for their 510k submission data, minus commercially sensitive portions of course.
Also, why is this statement only necessary in statement and not a summary, does this have an impact on ones obligation to make the data available to a third party?
Many thanks
Mat
I have a question about how one acquires data to demonstrate the substantial equivalence of your device to the chosen predicate.
This quote from the 510k statement:
" I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any ..."
found in the FDA software review document.
This would seem to indicate that by submitting a device for 510k approval you agree to provide the non commercially sensitive parts of that document to any company that requests it for use in their substantial equivalence submission.
Do i understand this correctly?
In which case the normal process would be to identify a suitable predicate device and then contact the company responsible with a request for their 510k submission data, minus commercially sensitive portions of course.
Also, why is this statement only necessary in statement and not a summary, does this have an impact on ones obligation to make the data available to a third party?
Many thanks
Mat
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