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Hello,
We are preparing a 510k submission for class IIa medical device. System contains pc-sw and sensor which is used acquisition of biosignals.System does not provide any automatic analysis or diagnoses.
We have done all the documentation for pc-sw according to FDA guidance. But we are little bit lost with the firmware documentation in submission.
Where we should descripe firmware and firmware design documentation? In section 011 Device Description or in 016 Software Description?
Thanks for all the help.
We are preparing a 510k submission for class IIa medical device. System contains pc-sw and sensor which is used acquisition of biosignals.System does not provide any automatic analysis or diagnoses.
We have done all the documentation for pc-sw according to FDA guidance. But we are little bit lost with the firmware documentation in submission.
Where we should descripe firmware and firmware design documentation? In section 011 Device Description or in 016 Software Description?
Thanks for all the help.