Hello all,
I am trying to understand what parameters are included in performance specification besides the ones mentioned in FDA guidance document. FDA Guidance document Deciding When to Submit a 510(k) for a Change to an Existing Device lists performance specification as performance characteristics of a device as listed in device labeling or in finished product release specifications. Some examples of performance specifications are measurement accuracy, output accuracy, energy output level, and stability criteria.
Does performance specification include output voltage and output currents as well? Can you call specification of a device performance specification?
I tried searching the web but did not get a satisfactory answer. If you could point me to the right direction it will be highly appreciated.
Thank you.
I am trying to understand what parameters are included in performance specification besides the ones mentioned in FDA guidance document. FDA Guidance document Deciding When to Submit a 510(k) for a Change to an Existing Device lists performance specification as performance characteristics of a device as listed in device labeling or in finished product release specifications. Some examples of performance specifications are measurement accuracy, output accuracy, energy output level, and stability criteria.
Does performance specification include output voltage and output currents as well? Can you call specification of a device performance specification?
I tried searching the web but did not get a satisfactory answer. If you could point me to the right direction it will be highly appreciated.
Thank you.