Dear Experts,
I have a major question with respect to equivalent devices. I have recently came across a report where they are preparing report for two subject devices and claiming equivalence using the same i.e, without considering other devices as equivalent. My question is can we consider subject devices as equivalent devices having different user group - one is pediatric, adult (>9kg) and the other one is only adult (>30 kg). Technological features are same but there is a bit difference in size. Can I consider subject devices as equivalent devices?
It would be great if you could list down the criteria to be considered for equivalent devices?
Thanks
I have a major question with respect to equivalent devices. I have recently came across a report where they are preparing report for two subject devices and claiming equivalence using the same i.e, without considering other devices as equivalent. My question is can we consider subject devices as equivalent devices having different user group - one is pediatric, adult (>9kg) and the other one is only adult (>30 kg). Technological features are same but there is a bit difference in size. Can I consider subject devices as equivalent devices?
It would be great if you could list down the criteria to be considered for equivalent devices?
Thanks