S
ssarangapani
Our company wants to apply to US FDA for an OTC classification of our Class II medical device. I have the following questions:
1. Should we submit a 510(k) application? - our device already has a 510(k) certification, but as a Class II device.
2. What if there was no other device of the same type in the OTC classification? Can we still apply and request to be considered for an OTC classification, even if there is no predicate device with OTC classification ?
3. Is there any guidance documents available from FDA on this subject?
Thanks,
Sarang
1. Should we submit a 510(k) application? - our device already has a 510(k) certification, but as a Class II device.
2. What if there was no other device of the same type in the OTC classification? Can we still apply and request to be considered for an OTC classification, even if there is no predicate device with OTC classification ?
3. Is there any guidance documents available from FDA on this subject?
Thanks,
Sarang