Hi all, I would really appreciate some guidance on our existing 510(k) submission:
We have a pain management device (class IIa) with an approved 510(k). We now have non-randomized clinical data that shows that the device shows extended pain-relief and we would like to add this claim to our device. As far as I understand, this would require submitting a new 510(k). My questions are:
1) Is a new 510(k) the right approach and should our intent be change in effectiveness? Is there no way to modify an existing 510(k) to add a claim?
2) Does the FDA accept non-randomized (prospective) clinical study in cases like these (RCT was not unethical/unfeasible but simply more costly)? Existing 510(k) has 2 clinical tests with RCT data and we have other research data that supports our non-RCT data results. Is it even worth trying with a pre-submission?
Thanks so much! Any guidance is appreciated
We have a pain management device (class IIa) with an approved 510(k). We now have non-randomized clinical data that shows that the device shows extended pain-relief and we would like to add this claim to our device. As far as I understand, this would require submitting a new 510(k). My questions are:
1) Is a new 510(k) the right approach and should our intent be change in effectiveness? Is there no way to modify an existing 510(k) to add a claim?
2) Does the FDA accept non-randomized (prospective) clinical study in cases like these (RCT was not unethical/unfeasible but simply more costly)? Existing 510(k) has 2 clinical tests with RCT data and we have other research data that supports our non-RCT data results. Is it even worth trying with a pre-submission?
Thanks so much! Any guidance is appreciated
