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Dear AL Rosen & Atetsade,
Thank you for all your inputs.
I am aware that the advice from Atetsade was with reference to TENS device already listed/registered, however with the indication for pain control.
I also understand that there is no relevant predicate device to compare with to date based on my research on the FDA site, pertaining to the device i highlighted.
Basically the design and concept of the device is very simialr to a TENS device except for the intended use. We were wondering if anyone knows of an aternative route we could register the device with FDA if not through PMA. Considering the risk classification and device classification it does not seem justified for the device to be subjected to a PMA evaluation, just because its intended use is different. Does anyone have any experience with SECTION 513(F)(2) - Evaluation of Automatic Class III Designation, Guidance for Industry & CDRH Staff.
Thank you all for your advice. And AL, your kind advice is noted.
Thank you for all your inputs.
I am aware that the advice from Atetsade was with reference to TENS device already listed/registered, however with the indication for pain control.
I also understand that there is no relevant predicate device to compare with to date based on my research on the FDA site, pertaining to the device i highlighted.
Basically the design and concept of the device is very simialr to a TENS device except for the intended use. We were wondering if anyone knows of an aternative route we could register the device with FDA if not through PMA. Considering the risk classification and device classification it does not seem justified for the device to be subjected to a PMA evaluation, just because its intended use is different. Does anyone have any experience with SECTION 513(F)(2) - Evaluation of Automatic Class III Designation, Guidance for Industry & CDRH Staff.
Thank you all for your advice. And AL, your kind advice is noted.
but...