ETF128 Registered as Class I Device with FDA

A regulatory affairs consultant was contracted to provide guidance on the most appropriate pathway to pursue with the FDA for the ETF.  Our consultant’s  report, citing two key predicate devices, concluded that we were on very solid ground registering as a Class I device exempt from 510(k) approval. This was welcome news as there would have been significant time and money spent jumping through the 510(k) “hoop”.