Bioelectronics Corp (BIEL)

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coachpappy33 • 13 hours ago

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Andrews response to my FDA related questions

I asked about naming actiband as the predicate device( which despite some incorrect discussion claiming you cannot name the predicate device because that info is sealed), here is his response to that and other question so;
ActiBand name was changed to Actipatch. The device is the same device for which has US FDA market clearance for the treatment of edema after blepharoplasty. We also have clinical studies and user documentation of its safety and effectiveness.

The FDA’s reclassification has simplified the path to market clearance. They have also included in the regulations the option for the over-the-counter classification.

Prior to the new regulations being published, we had submitted a De novo reclassification request based on our unique mechanism of action to which the FDA responded that it was necessary. We then submitted a new 510(k) market clearance application. To date we have not had any request for additional information or questions. Our application for market clearance is sound with 3 clinical studies, a copy of our published 5,000+ user response and a 50 consumer Usability Study showing that our directions-for-use are well understood by consumers.

Regards,

Andy
Andrew J. Whelan, President
BioElectronics Corporation Less