FREDERICK, Md., May 10, 2016 /PRNewswire/ — BioElectronics Corporation (OTC Pink: BIEL), the maker of advanced medical devices, announced that it remains in negotiations with the U.S. Food and Drug Administration (“FDA”) regarding its 510(k) premarket notification for the ActiPatch® Musculoskeletal Pain Therapy. Two weeks ago, it submitted detailed responses to the FDA’s questions related to the published clinical trials and the Company’s Registry Study of the 5,000 UK ActiPatch users. “We responded to all of the FDA’s questions from its review of our 510(k) submission and we are hopeful that we satisfied the agency’s inquiries,” said Ian Rawe, Ph.D., Director of Research for BioElectronics.
Last week the Company, through its lawyers, responded to the FDA’s concerns associated with the correct pathway for gaining an OTC status. Currently there are no legally marketed nonthermal shortwave therapy devices indicated for OTC use and thus the Agency believes the 510(k) route is inappropriate. However, it is the Company’s position that our submission provides the necessary evidence that the product is both safe and effective and that the FDA has found a number of proposed OTC labeled devices substantially equivalent to prescription devices. Consequently, the Company is scheduling a meeting with the agency regarding its current classification position and is maintaining its pursuit of an OTC indication for use for treatment of musculoskeletal pain.