FREDERICK, Md., June 10, 2013 /PRNewswire/ — BioElectronics Corporation (OTC Pink: BIEL), the maker of advanced consumer medical devices, which has sold 500,000 devices, without prescriptions, in 57 countries reported that they have received three letters from the Office of Science Integrity. These letters are virtually identical in denying the firm’s request for the FDA Commissioner to review her staffs’ prior decisions. Dr. Jesse Goodman, Chief Scientist, said, “I have determined, in my discretion, that additional Agency consideration is not warranted” and simply suggested resubmitting 510(k) premarket notifications or “providing input into the recent CDRH process for reclassification of non-thermal shortwave diathermy devices.”
Andrew Whelan, President of BioElectronics said, “Despite the FDA’s egregious delays associated with applications initially filed in 2009, and our primary international business focus, we plan to continue to pursue all possible avenues to get OTC market clearance and bring to American consumers the same safe and affordable pain relief enjoyed by people around the world.”
About BioElectronics Corporation
BioElectronics (www.bielcorp.com) is an award winning developer and manufacturer of advanced medical devices. Its products are ActiPatch® Therapy, for over-the-counter treatment of back pain and other musculoskeletal ailments, the Allay™ Menstrual Cycle Pain Therapy, and RecoveryRx™ for surgical procedures and wound care.
SOURCE BioElectronics Corporation