Public Advisory Panel Accepts FDA’s Class II Re-Classification Suggestion
FREDERICK, Md., May 23, 2013 /PRNewswire/ — BioElectronics Corporation (OTC Pink: BIEL), the maker of very effective, safe consumer medical devices, comments on the FDA panel meeting for non-thermal shortwave diathermy:
The FDA’s Public Advisory Panel Reclassification – Pulsed Shortwave Therapy Meeting was held on May 21, 2013 in Gaithersburg, MD, USA. The focus of the meeting was very narrow, in that the FDA had instructed the panel to focus solely on the application of non-thermal shortwave diathermy for the treatment of postoperative pain and edema and the treatment of edema following blepharoplasty. Industry representatives, including BioElectronics President Andy Whelan , presented a compelling case for reclassification. The recommendation from the FDA’s advisory panel was reclassification from Class III to Class II with special controls including a requirement for new clinical data. At this time it is not clear if the requirement for new clinical data applies to existing products. The FDA will make a final decision on the recommendations of the panel in due course, though BioElectronics believes that the FDA will follow the panel’s recommendations.
“Overall, we see the advisory panel and the FDA’s recommendations as a positive and potentially significant development,” stated Ian Rawe , BioElectronics Director of Clinical Research. “After decades of use and research, the FDA now believes that the available evidence suggests that shortwave devices can be safely regulated. If existing cleared devices are compelled to submit new clinical data, our 3rd Molar Extraction clinical study at Tufts Dental School, Boston, meets all the FDA’s clinical research standards. This study is evaluating both postoperative pain and edema, with edema being quantified with a 3D digital imaging system (http://www.3dmd.com/). Therefore, because of these expected developments and with expanded clinical research in place we are confident of moving forward.”
We also continue to press our Petitions in the FDA’s Commissioner’s Office of Science Integrity for our musculoskeletal and menstrual pain market clearances and we are optimistic that this reclassification concession will help expedite market clearances.
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.