BioElectronics Product Status with the FDA
– Last FDA status update: 5-22-14
The comment period for the FDA proposed rule (Docket No. FDA-2012-N-0378) closed on Wednesday, May 21. BioElectronics Corporation has submitted its official response supporting the reclassification to Class II and additionally presenting arguments for OTC allowance as part of that comment. The FDA will now review the comments. We continue to focus on our efforts on completing our clinical trials and assembling the data we will file as soon as the FDA announces the new rules.
We continue to develop our markets outside the US and educate consumers and the medical community inside the US. As part of our ongoing outreach and education program, an interview with a member of our medical advisory board, Dr. William Van der Reis, is appearing in an upcoming issue of Becker’s Review, a leading orthopedic journal and on last Saturday he was interviewed about how he’s using BioElectronics products on sports injuries in his practice on an ESPN radio show, WeekEnd Warriors, which you can hear here starting at 19:26 into the program. The show is hosted by another orthopedic surgeon, Dr. Robert Klapper, who has invited Dr. van der Reis back to continue the discussion.