Bioelectronics Corp (BIEL)

[DDGUY]

10/15/2015 FDA confirmed that it falls within the classification regulation that is the subject of the reclassification.

FREDERICK, MD. October 14, 2015 — BioElectronics Corporation (OTC Pink: BIEL), maker of consumer medical electronics products for pain management endorsed the U.S. Food and Drug Administration’s final rule 890.5290 on nonthermal pulsed shortwave devices published today in the Federal Register.

“I am pleased the agency has completed this step in streamlining the regulatory requirements for making available to Americans, the same safe drug-free pain relief option enjoyed in other countries around the world,” said Andrew J. Whelan, President. Earlier this year, in response to our request for information regarding the regulatory status of ActiPatch®, the FDA confirmed that it falls within the classification regulation that is the subject of the reclassification. We believe that the reclassification will contribute to an efficient review of our submitted evidence in our 510(k) premarket notification. The reclassification to Class II includes a provision for the FDA’s evaluation of our request for over-the-counter market clearance.

The Company is confident that the need for a safe, effective, and affordable drug-free treatment for chronic pain, without the dangers of narcotic and non-steroidal anti-inflammatory drugs, will further encourage swift FDA action.

Complete text of the FDA filing is available:
https://www.federalregister.gov/articles/2015/10/13/2015-25923/physical-medicine-devices-reclassification-of-shortwave-diathermy-for-all-other-uses-henceforth-to



About BioElectronics Corporation
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: ActiPatch® Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx® Devices for chronic and post-operative wound care; Allay® Menstrual Pain Therapy; and HealFast® Therapy for dogs, cats and horses. For more information, please visit www.bielcorp.com.

Contact:
BioElectronics
Paul Knopick
940.262.3584
[e-mail]