FDA Status

BioElectronics Product Status with the FDA

October 14, 2015

BioElectronics Applauds the FDA’s Reclassification of Nonthermal Shortwave Therapy Devices

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


August 6, 2015

BioElectronics Files 510(k) Premarket Notification for ActiPatch® Therapy with FDA

We are pleased to announce we have filed a 510K Premarket Notification for ActiPatch® Therapy with the US Food and Drug Administration.

As most of you know, the FDA has not yet published the reclassification for pulsed shortwave from Class III to Class II as proposed in February of 2013. The mechanism of action of our device is different from traditional devices. We have filed a request for clarification to determine if we should continue to use the pulsed shortwave classification of our devices clarified, we have decided not to wait. We do not foresee adjusting or resubmitting the application to accommodate a different FDA action.

“I am pleased with the strength of this filing and confident that it will satisfy the agency staff,” said Andrew J. Whelan, President and CEO. “We felt the overwhelming nature of our evidence, the solid legal and regulatory support from the law firm of Goodwin Proctor, and the American consumers’ dire need for safe pain relief warranted filing. Our request for over-the-counter market clearance is strengthened by three clinical trials on ActiPatch use in osteoarthritis knees, plantar fasciitis and post-operative pain, our explanation of the mechanism of action, the overwhelmingly positive results of the recently published United Kingdom and Ireland Registry assessment of 5,000+ users, our surveys of users published this week in Pain Management, and the sale of hundreds of thousands of devices.

The extreme need for an effective, safe treatment for pain without the dangers of narcotics should move the FDA to a prompt and positive action.