BioElectronics Corp., a maker of inexpensive, disposable drug- free anti-inflammatory devices, announced it filed an application with the U.S. Food and Drug Administration (FDA) for reclassification to Class II of its existing device which was given FDA Class III approval in 2002. Additionally, based on information provided during a recent meeting with FDA personnel, the Company will also be filing an application for Pre-Marketing Approval (PMA).
BioElectronics said that reclassification will help facilitate over-the-counter (OTC) clearance in United States of its ActiPatch and Allay products. BioElectronics products Breitling Replica Watches are currently cleared for sale in dozens of countries including Canada, China, Japan, Korea and Australia. BioElectronics devices also have the CE Mark (European Common Market) certification for OTC sales and have been approved by Health Canada. BioElectronics' devices are currently considered thermal pulsed electromagnetic field (PEMF) therapy devices, but additional evidence shows the devices do not produce heat and should be classified as non-thermal devices.
"We have assembled a substantial amount of compelling documentation to present to FDA that outlines not only the extreme safety of our products, but also the high level of efficacy," said Andrew Whelan, CEO of BioElectronics. "Our products have been Cartier Replica Watches used by hundreds of thousands of individuals worldwide without a single safety complaint. The vast majority of these users had enjoyed substantial pain relief and decreased recovery intervals after injury or surgery. Thousands of others have received pain relief and accelerated healing of chronic musculoskeletal complaints. We have also completed and have several ongoing Institutional Review Board (IRB) supervised clinical studies sponsored by prominent physicians, which has clearly demonstrated the high efficacy of our products. We believe the examiners at FDA will be impressed by the compelling case we will present to them seeking reclassification. We strongly believe our products are Class II devices, which should receive OTC clearance in order to help the millions of American pain sufferers who are seeking pain relief and alternatives to potentially dangerous OTC drugs such as acetaminophen and ibuprofen."
"We believe Omega Replica Watches there are significant benefits to our Company and its shareholders to have our devices cleared via the PMA process as it effectively allows us to define a completely new space within the medical device and pain management markets," Whelan said. "Clearance under PMA will also allow us to better control our trade secrets and would prevent any would-be competitor from using our device as a predicate in order to receive clearance, ultimately making it much more difficult for anyone to compete with us in the domestic market place. We plan to immediately begin the PMA clearance process while our other applications run in parallel."
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