Replies to post #43146 on Bioelectronics Corp (BIEL)

[seven-up]

This was added to the Docket on 10/7/14

Comment from Spexell Pharma.

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This is a Comment on the Food and Drug Administration (FDA) Proposed Rule: Physical Medicine Devices; Reclassification and Renaming of Shortwave Diathermy for All Other Uses

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CommentView document:
To Whom It May Concern:
In response to FDA requesting comments on its technical correction proposal to reclassify SWD and non-thermal SWT devices to Class II designation, Spexell Pharma ("Spexell") wishes to support the FDA proposal in full.

It would appear that the devices in the subject category present no known issues with respect to adverse short-term or long-term side-effects, while providing users an alternate efficacious management to current Rx and OTC chemical based pain management and soft tissue healing options. Spexell has tested the ActiPatch line of products manufactured by BioElectronics Corporation and found them to be of high material quality and fully conforming to all representations as to both treatments of various sources of pain and efficacy.

Spexell has extensive experience in the dermatology field branded and generic pharmaceuticals related thereto and in particular with LightStim products and understands the advantages of maintaining a drug-free environment, wherever possible, in treating skin and soft tissue pain and regeneration issues.

http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-0378-0055

[seven-up]

Can you fit it in your schedule to attend? Wonder if anyone from Biel will attend. If you cannot make it maybe you could script something for Jimzin or someone to present. Jimzin could take some of the world's best yam vodka Covington Vodka with him and pass around... that way he could write it off as business trip.. LOL a bottle with a Actipatch wrapped around it.......

[seven-up]

What do you think is up with them adding to the Docket on 10/7/14, wonder if we are fixing to see a release? Someone is working on it.....

[lizanne1890]

thanks Simpsonly, I am ready to moved forward,go biel!

[JustGarden]

Simpsonly, An interesting item in the Federal Register.

After reading the comments from the gov regulations, I am concerned that they don't bode well for Biel, especially the one from the National Center for Health Research. They were really negative. Plus two of the others were critical of the time frame to submit 510's. What's your take on this?