Home Free?.....Not So Fast

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While 510k is exempt GMP (Good Manufacturing Practices) regulatory requirement under 21 CFR 820 is not exempt and still need to be fully complied with. 

GMP

https://en.wikipedia.org/wiki/Good_manufacturing_practice

GMP Regulations

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ucm230127.htm

Remember I am not a lawyer but I hold an honorary JD from the University of Street Smart Chicago.

Now who is bullying whom?

   Now who is bullying whom?     

   Just the facts, ma’am.  

This post was removed from the Denture Living Forum site by its biased draconian moderator whose action caused to lose some of the other worthy contributors in disgust.

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                          Now who is bullying whom?  Just the facts, ma’am.

FDA Registered? The FDA doesn't say so.

FDA Registered? The FDA doesn't say so.

Cushion Grip alternative products have been long existed...If you only look - Case Closed!

Petition drive to Bayer?  Appeal to AG?  Investigate by Chicago Tribune reporter? 
Do all you like but what for?  Those viable CG equivalent or better products by major Japanese pharmaceutical companies are available today for anyone who wants to try.  All can be ordered perfectly legally by click of a mouse and delivered to your door step within a week or so. Many are already doing it and all have positive reviews. 

A little background

Last November 2015, a new post about Japanese cushion grip like product was posted on the Denture Living forum site first time and the Comfort Lining’s owner Jennifer Watson immediately begun attacking the post and its poster vehemently together with a few of her corroborating cantankerous termagants on the forum site. What is it that she and her shills have to attack so viciously on what appears to be any other useful piece of information posted by one of the new forum members? It turned out to be a Pandora’s Box of her own.

 Here's a list of CG alternative products vs Comfort Lining

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Open Pandra's Box - This is how it's all started

In last November 2015, Jennifer Watson first posted about her Cushion Grip replacement product on Denture Living forum site. She was offering free sample for anyone who wants to try it. Shortly after, there's a post about Japanese cushion grip like product posted on the same forum site. Jennifer immediately begun attacking the post and its poster vehemently together with a few of her corroborating cantankerous termagants on the forum site. What is it that she and her shills have to attack so viciously on what appears to be any other piece of information posted by one of the new forum members. I am piqued thus my gumshowing on Comfort Lining begun.

 “Avoiding careless attack on other can prevent disaster falling on oneself.”  
This rings all the more true here. In other words, this is a self-induced disaster.

This is what Jennifer Watson has publicly stated on the forum site so far:

Picking a fight with the poster - Initial attacks

•  ....trying to scam people or just writing nonsense          Groundless accusation/attack
•  It looks like a fake e-mail address that spammers use   Valid and active address

• I have patented a new product...                     No patent exists, period
• All natural and safe....                                     It's just her words and no proof
• Comfort Lining INC                                         No incorporation record exists
• Checked by the FDA                                       What check? 
• Comfort Lining is not considered, under the FDA     The FDA doesn't say so