Risks and challenges
In terms of manufacturing and shipping, there may be delays as with all things. That being said, we are using custom machinery to infuse the material with current pad specifications. A problem previously arose while making our sample batch causing the machines to get jammed due to the particles of our material being too small. We have since then fixed that and we don't expect to see it happening again. However unlikely, we still need to mention the possibility of manufacturing delays.
Shipping should be no problem either, however there is still always a chance of issues with shipping. We hope you will understand the challenges we may face, however slim that chance may be.
Another obstacle TOM will be facing is the determination of which classification the FDA puts us under. If we go through the 513(g) process and become labeled as a Class I medical device, which we believe will be the case, we will be ready to bring the product to market!
If however, they deem us as a Class II medical device for whatever reason, we will have to go through a more intensive testing process with clinical studies. We are not accounting for the cost of the clinical studies into our campaign as those prices are unpredictable and could reach astronomical numbers far reaching what we are currently able to afford. I'd like to thank everyone ahead of time for contributing to this cause. If funding surpasses our goal, the extra funds will help us fast-track to get through this process.
As we attempt to go through the FDA process, we are not able to claim that the rewards you will be receiving as a FDA-cleared product.
However, through our own rigorous testing, we know that it is completely safe, effective, and ready for use. By agreeing to back our project, you agree that: the choice of what you do with your product is up to you, therefore, we CAN NOT be held liable for ANY damages our products may cause.
When this project is successfully funded, you WILL be put as our priority and receive the promised products as soon as possible! Thank you for your support!
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