from a Hint of Halite Productions…in conjunction with a Speck of NaCl…
Do you have a new product or medical device?
Is it defective “with the potential for life-threatening or serious, permanent harm“?
We can still bring it to market!
If you can prove that it is similar to an existing product, we can fast track it using the 510(k) review process!
NOW SHOWING at a HOSPITAL NEAR YOU…
THE 510(K) FAST TRACK REVIEW PROCESS!
LIFE AT FULL THROTTLE!
FAST-TRACKED DEFECTIVE DEVICES!
Now here is the good news!
- There is NO human testing required on your device!
- There is NO manufacturing plant inspections required on your device!
From the article:
“National Research Center for Women & Families looked at medical devices recalled from 2005 to 2009 for defects with the potential for life-threatening or serious, permanent harm. They found 80 out of 113 recalled products, or 71 percent, were cleared through a shorter FDA review process known as 510(K) that was designed for low- and moderate-risk devices. The faster review allows approval if a device is similar to another on the market. The FDA usually does not require human testing or manufacturing plant inspections. Most new devices are cleared through that process.”
This is great news! I was devastated when my brand new product failed it’s review because it is defective, has been recalled and has the potential for life-threatening or serious, permanent harm! I put so much time and money into it’s development. Your fast track review process is a life saver (yes, I know, an ironic, morbid and bad joke). Please submit my device for review under the 510(k) process as I think you will find that my device is “similar to another on the market.” In fact, it is similar for the following reasons:
- It has been recalled, so it is specifically similar to “80 out of 113 recalled products, or 71 percent” that have also been recalled.
- It is similar due to it’s being defective like so many defective devices you have approved.
- It is similar because it has the potential to be life-threatening.
- It is similar because it can cause serious, permanent harm.
I think you will have no recourse other to agree that my new device is similar and should be accepted and reviewed under 510(k) process. When it passes despite the potential for harm that it will almost definitely fulfill, as I’m sure it will, there will be even one more similarity!
Defective…but now still marketable!
Do you know why there is no fast track approval process for adult stem cell treatments? Because adult stem cell treatments are unique in that they can not prove any similarity to pre-existing defective and life threatening devices. Here is why adult stem cells just don’t get along with pre-exiting drugs, products and devices; here is the true “problem” with adult stem cells…
- They treat 130+ DISEASES around the world
- They have a 60-80% SUCCESS RATE typical therapeutic benefit
- There are RIGOROUSLY ASSESSED & SCRUTINIZED treatment centers
- There are POTENTIAL CURES of Autism, Parkinson’s, AIDs, Diabetes, Heart Disease and more
- They provide HUGE REWARDS of life extension
- They provide SIGNIFICANTLY IMPROVED quality of life
There is not ONE pre-existing product, drug, device or treatment that can claim this.
Adult stem cells are incredibly unique, like a snowflake, so…no fast track review process. Sorry guys!
But if it makes you feel any better, your choices of brand new and improved defective or life threatening products and devices that do slightly different things from previous defective or life threatening products and devices seem to be increasing in leaps and bounds! This SUV comes in red, blue, green and now….black and silver! Hooray!