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Regulatory Roadblock?

Posted August 08, 2011 12:35 PM

The regulatory system in place in the U.S. is often touted as the foundation of patient and device safety. However, 76% of companies recently surveyed indicated that requirements for U.S. Food and Drug Administration's 510(k) product review process were unclear. The regulatory burden seems greater for small medical device and diagnostic companies: two-thirds are obtaining clearance for new products in Europe first. Product review time is twice as long in the U.S. as in Europe. What can be done to streamline the product approval process?

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Guru

Join Date: Mar 2011
Location: Sebastopol, California
Posts: 1205
Good Answers: 54
#1

Re: Regulatory Roadblock?

08/09/2011 11:22 AM

Here in the US the answer is simple. The powers not specifically enumerated to the Federal Government are reserved to the people....

We are going to be seeing a lot of trouble from federal regulations in the near future, not just for medical or medical devices. We are seeing it already with the FDA raiding farms! The people need to just ignore them and feed each other any way!

So, to that end, I'm working on a project here in Sebastopol to start a community soup kitchen twice a week in the park. I call it Stone Soup Gathering. The idea is simple, get the people together to eat, anyone, everyone, with what we have to offer, and make a big pot of soup and eat together. No non-profit organization. No FDA regulations. No federal mandates or money. Just gardeners and farmers and grocers and a hot pot of water.

This is what it will take to overcome the stupidity of regulators 3000mi away from reality! It's election time any way. What can they do if the local government and the local Sheriffs office are backing you up? They work for you, not the other way around. We have homeless families we didn't have before because our great benefactors and regulators have failed to protect their interests, such as a home and food. A regular Stone Soup Gathering can actually take care of that problem by solidifying the local community and the people themselves provide the solutions.

Health workers can, if they wish, provide free clinical services to those who need. People can get to know those who need face to face and perhaps solve rental problems and kill two birds. Anything is possible once the people get to gether and eat, talk, and communicate.

That's my two cents.

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Power-User

Join Date: Apr 2010
Location: Where no man should ever live
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#2

Re: Regulatory Roadblock?

08/09/2011 2:02 PM

In the construction trades it seems not only to be a regulatory problem but possibly pointing work toward preferred contractors and creating groups of people favored by the regulations.

It is nothing new, of course, but something we should assume our government would seek to eliminate.

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Guru

Join Date: Mar 2011
Location: Sebastopol, California
Posts: 1205
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#3
In reply to #2

Re: Regulatory Roadblock?

08/10/2011 10:19 AM

They will not eliminate the power they assumed they had. They will distribute the free money they get in whatever way they choose, no market forces at all, just their own "largess". Preferred contractors will always out do everyone else simply because they "play ball" with the guys with the Fed Bucks.

The reason this happens is because people have these two stupid notions:

1. "There ought to be a law..."

2. "The Government should do something...."

Those two thoughts lead straight to hell.

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Guru

Join Date: Apr 2009
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#5
In reply to #2

Re: Regulatory Roadblock?

09/14/2011 10:18 AM

Quite the contrary. Our (current) government seeks to malign the free enterprise system (which by the way creates most of the jobs) with regulation, and favors groups like unions with laws and regulations like Davis-Bacon. This is the primary reason companies are opening plants overseas; to escape the regulatory and tax burden of our government.

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08/14/2011 11:33 AM

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#6

Re: Regulatory Roadblock?

07/22/2012 2:24 PM

I would suspect that organizations like WHO and doctors without borders use patients in third world countries as test guinea pigs for new drugs and treatments before the FDA gives approval. I'm just an ordinary citizen, and not privy to "inside" information. Obviously it would be the first thing a researcher would consider, whether it is done or not.

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