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Dentallabnetwork.com
Outsourcing Concerns- FDA Regulations-ADA Regulati
FDA and outsourcing abroad (China)
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<blockquote data-quote="JMN" data-source="post: 259242" data-attributes="member: 8469"><p>State boards cannot overturn fda regs, they can however be more strict.</p><p></p><p>The crazyness with US law and regulation is due to all 50 states retaining measures of soverienity, providing they do so within the framework of the constitution, this is in part what the 10th ammendment is about. Each state (or commonwealth) can and do make decisions for themselves regarding many things, including trade delegations that go to other countries, and accept trade delegations from other countries as well.</p><p></p><p>China has a great track record on their products being made properly and from the right materials. Who wouldn't want milk tainted with a human harming chemical to make it test as higher in protein, or wallboard/sheetrock that off-gases formaldhyde.</p><p></p><p>Not every business or lab there, by far, has inferior materials, inferior methods, inferior equipment, or undertrained staff that will result in a poor restoration or prosthetic. But I think you would agree that something outsourced to China has a greater chance of issues than were it sent to Belgium, Sweeden, Germany, France,...</p><p></p><p>As to the materials, the ones we use are certainly available, but so are pirate versions. Flexite for some time had a warning that the "flesite materials" being sold on eBay are knock-offs. Fake chips (silicon) are rampant.</p><p></p><p>It *is* insulting to think all of the Chinese labs are acting in bad faith. It's also insulting when they *do* act in bad faith.</p><p></p><p>Someone here told a story of getting an account by putting a magnet to a China outsource crown, and the crown stuck.</p><p></p><p>The part I cannot fathom is how it works out cheaper after the shipping costs. Not duties and tarrifs, just the UPS bill alone, adds a not insignificant layer of cost.</p><p></p><p>China has some amazing options ahead with enormous oppourtunities. If you are 1 in a million over there, there's 999 of you. We should stay aware.</p></blockquote><p></p>
[QUOTE="JMN, post: 259242, member: 8469"] State boards cannot overturn fda regs, they can however be more strict. The crazyness with US law and regulation is due to all 50 states retaining measures of soverienity, providing they do so within the framework of the constitution, this is in part what the 10th ammendment is about. Each state (or commonwealth) can and do make decisions for themselves regarding many things, including trade delegations that go to other countries, and accept trade delegations from other countries as well. China has a great track record on their products being made properly and from the right materials. Who wouldn't want milk tainted with a human harming chemical to make it test as higher in protein, or wallboard/sheetrock that off-gases formaldhyde. Not every business or lab there, by far, has inferior materials, inferior methods, inferior equipment, or undertrained staff that will result in a poor restoration or prosthetic. But I think you would agree that something outsourced to China has a greater chance of issues than were it sent to Belgium, Sweeden, Germany, France,... As to the materials, the ones we use are certainly available, but so are pirate versions. Flexite for some time had a warning that the "flesite materials" being sold on eBay are knock-offs. Fake chips (silicon) are rampant. It *is* insulting to think all of the Chinese labs are acting in bad faith. It's also insulting when they *do* act in bad faith. Someone here told a story of getting an account by putting a magnet to a China outsource crown, and the crown stuck. The part I cannot fathom is how it works out cheaper after the shipping costs. Not duties and tarrifs, just the UPS bill alone, adds a not insignificant layer of cost. China has some amazing options ahead with enormous oppourtunities. If you are 1 in a million over there, there's 999 of you. We should stay aware. [/QUOTE]
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Outsourcing Concerns- FDA Regulations-ADA Regulati
FDA and outsourcing abroad (China)
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