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Dentallabnetwork.com
Outsourcing Concerns- FDA Regulations-ADA Regulati
FDA and outsourcing abroad (China)
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<blockquote data-quote="CoolHandLuke" data-source="post: 259241" data-attributes="member: 4850"><p>the short answer : its complicated</p><p></p><p>the long answer: its really complicated. every state abides by a different combinations of regulatory boards and commissions trying to get a handle on what can be done and what cannot be, and some of them do it for financial reasons, and some of them do it out of a sense of duty to the country... its hard to tell who is doing what and why. in some states its good that china sends work, because theres a shortage of capable, qualified, people. in some states there is a surplus. some patients drive out of state. some labs ship work out of state... its a mess of what should be regulated, who is actively regulating it, and why they actually care.</p><p></p><p>the fda controls certain aspects like who is allowed to make certain products, with what tools, and what materials. except in some states where a labour board or dental board would overturn that. the fda governs the products and such made in america; in order to qualify for that sticker you need to meet certain criterion.</p><p></p><p>canada has much the same idea but with a far simpler state of oversight, given we have only 11 conflicting provinces instead of 50 states with their own laws.</p><p></p><p>the fda requires makers of products (like medical devices) to be made with specific tools, to have a paperwork process in place that makes all the manufacturing secrets known. this is called a 510k. this must line up with the suggested manufacturing parameters laid out by a material manufacturer, such as Ivoclar, makers of e.Max who give guidelines as to the use of the material. if the two are in conflict, you do not get approval to make your product under your brand name.</p><p></p><p>so how to the chinese get away with sending cheap and inferior items? i urge you to consider, they are probably actually not made of tin cans and parts of rat bones. they probably do make them of approved, quality materials. thinking they arent is assuming malice where none exists. its in china's best interest to play by the rules after all. question their craftsmanship if you care, but its not likely the material is subpar.</p><p></p><p>people often wonder, how can china make a crown for 10-20 bucks? i cant buy an ingot for less than 30! well they can buy 10 million ingots and use them in a week. they have the buying power and get the breaks. buying 5 at a time is not worth giving you a break is it?</p></blockquote><p></p>
[QUOTE="CoolHandLuke, post: 259241, member: 4850"] the short answer : its complicated the long answer: its really complicated. every state abides by a different combinations of regulatory boards and commissions trying to get a handle on what can be done and what cannot be, and some of them do it for financial reasons, and some of them do it out of a sense of duty to the country... its hard to tell who is doing what and why. in some states its good that china sends work, because theres a shortage of capable, qualified, people. in some states there is a surplus. some patients drive out of state. some labs ship work out of state... its a mess of what should be regulated, who is actively regulating it, and why they actually care. the fda controls certain aspects like who is allowed to make certain products, with what tools, and what materials. except in some states where a labour board or dental board would overturn that. the fda governs the products and such made in america; in order to qualify for that sticker you need to meet certain criterion. canada has much the same idea but with a far simpler state of oversight, given we have only 11 conflicting provinces instead of 50 states with their own laws. the fda requires makers of products (like medical devices) to be made with specific tools, to have a paperwork process in place that makes all the manufacturing secrets known. this is called a 510k. this must line up with the suggested manufacturing parameters laid out by a material manufacturer, such as Ivoclar, makers of e.Max who give guidelines as to the use of the material. if the two are in conflict, you do not get approval to make your product under your brand name. so how to the chinese get away with sending cheap and inferior items? i urge you to consider, they are probably actually not made of tin cans and parts of rat bones. they probably do make them of approved, quality materials. thinking they arent is assuming malice where none exists. its in china's best interest to play by the rules after all. question their craftsmanship if you care, but its not likely the material is subpar. people often wonder, how can china make a crown for 10-20 bucks? i cant buy an ingot for less than 30! well they can buy 10 million ingots and use them in a week. they have the buying power and get the breaks. buying 5 at a time is not worth giving you a break is it? [/QUOTE]
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Outsourcing Concerns- FDA Regulations-ADA Regulati
FDA and outsourcing abroad (China)
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