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Dentallabnetwork.com
Outsourcing Concerns- FDA Regulations-ADA Regulati
New FDA Registration for Medical Device Manufacturers
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<blockquote data-quote="designasmile" data-source="post: 83423" data-attributes="member: 892"><p>From an email </p><p></p><p> I have seen that information from Mary and from the FDA site. But, be careful, that is old information based on the statement that there is NO FEE for registering as an initial importer. That changed as of July, and requires the lab to pay $2575. No exemptions for labs that must register. </p><p></p><p> </p><p></p><p>From my investigation, and communication with the FDA, NADL, and Customs, the only labs that won’t have to register are labs that make basic dental products domestically i.e. crowns, bridges, dentures. IF they import, make sleep apnea appliances, or anything Class II they will be obligated to register AND pay. And as far as offshore…the offshore lab is now required to provide the FDA with their customer list, which then goes into the data base, and no one can hide from the long arm of the law!</p></blockquote><p></p>
[QUOTE="designasmile, post: 83423, member: 892"] From an email I have seen that information from Mary and from the FDA site. But, be careful, that is old information based on the statement that there is NO FEE for registering as an initial importer. That changed as of July, and requires the lab to pay $2575. No exemptions for labs that must register. From my investigation, and communication with the FDA, NADL, and Customs, the only labs that won’t have to register are labs that make basic dental products domestically i.e. crowns, bridges, dentures. IF they import, make sleep apnea appliances, or anything Class II they will be obligated to register AND pay. And as far as offshore…the offshore lab is now required to provide the FDA with their customer list, which then goes into the data base, and no one can hide from the long arm of the law! [/QUOTE]
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Outsourcing Concerns- FDA Regulations-ADA Regulati
New FDA Registration for Medical Device Manufacturers
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