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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="KatieKosty" data-source="post: 83085" data-attributes="member: 6895"><p>I haven't seen this posted yet-new FDA requirements for Medical Device Establishments</p><p></p><p><a href="http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm314844.htm?source=govdelivery" target="_blank">Medical Device Establishment Registration and Listing - Notice of Changes for FY 2013</a></p><p></p><p>FDA Device Registration and Listing:</p><p></p><p><a href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm?source=govdelivery" target="_blank"></a></p><p><a href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm?source=govdelivery" target="_blank"></a></p><p><a href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm?source=govdelivery" target="_blank">If you're going to apply for a 510K, you should first apply for a Small Business Qualification-it will save 1/2 the cost for your first 510K:</a></p><p><a href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm?source=govdelivery" target="_blank"></a></p><p><a href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm?source=govdelivery" target="_blank">[URL="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/UCM314389.pdf?source=govdelivery"]http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/UCM314389.pdf?source=govdelivery </a></p></blockquote><p></p>
[QUOTE="KatieKosty, post: 83085, member: 6895"] I haven't seen this posted yet-new FDA requirements for Medical Device Establishments [url=http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm314844.htm?source=govdelivery]Medical Device Establishment Registration and Listing - Notice of Changes for FY 2013[/url] FDA Device Registration and Listing: [URL="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm?source=govdelivery"] If you're going to apply for a 510K, you should first apply for a Small Business Qualification-it will save 1/2 the cost for your first 510K: [URL="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/UCM314389.pdf?source=govdelivery"]http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/UCM314389.pdf?source=govdelivery [/URL] [/QUOTE]
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Outsourcing Concerns- FDA Regulations-ADA Regulati
New FDA Registration for Medical Device Manufacturers
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