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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="MaxHickey" data-source="post: 165624" data-attributes="member: 13149"><p>Approval of FDA (Food and Drug Administration) is essential for commercializing any medical device in the US market. Your <a href="http://www.ilexmedical.com/brands.php?act=cat" target="_blank">medical device</a> usually categorized in three different classes such as Class I, Class II and Class III. Here are the requirements for FDA submissions:</p><p>1. If your device comes under the Class I category, it is not necessary to wait for FDA clearance; however, you have to meet all Class I FDA product registration needs.</p><p>2. Device under Class II category will have to make a 510(k) submission for fulfilling FDA device registration needs.</p><p>3. Class III device, the FDA submission should have Pre-Sub (Pre-IDE) and IDE consulting.</p></blockquote><p></p>
[QUOTE="MaxHickey, post: 165624, member: 13149"] Approval of FDA (Food and Drug Administration) is essential for commercializing any medical device in the US market. Your [URL='http://www.ilexmedical.com/brands.php?act=cat']medical device[/URL] usually categorized in three different classes such as Class I, Class II and Class III. Here are the requirements for FDA submissions: 1. If your device comes under the Class I category, it is not necessary to wait for FDA clearance; however, you have to meet all Class I FDA product registration needs. 2. Device under Class II category will have to make a 510(k) submission for fulfilling FDA device registration needs. 3. Class III device, the FDA submission should have Pre-Sub (Pre-IDE) and IDE consulting. [/QUOTE]
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Outsourcing Concerns- FDA Regulations-ADA Regulati
New FDA Registration for Medical Device Manufacturers
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