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The likelihood of approval by the FDA for a Class II Medical Device
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The likelihood of approval by the FDA for a Class II Medical Device
The likelihood of approval by the FDA for a Class II Medical Device
The likelihood of approval by the FDA for a Class II Medical Device
The likelihood of approval by the FDA for a Class II Medical Device
The likelihood of approval by the FDA for a Class II Medical Device
The likelihood of approval by the FDA for a Class II Medical Device
The likelihood of approval by the FDA for a Class II Medical Device
The likelihood of approval by the FDA for a Class II Medical Device
The likelihood of approval by the FDA for a Class II Medical Device
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class ii medical device, fda (food and drug administration), medical device registration
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  Post Number #9  
Old 13th August 2017, 07:10 PM
Ronen E

 
 
Total Posts: 3,358
Re: The likelihood of approval by the FDA for a Class II Medical Device

Please let me add that sometimes a 510(k) is "not cleared" not because there's a real problem with the device or because the FDA plays it hard, but because during the review process the submitter becomes aware of some missing piece (eg testing that needs completion, a change in marketing requirements as understood) and for various business reasons decides to abandon the submission. In such a case the time allocated by FDA for the submitter to respond might elapse, and the submission would be rejected on procedural grounds.

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