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Thanks caryS4 :) 510(k) Clearance to Market: The majority

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Ace508 Member Level  Saturday, 12/08/18 11:54:27 AM
Re: caryS4 post# 110215
Post # of 110265 
Thanks caryS4 :)

510(k) Clearance to Market:

The majority of Class II medical devices are cleared to market by submission and FDA review of a 510(k) Pre-Market Notification submission. The 510(k) submission identifies characteristics of the new or modified medical device as compared to a medical device with similar intended use, currently legally marketed in the United States. The currently legally marketed device is referred to as the “predicate” device.

Depending on the complexity of the new or modified medical device, the FDA Review of a 510(k) submission takes between 20 and 90+ days. The more complex the changes or comparison required to support the safety and effectiveness of the new or modified medical device, the longer the FDA review process.

http://www.qrasupport.com/FDA_MED_DEVICE.html


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