Discontinuation of the Predicate Medical Device

#1
Hello,

we are currently working on a 510(k) submission of a class II medical device. Our new product is based on a predicate device from 2009. After successful submission of the 510(k) we would like to discontinue the predicate device immediately and no longer sell it.

Is this possible or could there be problems with the discontinuation?


Thank you.
 
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#2
Hello,

we are currently working on a 510(k) submission of a class II medical device. Our new product is based on a predicate device from 2009. After successful submission of the 510(k) we would like to discontinue the predicate device immediately and no longer sell it.

Is this possible or could there be problems with the discontinuation?


Thank you.
No issues I can think of ATM.
There is no requirement that a predicate be in active circulation, even at the time of submission, unless it was discontinued due to the discovery of serious safety/effectiveness problems.
 
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