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Impact on 510(k) to use an additional manufacture

#1
We currently have clearance for a class II product in the US. This is manufactured by a 3rd party outside of the US. We are now looking to use an additional manufacture also outside of the US to manufacture the same product to meet increased market demand. The product is sold worldwide and also has a CE mark (class IIa (ns)

The product will have the same SAP code and the labeling will be the same with the exception of the made in statement for the two manufacturing sites

The only difference is that the current product has a five year shelf life and we want to launch the product from the second manufacture ASAP and will only have accelerated shelf life data to provide a 2 year shelf life

Can anyone help to point me in the direction of if this will impact the current 510(k) or any other key areas to consider when considering launching a dual source product?

TIA
 
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