Change predicate device

[Watsonregmd]

Hi all,

just wanted to ask which is the procedure to change a predicate device as part of a 510k clearance. Can the original predicate be replaced for another device? can we add a new predicate or reference device on top of the original predicate device that was used?

Which will be the procedure to conduct these changes?

thanks a lot!
WC

 

[EmiliaBedelia]

Hi all,

just wanted to ask which is the procedure to change a predicate device as part of a 510k clearance. Can the original predicate be replaced for another device? can we add a new predicate or reference device on top of the original predicate device that was used?

Which will be the procedure to conduct these changes?

thanks a lot!
WC

1) this is not relevant to CE marking, you should post in the US FDA regulations forum.
2) The procedure to modify something that you have previously submitted in a 510k is to submit a new 510k. If you are making a change to the product that could impact the safety and effectiveness (per the FDA's guidance), you need to submit a new 510k. You don't need to submit a 510k if you have not modified the device - there is no reason to change the predicate just for its own sake. Each 510k is 'self contained' and stands on its own. It's not a 'living document' and does not need to be maintained in the same way that the CE mark technical file is.

You can select whatever predicate is most appropriate, even if it is different from the original 510k. The objective of any 510k is to compare the subject device against a predicate, so regardless of what predicate you choose you still have to submit the same body of evidence and make the same comparison to another marketed device. You should only use 1 predicate, and reference devices should only be used if you really need to incorporate a particular technological aspect.