ESTAR 510(k) submission question

M Knight

Registered
Hi All!
We are in the process of preparing a 510(K) submission to add MR conditional labeling to the our Class II product. We also are using eSTAR to prepare the submission. Given that MR labeling changes have to be a traditional submission as opposed to a special we ran into a unique situation with the eSTAR format.

My question is:
Using eSTAR, do we still need to complete the sections for "Reprocessing, sterility and shelf-life" and "Biocompatibility" of the form? Since its just a labeling change to an existing system my preference is to leave them N/A but the eSTAR format doesn't make that clear its an option.
 
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