RegulatoryUS_EU
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dear friends,
we are sending this message related to the eSTAR submission
A 510k was submitted to the FDA using the eSTAR template. The company recieved the list of deficiencies via email and now the company would like to asnwer to this deficiencies
May I request your advice on the best way to proceed. How can the company respond to the deficiencies? provide the answers via ecopy? or should we provide a new eSTAR with the updated sections?
thanks
we are sending this message related to the eSTAR submission
A 510k was submitted to the FDA using the eSTAR template. The company recieved the list of deficiencies via email and now the company would like to asnwer to this deficiencies
May I request your advice on the best way to proceed. How can the company respond to the deficiencies? provide the answers via ecopy? or should we provide a new eSTAR with the updated sections?
thanks
