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ElmerF
Hello all,
Just wondering if anyone has experience with this. We want to introduce a new brochure for our customers for a medical device. It does not contain any information that was not in our original 510K submitted to FDA but we did not submit any marketing literature with our 510K. Following when to submit a new 510K labelling section there are no new containdications, no change to Indications, warnings or precautions.
Does it require a 510K or a note to file?
Any input appreciated,
Thanks, ElmerF
Just wondering if anyone has experience with this. We want to introduce a new brochure for our customers for a medical device. It does not contain any information that was not in our original 510K submitted to FDA but we did not submit any marketing literature with our 510K. Following when to submit a new 510K labelling section there are no new containdications, no change to Indications, warnings or precautions.
Does it require a 510K or a note to file?
Any input appreciated,
Thanks, ElmerF
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