R
Hi,
I work at a manufacturer of standalone medical device software. We have to submit a 510(k). My questions are:
1. FDA states the "510(k) holder/submitter" must sign the Truthful and Accuracy Statement. FDA defines 510(k) holder as the "owner" of the 510(k) submission. Who, by position or authority is typically the "holder"? Executive Management? Company owner? Quality Manager? Product Manager?
2. Is there any other part of the 510(k) submission that must be signed by the "holder"?
Thanks
I work at a manufacturer of standalone medical device software. We have to submit a 510(k). My questions are:
1. FDA states the "510(k) holder/submitter" must sign the Truthful and Accuracy Statement. FDA defines 510(k) holder as the "owner" of the 510(k) submission. Who, by position or authority is typically the "holder"? Executive Management? Company owner? Quality Manager? Product Manager?
2. Is there any other part of the 510(k) submission that must be signed by the "holder"?
Thanks