"Calendar days from submission to FDA clearance â€
Post# of 11802
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Posted On: 07/18/2019 11:34:16 AM
Re: nonsequetor #7388
"Calendar days from submission to FDA clearance –
Traditional 510(k) only
Many industry veterans long for a return to the days when you could get a traditional 510(k) cleared within 100 days. It still happens, but
far less frequently than it did in the early 2000s. The FDA – like many other regulatory authorities - has become much more strict about
clinical evidence and testing requirements, thus lengthening the overall path to clearance. Most companies can plan on waiting about
six months to get the green light from FDA, although that varies by device (see page
. Companies willing and able to utilize Third Party
Reviewers can get to market about four months faster on average."
https://www.emergogroup.com/sites/default/fil...s-2017.pdf
Traditional 510(k) only
Many industry veterans long for a return to the days when you could get a traditional 510(k) cleared within 100 days. It still happens, but
far less frequently than it did in the early 2000s. The FDA – like many other regulatory authorities - has become much more strict about
clinical evidence and testing requirements, thus lengthening the overall path to clearance. Most companies can plan on waiting about
six months to get the green light from FDA, although that varies by device (see page
. Companies willing and able to utilize Third Party Reviewers can get to market about four months faster on average."
https://www.emergogroup.com/sites/default/fil...s-2017.pdf
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