loanranger
7 hours ago
News??? Naaaa. Who would issue it?
Pressed rat and warthog have closed down their shop.
They didn't want to; 'twas all they had got.
Selling atonal apples, amplified heat,
And pressed rat's collection of doglegs and feet.
Sadly, they left, telling no one goodbye.
Pressed rat wore red jodhpurs, warthog a striped tie.
Between them, they carried a three-legged sack,
Went straight round the corner and never came back.
SitTight
3 days ago
The BeaMed 501(k) approval should be expected by the end of the year, not the end of this month or even September.
Your thought process is probably:
- On Track File 510(k) Submission to FDA in Q2 2024
- 90 days review
=> approval end Sept 24
But please read this insightful article: https://www.hardianhealth.com/insights/how-long-does-an-fda-510k-actually-take#:~:text=By%2090%20days%20(allowing%20for,510(k)%20decision%20letter
So… 90 days?
Not quite…would that it were so simple.
The 90 day timeline is the total calendar days that the FDA takes in reviewing your SaMD or AIaMD device application, NOT including any days while on hold waiting for you to respond. You will note above that you can be put on hold up to 180 days at various points in the process, mainly due to the FDA having further queries that you will need to put in work in order to satisfy. In fact, having a hold period is extremely common. So common that the FDA has a set limit on how long the total time to decision should take - and that’s 270 days - three times as long!
Total time to decision
To highlight how often the ‘90 day’ timeline is not achieved in practice due to extra holding periods, we analysed publicly available data from the FDA 510(k) database for the most recent submissions for the two SaMD product codes we deal with the most.
(image here)
We can see that the vast majority of 510(k) decisions are not made within 90 days. In fact, that’s the exception, not the rule. Only two SaMD products actually achieved that, and only for one product code. Most applications are bunched between 140-200 total days before a final SE decision is made.
So I personally do not expect any decision before the end of the year, although I'd appreciate to see it this Monday :)
But I fully do believe we will get the 501(k) approval, so far they have done everything as planned.