A
Anoniem
We are a small medical device company in the Netherlands. We want to start selling our devices around October this year in the USA.
Our 510(k) is finally finished for the major part of our products, composing this was a lot of work. It is boxed and ready for shipment.
I wanted to ship it and do the payment, so they receive the payment and the box at the same time, as is written on the FDA website.
Then I saw this:
FDA will not accept reduced fees without a Small Business Decision number and will not refund the difference between the standard fee and the small business fee after the submission has been received.
That Small Busines Decision number will take us max 6 weeks locally and 8 weeks for FDA, this is 2,5 months delay in our planning. :mg:
Except from paying the standard fee ($5,170 instead of $2,585), does anybody have a bright idea to speed this up?
I also want to warn other new small companies, organise this number before writing that 510(k)! FDA helpdesk has no other solution.
Thank you very much for your comments!
Our 510(k) is finally finished for the major part of our products, composing this was a lot of work. It is boxed and ready for shipment.
I wanted to ship it and do the payment, so they receive the payment and the box at the same time, as is written on the FDA website.
Then I saw this:
FDA will not accept reduced fees without a Small Business Decision number and will not refund the difference between the standard fee and the small business fee after the submission has been received.
That Small Busines Decision number will take us max 6 weeks locally and 8 weeks for FDA, this is 2,5 months delay in our planning. :mg:
Except from paying the standard fee ($5,170 instead of $2,585), does anybody have a bright idea to speed this up?
I also want to warn other new small companies, organise this number before writing that 510(k)! FDA helpdesk has no other solution.
Thank you very much for your comments!