FDA 510(k) Payment requirements for a Small Company

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!
 
I

isoalchemist

No good idea's. The FDA has enough problems keeping thing straight with payments under normal conditions.
 
A

ascherp

We are consultants and have submitted many small business applications for our clients over the last few years. It is true that the FDA website establishes a turnaround time of 8 weeks, but our experience has been that it actually takes much less time if the forms are complete at the time of submission. Record time for the FDA to assign a small business number was five business days after receipt of the application and it has never taken more than two weeks.

Belasting may be more of a problem for you... Good luck!
 
A

Anoniem

Thank you both for your response, I appreciate that. We decided to just continue the official procedure and keep our fingers crossed for a quick procedure!
 
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