How to handle 510(K) submisison in 2014 when the Fees were paid in FY13 ?

[TheEnginerd]

We paid our 510k fee in FY13 ($4960) and then submitted in FY14. I just got a hold letter from the FDA saying they're holding the submission until we pay the fee. Does anyone have guidance on the process for this?
1) Can we just pay the extra $210 and be good to go? or
2) Do we need to get refunded our original $4960 and then submit a new $5170 user fee and get a new MD###?

Just wondered if this had happened to anyone else before, and what they did about it.

 

[MIREGMGR]

Re: 510(k) Fee Paid in FY13, 510(k) submitted in FY14

Interesting. I would have thought that once you had your payment code, you were good to go. Apparently not.

I'd ask DSMICA for a pointer to where the relevant rule is, and how to proceed.

 

[TheEnginerd]

Re: 510(k) Fee Paid in FY13, 510(k) submitted in FY14

Well, I heard back. DSMICA forwarded my query to the User Fees folks and they replied that basically our $4960 was trapped in FY13 and we had to submit a Transfer Request to get it moved to FY14 so it could be applied to the 510(k). Then we just pay another $210 to make up the difference and generate a new User Fee Cover Sheet.

Very bizarre that user fees can be trapped in time...

 

[ReliantVa]

It'd best to pay FDA fees just before you're ready to submit your 510k or 513g. The fees you pay are only useful for the fiscal year in which the submission is made. (thus you cannot pay fees now hoping get to save money on higher fees if you plan to submit in a later year.)