510(k) "received date" discrepancy


Diapason Consulting
Dear all,

I am currently facing an annoying problem and your insight woudl be highly appreciated.

I have a device (class II) which I have released (CE/ANZ) in 2010. It is an electronic diagnostic device, and had gone then through 60601-1 + -1-2 certification (test + NB review) under the 2nd edition.

I had obtained late 2013 some clinical validation data which were required for a 510(k) to have a chance to succeed (which I know thanks to a previously failed submission in 2010). Therefore, I have managed to put together a new 510(k) submission, aiming at the 31st december 2013 deadline for the acceptability of the 2nd edition of 60601.

We have called the CDRH beforehand to verify that the date of applicability of a standard is the date of submission, not the date of SE/NSE decision.

  • Our submission ("standard, no 3rd party") was received by the CDRH the 27th december.

  • We received a letter, date the 30th of decemeber, acknowledging that our submission had been received the 27th, and given the number K13XXXX, but that our e-copy was on hold due to an error in the e-copy as per the attachment. The attachment was an ambiguous and innacurate explanation of apparently two errors, the second being "The PDF files were not sequentially numbered starting with 001, with no two PDF files having the same number".
  • After several days (new year's day....) we managed to get the final confirmation that the two errors were actually only one single error: One file name contained an hyphen instead of an underscore :bonk::bonk:
  • We then submitted a new e-copy which was received and acknowledged the 6th of January, 2014. This new acknowledgement letter stated that the "date received" for our K13XXXX submission was the 6th of january 2014 :confused:

Of course, when our feedback came back, the reviewers were now saying that our declaration of conformance to 601 2nd edition was not receivable because the standard was obsoleted since the 31st of December, 2013 :mad::mad:

Has any of you ever encountered such difficulties ? Any advice on trying to defend our case?

Thanks in advance


Sometimes FDA is flexible; other times they are arbitrarily rigid, because it's the only way to cause a transition from one legal requirement to another to actually occur in a consistent way. My guess is that their institutional stance in this instance is the latter.
Top Bottom