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Repacker/Relabeler (a/k/a/ Customer) is now shown as "Holder" of 510(k) in Database

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Old 27th December 2017, 04:23 AM

Total Posts: 40
Truce Repacker/Relabeler (a/k/a/ Customer) is now shown as "Holder" of 510(k) in Database

Hello all,

We are a medical glove manufacturer. In reviewing our 510(k)s in the 510(k) database, one of our customers is now shown as being the Holder of one of our 510(k)s. There are no facts or documents to support them as owning any of our 510(k)s - they also appear as the Holder of many major manufacturer 510(k)s which would simply not be the case.

I suspect that they should be using the MDLs that we have generated (as Spec Developer / Foreign Exporter), but have instead generated their own MDLs using our 510(k) numbers which would indicate to the FDA that they are the presumptive owner of the 510(k), which is then reflected in the 510(k) database automatically (or without meaningful review).

Has anyone encountered this before? Any advice on how to handle? The factory is climbing up the walls and management is looking to blame someone for "losing" one of our 510(k)s. All the while, we can't be aggressive with the customer.

I suspect they've hired someone new in RA who thought they were doing the correct thing and this is probably an innocent error. But nevertheless, we need to fix the problem and I'm not sure we can rely upon the Draft 510(k) Transfer of Ownership guidance (can't post the link yet due to post count) which states we can go to the FDA in case of a dispute over 510(k) ownership.

And everyone's on vacation ...

Happy Holidays to all and thank you in advance!

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