USB Cable (an accessory to our data management software) Changes and 510k

S

Silvertabb

#1
Hi
USB Cable is an accessory to our data management software. This cable has undergone some mior changes and the change was documented under Letter to File. I am working on filing a 510k for a data management system which was previous cleared under another 510k. There are cumulative changes now and as a result of that I need to do this filing. In addition to some changes in the data management software (to show the software is compatible with the new Microsoft operating systems), the USB cable driver was update and got certified by Microsoft.

Questions:

1) My understanding is that I don't need to include USB Cables change documentation processed under the Letter to File because they were minor. If this is true, it is required to provide a summary of the letter to file to show history of change OR I just need to leave it out altogether.

2) For the USB driver update, do I need to include the full V&V documentation or just a summary of V&V work in the 510k?

Thanks
 
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Peter Selvey

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#3
For a device covered by a 510(k), the regulatory requirement for reporting changes can be found at:

21 CFR 807.81(a)(3)

There is also a fairly old but apparently current guidance explaining the meaning of "significant".

Looking at the Flowchart B in the guidance, it would seem unlikely that upgrades to a USB cable would be reportable, but you should review the guidance and confirm for yourself.
 
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