Ann: Update to TGA Submission, page-148

I agree that Rhythm should have thought of it, but wanted to make the point that neither the Regs or Legislation specifically call for multiple batch testing as part of the application process. There are certainly plenty of requirements legislated to batch test once a device is listed on the ARTAG and in use.

Do you know how many separate device batches the other company you mention have tested and compared for consistency? Sounds like they just ordered a single large batch, but I could be wrong because I haven't researched it.

There is of course a difference between sample testing within a single large batch, and cross checking consistency across multiple batches.