For the record, the legislated TGA Regs don't specifically call...

For the record, the legislated TGA Regs don't specifically call for multiple (three) batch tests of new devices as part of an Application. It seems that the TGA has used 'interpretive' powers to force this requirement, which is a fair enough request to ensure absolute public health safety.

However, in Rhythm's defence, impossible for them to know in advance to provide this data. In hindsight, it seems obvious of course, but my point is it's outside of the clear technical application guidelines. Very frustrating!

Therapeutic Goods (Medical Devices) Regulations 2002
https://www.legislation.gov.au/Details/F2023C00032