Agree Clio.Here is the TGA info regarding class I, II and III...

Agree Clio.

Here is the TGA info regarding class I, II and III devices - https://www.tga.gov.au/products/medical-devices/medical-devices-overview

"The higher the potential risks of a medical device, the more they need to be examined and monitored. The level of risk that is identified determines: what type of evaluation the TGA needs to carry out the amount and type of information the TGA needs to review the degree of scrutiny necessary before the product can be made available in Australia."

Blood tests like Colostat are not mentioned, but they seem to fit into the level II risk category, which would not require ACMD consideration.
Reading through the lists of devices that were considered at the recent Feb ACMD meeting, there is a strong theme of implanted surgical-type devices, many concerning heart surgery. All are level III devices.

My thoughts are that specialised advisors have been engaged to assess Rhythm's application because it relates to mass population screening which is not an everyday type application, most likely outside of their regular assessments typology. I doubt they'd have experts on public health screening on staff.

The TGA is required to reach a decision before early May 2023 at the latest.