This message was posted by a user wishing to remain anonymous
Hi,
Is there any particular requirement by the FDA, EU MDR, Health Canada for joint arthroplasty devices to have direct clinical studies with more than 200 implants per study in lieu of demonstrating substantial equivalence?
Data for substantial equivalence is unavailable. However there are various level (II-IV) of direct clinical study is available with more than 150 implants per study. This is apparently not meeting the benchmark of 200 implants per study for the Australian TGA. Also, can't find where in the TGA regulations or the guidance 200 implant per study has been specified.
These devices are available in the US since 2011 and in EU since 2016. More than 30000 implants have been sold globally since 2011. These devices are also included in the UK NJR and NZJR data.
Any pointers in the US FDA, EU MDR and Health Canada documents regarding this 200 implants per study benchmark will be helpful.
Thank you.