Hi everyone!
My device is a reusable stereotaxic screw for temporary fixation to the bone for surgical navigation.
It is made of stainless steel 630 and is provided non-sterile.
After reading FDA guidance, I'm still very confused what sterilization validation is needed. Is the reprocessing validation enough? Or should I provide a large sample size to validate the initial sterilization (this is what I learned from the lab)?
Somehow in my opinion the reprocessing validation is enough for the device, and I hope to avoid unnecessary tests. But I'm new to the industry worrying about making mistakes.
I would be grateful if anyone could help.
My device is a reusable stereotaxic screw for temporary fixation to the bone for surgical navigation.
It is made of stainless steel 630 and is provided non-sterile.
After reading FDA guidance, I'm still very confused what sterilization validation is needed. Is the reprocessing validation enough? Or should I provide a large sample size to validate the initial sterilization (this is what I learned from the lab)?
Somehow in my opinion the reprocessing validation is enough for the device, and I hope to avoid unnecessary tests. But I'm new to the industry worrying about making mistakes.
I would be grateful if anyone could help.