Dear all,
I'm a new member and I'm looking for your help!
My product is a spinal cage, a device that will be implanted in bone for more than 30 days. It will be in a composite material with PLA (resorbable). So I should perform the following test:
- cytotoxicity
- sensilization
- irritation
- systemic toxicity
- subacute and subcronic toxicity
- genotoxicity
- implantation
- chronic toxicity
- carcinogenicity
- biodegradation.
The company that will manufacture the cage for my company has already obtained the approval for the CE mark for a cage in the same composite (they will manufacture my cage also in the same way). However this cage has a different shape and different size compared with my cage (in particular it is smaller than mine).
In your opinion I could skip out some tests exploiting the likeness with this cage or not? I know that one could in general follow the "literature route" ...
Thanks for all the help you'll give me.

Rossella

Try to get an agreement with the manufacturer to supply those documents and adopt them into your TF.

Thanks for the above reply. I have a similar question as well.

We are developing an ear dome with a thermoplastic vulcanate (TPV) and a double coated plastic tape. Both the materials are compliant with ISO 10993 part 5 and 10. We are not changing the properties of the materials being used in the final product.

We are thinking of going the literature route as well according to ISO 10993 part 1.

We have contacted biological testing labs as well and these insist that a biological test should be carried out on the whole finished product. The test is quite expensive and takes over 8 weeks.
I will appreciate, if some one who is dealing with biological testing on products on a regular basis can give me some recommendation.

Thanks

There are three reasons for why you might perform lab testing

1) You can't demonstrate the safety of your product without it

2) Your legal / regulatory people consider the cost to be irrelevant in building a watertight legal defense

3) External regulators require the testing, regardless of your ability to make the case via other means.



When I review this kind of thing I am looking for a few things.

a) absolute confirmation that the material being used is the one that has previously been shown to be safe and effective. "No complaints to date" is often a weak argument, would adverse reactions be identified as being the results of bio-incompatibility, and would they be properly routed through the complaints system?

b) Absolute confirmation that no further contaminants are added during the subsequent manufacturing processes. This can often be very hard to demonstrate.

c) the (previous/literature) demonstration of bio-compatibility matches what ISO 10993 expects to be demonstrated. Sometimes not all the "boxes" can be ticked.