The accessories will be sold in USA. They are similar to existing devices, except that the manufacturing process is slightly different to allow for a better fit. They will contact the face and the bridge of the nose for around a week. According to ISO 10993-1 specifications, these devices will be classified as surface devices, contacting the mucosal membrane, and as externally communicating devices to tissue/bone/dentin.
Since they are essentially similar to existing accessories and made with the same material (biocompatible silicone), do we need to perform all the tests marked in the ISO 10993-1 document?
I would take a less definitive approach than my peers here.
The answer to whether or not you can rely on the existing products depends on what
"the manufacturing process is slightly different" encompasses. If, as pointed, the existing products are yours, and you know what the differences are with 100% confidence, and those differences are of a certain nature (say, a small geometrical change in a molding tool) then perhaps you could justify not retesting.
If you do have to test, please note:
1. The FDA has a modified testing requirements matrix, based on ISO 10993 but not identical to it. Some additional tests might be required, based on various factors.
2. Since the change is (apparently) not big, you could perhaps suffice with (biocompatibility)
equivalence testing. This is a comparative testing that aims to establish that the 2 (different) designs are equivalent from a biocompatibility point of view. It is usually cheaper and easier that the full battery of tests required for a completely new device. The best would be to bring it up with your test lab.
Cheers,
Ronen.