Referring to previously submitted biocompatibility results in a new 510(k) submission

shimonv

Trusted Information Resource
#1
Hello Fellows,
Has anyone had experience with submitting a 510(k) application and referring to a biocompatibility test results which belongs to a previously approved submission of a similar product instead of submitting a new set of biocompatibility test results? This of course is based on the premise that there is 100% equivalence in the material selection and manufacturing method.

I can't see a reason why it should't go through, but I am curious to learn from other peoples experiences.

Thanks!
Shimon
 
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Asia78

Involved In Discussions
#2
Hi Shimon,
No your approach will not be acceptable to fda. You shall provide the test related to your device, no matter if another device had same material and compatibility tests, you have to prove that your device is safe
 
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