If you are planning your biocompatibility testing for a 510(k) or De Novo submission, we have 3 tips:
1) follow the FDA 2023 guidance and not the standard, because the FDA deviates from the standard
2) if your device only has intact skin contact, then review Attachment G before you select your materials; this may help you avoid testing altogether
3) fill in the FDA eSTAR prior to requesting a quote, because that will help you request quotes for the correct testing endpoints and the correct extraction conditions

If you are interested in learning more about the FDA guidance on biocompatibility, we are conducting a live webinar on February 29, 2024.

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