Which biocompatibility tests do you need to do for a 510(k)?

This video is specific to the FDA requirements for devices that you submit a 510(k) submission. Even though the FDA recognizes the ISO 10993-1 standard, the biocompatibility testing requirements for CE Marking devices are different.

[@rohanpawar1621]

How would you classify the duration of contact for a medical device used to store blood and blood components cryogenically (for 30 days or more) but comes into contact with the patient for less than 24 hours? According to ISO 10993-1, what would be the duration of contact classification for this scenario?

[@MedicalDeviceAcademy]

Blood and blood components are not something that you can remove once you infuse them into the body. Whatever chemicals were extracted or leached into the blood and blood components will remain in the blood once you infuse it--even though the IV bag may only be connected to the patient for minutes. Therefore, the testing for demonstrating biocompatibility should be evaluated for the long-term endpoints instead of the limited duration endpoints. It is also recommended to review the biological evaluation plan with the regulator in advance, because the storage environment is unique and may result in a very different extraction of chemicals from the bag than room temperature storage. I would expect regulators to look for evidence of how the risk of cryopreservation has been addressed--in addition to the endpoints listed in ISO 10993-1.

[@erenyeager3377]

Hello sir I have question

[@MedicalDeviceAcademy]

How can I help you?