On December 20, 2021 the FDA Released their Recognition List Number 057 through their online db. With that publication of list 057 two, EMC IVD standards were added to the list.
But the FDA only Partially Recognized IEC 61326-1:2020 and IEC 61326-2-6:2020.
What does that mean to IVD EMC tests?
We have done a detailed analysis that has been confirmed by FDA’s EMC experts to let you know what EMC tests you need to conduct in order to meet both FDA and EU requirements for IVD equipment.
If you have IVD devices that you are submitting to the FDA you will need to be aware of these requirements. Rely on our experts for this analysis. We have had discussions with the FDA to understand the issues so we can explain this information.
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