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AFE44xx in certified product ?

Dear T.I. team

please, is there any FDA certified product using any AFE44xx of T.I. and which product is it please ?

Best Regards

Jean

  • Hello Jean,

    We have received your inquiry regarding the AFE44xx family and hope to have some answers back to you soon.
  • Hi Jean, thank you for your question.  We treat all of our customers information as sensitive and propriatary - so unfortunatley, we cannot point you to a particiluar customer or end product. However, we can disclose that there are several customers going through the FDA approval process now that using several different products from the AFE44xx family of devices.

  • Dear Nichole Oljaca

    Ok thanks for your reply, but what is the best way to success with T.I. for FDA certification based on the best algorithms, hardware, and sensor ?
    My direct email is available for discussing.
    Best Regards
    Jp
  • Hi JP, as you may already understand, the FDA certification process is done at the system/end product level and not at the IC device level.  While TI makes quality IC devices, its up to our customers to navigate and comply with the complex requirements of FDA certification at the system level (which can vary greatly depending on the end use of the end product).

    If you are looking for suggestions on 3rd parties that can help with optical sensor design and algorithm support - we'll be very happy to make some suggestions. However, they also will not be experts on the specifics of FDA requirements or steps to certification.