FDA 101 for Medical Devices

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  • Опубліковано 25 січ 2025

КОМЕНТАРІ • 15

  • @madmadderson7318
    @madmadderson7318 4 роки тому +2

    My favorite thing about FDA medical devices is the radiation emitting products applications. Cant wait for IoT...

  • @GermanShepherdDaphne
    @GermanShepherdDaphne 4 роки тому

    Where would one find the 510 K for a similar device??

  • @dareenrose6550
    @dareenrose6550 2 роки тому

    Thanks for the video, I have using NightRider cgm and Libre sensor for monitor the glucose values on phone without scanning and finger prick. Also, I share glucose data as well as my food insights, activity data to my endo. I found all these features are very useful.

  • @williamhui6195
    @williamhui6195 3 роки тому

    We found our N95 respirator can be registered as FDA product code MSH in FDA database with no 510(k) is needed. Once we got the establishment number issued by FDA, we can only use FDA registered for our N95 respirator. However, why we cannot declare our N95 respirators as FDA cleared? How should we do if we want to be FDA cleared eventually?

  • @jakeshkumar
    @jakeshkumar 4 роки тому

    I have doubt , does home use spoon (stainless steel) comes under FDA classification device 1or 2????
    Or is considered in FDA classification

  • @GermanShepherdDaphne
    @GermanShepherdDaphne 4 роки тому +1

    It's hard to understand

  • @baekyeonultraprecisionnkl9574
    @baekyeonultraprecisionnkl9574 3 роки тому

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  • @mokar0873
    @mokar0873 5 років тому +2

    Are these items considered as medical device?
    Dental resins
    3D scanners for dental laboratories
    3D printers
    Milling machines?
    How de classify them
    Thank you so much

  • @kpa-vo4pb
    @kpa-vo4pb 5 років тому

    What ear cleaning products are FDA approved by them .? Recommended

  • @TennesseetsychampsGriner
    @TennesseetsychampsGriner 5 років тому

    I need to no hoo can I talk to if illegal devices or being used on me

  • @sonandpets1215
    @sonandpets1215 2 роки тому

    Smart but it's very annoying to hear the lips smacking