FDA Regulations and Medical Device Pathways to Market

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  • เผยแพร่เมื่อ 27 ก.ย. 2024

ความคิดเห็น • 11

  • @meenakshirana6467
    @meenakshirana6467 8 ปีที่แล้ว +1

    It's a very informative presentation. Thank you very much for uploading it.

  • @Elizabethterhune
    @Elizabethterhune 7 ปีที่แล้ว

    Great presentation, thank you! I used it to help study for my bioregulations exam. Super helpful.

  • @j.6946
    @j.6946 5 ปีที่แล้ว

    Great presentation, thanks so much. This is very helpful.

  • @MysterERaps
    @MysterERaps 4 ปีที่แล้ว +1

    I'm curious how 300k to a million for initial costs on a class 1 device breaks down, budget wise

  • @dennychoi4439
    @dennychoi4439 5 ปีที่แล้ว

    Great video ! thanks a lot

  • @saurabh5534
    @saurabh5534 6 ปีที่แล้ว

    In 510k, the product gets cleared by USFDA but you mentioned as approved? please clarify sir

  • @leeswanson2766
    @leeswanson2766 7 ปีที่แล้ว +1

    CFR = Code of Federal Regulations

    • @sptzk7133
      @sptzk7133 3 ปีที่แล้ว

      CFR does stand for code of federal regulations however the federal register or congressional federal registry he referred to seems to be the daily discussions of these laws and once they are finalized they are introduced into the CFR. So it seems it is reasonable to misspeak, I only look this up because I wasn’t sure if the lecture was credible, but looks like it is:)

  • @dianawright6975
    @dianawright6975 4 ปีที่แล้ว

    Can anyone have one

    • @dianawright6975
      @dianawright6975 4 ปีที่แล้ว

      For my own use. Plus listens for me. I do have medical problems.

    • @dianawright6975
      @dianawright6975 4 ปีที่แล้ว

      And cost