What is an FDA US Agent? And why do you need one?

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  • เผยแพร่เมื่อ 29 ม.ค. 2025

ความคิดเห็น • 27

  • @evantumminello3283
    @evantumminello3283 หลายเดือนก่อน +2

    Great video! This was very clear and concise and strengthened what I already knew and fleshed out several details I was not aware of.

    • @MedicalDeviceAcademy
      @MedicalDeviceAcademy  13 วันที่ผ่านมา

      We strive to make the complicated regulations easy to understand. I'm glad you found it clear and concise.

  • @KayKay-ts8qm
    @KayKay-ts8qm 4 หลายเดือนก่อน +2

    Good educational Info, becca will soon reach you.

    • @MedicalDeviceAcademy
      @MedicalDeviceAcademy  4 หลายเดือนก่อน +1

      Thank you. Looking forward to working with you.

  • @davidjia-c7r
    @davidjia-c7r 7 หลายเดือนก่อน +1

    Haha, I am here to practice my listening English. Think you Sir, It's really helpful.

    • @MedicalDeviceAcademy
      @MedicalDeviceAcademy  7 หลายเดือนก่อน

      That's a very clever idea. I speak quickly and there is a lot of technical jargon. It must be quite a challenge, but this will prepare you well for communicating with English-speaking auditors, inspectors, and other medical device professionals.

  • @moshemelamed4808
    @moshemelamed4808 11 หลายเดือนก่อน +2

    Hey, I think that a good SBOM tutorial or prep for video conference would be amazing

    • @MedicalDeviceAcademy
      @MedicalDeviceAcademy  11 หลายเดือนก่อน +1

      Very good suggestion. Thank you. I am presenting a live webinar on 510k software documentation requirements on March 7, 2024, and a webinar on cybersecurity documentation on March 18, 2024. Our cybersecurity work instruction (i.e., WI-007) includes a template for an SBOM. The March 18 webinar will include a brief tutorial on how to use that template and the March 7 webinar will show you how and where to attach the SBOM template once you complete it.

  • @bgbhat
    @bgbhat ปีที่แล้ว +1

    thank you sir, this has been very useful

  • @1Himalayansoul
    @1Himalayansoul 9 หลายเดือนก่อน +1

    Thank You Sir for the info.

  • @MosheMelamed-j4w
    @MosheMelamed-j4w 11 หลายเดือนก่อน +1

    Hey, I love your videos

    • @MedicalDeviceAcademy
      @MedicalDeviceAcademy  11 หลายเดือนก่อน

      Thank you. If you have any suggestions for a future video, we love your ideas.

    • @moshemelamed4808
      @moshemelamed4808 11 หลายเดือนก่อน

      @@MedicalDeviceAcademy see above

  • @canataol9726
    @canataol9726 ปีที่แล้ว +1

    Thank you :)

  • @anthonyt6160
    @anthonyt6160 8 หลายเดือนก่อน +1

    Is the us agent responsible if something legal happens with the foreign company?

    • @MedicalDeviceAcademy
      @MedicalDeviceAcademy  8 หลายเดือนก่อน

      The US agent is responsible for communications between the FDA and the company. If the company is not cooperating with the FDA in the event of a recall, then the US agent will need to assist the FDA with a recall. I have never seen this happen, but it could. The US agent does not have any control over the company. Therefore, the US agent can't be liable for things the company does.

  • @pinkflaminggo3797
    @pinkflaminggo3797 ปีที่แล้ว +1

    I would like more info

  • @eduardoippolito2152
    @eduardoippolito2152 ปีที่แล้ว +2

    • @MedicalDeviceAcademy
      @MedicalDeviceAcademy  ปีที่แล้ว

      No it is not required to have a DUNS number to become a US Agent if you are in the USA.

  • @RuchaPatel-x1j
    @RuchaPatel-x1j ปีที่แล้ว +1

    Does US Agent have to be independent of the registration facility? Can an employee of foreign establishment residing in US be a US Agent?

    • @MedicalDeviceAcademy
      @MedicalDeviceAcademy  ปีที่แล้ว

      A US Agent can be associated with the facility being registered (e.g., a US sales representative) or they can be independent (e.g., a consultant). In either case, the person must reside int he USA. Therefore, yes an employee of a foreign establishment residing in the US can be a US Agent.

  • @darritchonvincent5842
    @darritchonvincent5842 2 หลายเดือนก่อน

    Hello, are you an agent? I need to renew my FDA registration, can you help me?

    • @MedicalDeviceAcademy
      @MedicalDeviceAcademy  2 หลายเดือนก่อน

      Yes, we offer US Agent services. You can visit our contact us page to request a copy of our US Agent agreement:
      medicaldeviceacademy.com/contact-us/
      Or visit our website specific to those services: fda-us-agent.com/