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  • Writing Assignment #2

    Загружено:

    Vivek Bhat
    12 просмотров1 страница
    This document provides instructions for a writing assignment asking students to choose a medical device from the FDA's Classification Database, 510(k) Database, or PMA Database. In 3-5 pages, students must summarize the regulatory history of the chosen device, including its intended purpose, classification, time on the market, any changes or safety concerns like recalls, and potential future changes. The summary should cite where device information was found and can include the manufacturer's details if relevant. Key details to discuss are the device's classification, longevity, modifications, safety issues, and future outlook.

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    writing assignment

    Оригинальное название

    medical devices

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    © © All Rights Reserved

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    This document provides instructions for a writing assignment asking students to choose a medical device from the FDA's Classification Database, 510(k) Database, or PMA Database. In 3-5 pages, students must summarize the regulatory history of the chosen device, including its intended purpose, classification, time on the market, any changes or safety concerns like recalls, and potential future changes. The summary should cite where device information was found and can include the manufacturer's details if relevant. Key details to discuss are the device's classification, longevity, modifications, safety issues, and future outlook.

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    © All Rights Reserved
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    12 просмотров1 страница

    Writing Assignment #2

    Загружено:

    Vivek Bhat
    This document provides instructions for a writing assignment asking students to choose a medical device from the FDA's Classification Database, 510(k) Database, or PMA Database. In 3-5 pages, students must summarize the regulatory history of the chosen device, including its intended purpose, classification, time on the market, any changes or safety concerns like recalls, and potential future changes. The summary should cite where device information was found and can include the manufacturer's details if relevant. Key details to discuss are the device's classification, longevity, modifications, safety issues, and future outlook.

    Авторское право:

    © All Rights Reserved
    Скачайте в формате PDF, TXT или читайте онлайн в Scribd
    Отметить как неприемлемый контент
    из 1

    Writing Assignment #2

    Now that you know how to utilize the databases available to you on the FDA Website, use either the
    Classification Database, the 510(k) Database, or the PMA Database to choose a medical device that
    interests you.

    In 3-5 pages, describe (In Summary) the Regulatory History of this device. Think about some of the
    questions below when summarizing this history. Be sure to include why you chose this device, and
    describe where the device information came from either through description or citation (or both). Feel
    free to include brief information regarding the device’s manufacturer if you feel it is appropriate.

    Information to Consider

    • For what purpose is this device intended for?


    • Is this a combination product?
    • What Class of Device is this?
    • How long has this device been on the market?
    • Has the device undergone any major changes since it was first placed on the market?
    • Have there been any safety concerns with this device?
    o Recalls?
    o Withdrawals?
    o Legal Actions?
    • Is there any indication that this device will be undergo any major changes in the future?

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