Question: A device that is based on existing approved technology -- a. must still go through the most rigorous approval process. b. will not be considered

  1. A device that is based on existing approved technology --

    a.

    must still go through the most rigorous approval process.
    b.

    will not be considered by the FDA in order to avoid patent violations.
    c.

    need not go through any FDA approval process.
    d.

    will be reviewed by the FDA as a Class II device, which will be less time consuming for the manufaturer.

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