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Dss 8655 Form

Dss 8655 Form

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in section 5 we'll dive into documentation first we'll look at some of the more common terms before moving on to the different versions of the 510k and their criteria will finally take a brief look at the PMA the fourth step in bringing your device to market in the US is the preparation and submission of your dossier there are many terms used throughout the regulatory industry and it's important to understand these terms for documentation purposes some of the more common ones include predicate device this is a medical device already legally marketed in the US selected for the purposes of substantial equivalence as part of the fda 510 K submission substantial equivalence indicates that the device has the same intended use as a device already marketed in the US and has similar technological characteristics of that device intended use refers to the objective intent for the labeling of the device the intent is determined by labeling claims advertising matter or oral

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