WEBVTT

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How do you publish content
that stays compliant?

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One wrong word in a press
release can travel much further

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than your correction.

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Start with the exact words.

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A 510(k) device is FDA cleared.

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A De Novo device is granted.

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A PMA device is approved.

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And registered never means approved.

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Mistakes are common.

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In press releases that
said FDA registered,

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142 of 151 cited no
premarket decision at all.

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Then claim only the use
your clearance covers,

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back every claim with evidence,

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and have regulatory review
it before it goes out.

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Start with three things.

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One: keep a list of approved wording.

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Two: check every claim
against your clearance.

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Three: correct old releases
and distributor pages too.

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Compliant content is credible content.
