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The agency now considers the definition of convenience kit “to mean a device that contains two or more difference medical devices packaged together and intended to remain packaged together.” Read More
CDRH released guidance on what information should be included in regulatory submissions for devices that generate quantitative imaging values. Read More
The FDA gave sponsors of combination drug/device products another year to get their IT affairs in order before complying with new postmarket safety reporting requirements. Read More
The guidance recommends that manufacturers place visible contraindications on their products regarding their use on tissues for which stapling is overly risky.
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