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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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The coalition urged the FDA to “explicitly state in the draft guidance that the CDER program applies to the device constituents of combination products under CDER jurisdiction.” Read More