We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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.
Read More
The coalition urged the FDA to “explicitly state in the draft guidance that the CDER program applies to the device constituents of combination products under CDER jurisdiction.”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