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China’s National Health and Family Planning Commission plans to “blacklist” devicemakers convicted of bribing government officials and ban sales of their products for two years — four for repeat offenses. Read More
ArthroCare has agreed to pay a $30 million fine and enter into a deferred prosecution agreement to resolve a U.S. Department of Justice criminal investigation of stock price manipulation. Read More
Ocular Therapeutix’s ReSure Sealant kit won FDA approval last week, making it the gel for sealing small incisions in the eye after cataract surgery. Read More
CDRH is working on ways to allow devicemakers to use more adult clinical trial data in proving the safety and effectiveness of pediatric devices, center staff said Wednesday. Read More
The Central Drugs Standard Control Organization has issued detailed guidance on the registration, reregistration and import of notified in vitro diagnostic kits and on the import of non-notified kits, with the aim of speeding submission reviews and easing the move to electronic submissions. Read More