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In a strongly worded position paper, the European Commission’s Medical Device Coordination Group (MDCG) has directed device manufacturers to get certified ASAP under the new device and diagnostics regulations. Read More
Leaks, breakage and other problems with plastic syringes manufactured in China have led the FDA to urge all users to check the manufacturing location of syringes and consider not using them while it considers preventing syringes made in China from entering the U.S. Read More
Over the past week, the FDA issued proposed rules to classify certain types of wound dressings and liquid wound washes containing antimicrobials and/or other chemicals and to require premarket approval applications for certain solid wound dressings; wound dressings formulated as a gel, cream, or ointment and liquid wound washes containing antimicrobials with a high level of antimicrobial resistance. Read More
Eitan Medical’s recall of 1,323 infusion pumps — for a risk that the pump may fail to detect air in the line when running on battery power — has been identified by the FDA as Class I, the most serious type of recall as use of these devices may cause serious injuries or death. Read More
Namandje Bumpus, currently chief scientist for the FDA, will replace Janet Woodcock as principal deputy commissioner, FDA Commissioner Robert Califf announced Wednesday. Read More
Despite overall enthusiasm for the use of multi-cancer diagnostic (MCD) tests, several members of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee raised concerns about the social and emotional risks the technology might carry. Read More
At an FDA advisory committee convened to gather insights on multi-cancer diagnostic (MCD) tests, the 10-member advisory panel veered off course when the topic of endpoints arose, voicing varying levels of support for mortality endpoints in trial design. Read More
The FDA is proposing to classify for the first time certain wound dressings and liquid wound washes containing antimicrobials or other chemicals, an action that would also mean a premarket application (PMA) would be required for some of them. Read More