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The FDA has updated its eSTAR online medical device 510(k) application submission process — which became mandatory as of Oct. 1 — to include additional submission types. Read More
Cordis’s recall of Infiniti angiographic catheters for lack of sterilization has been identified by the FDA as a Class I recall, the most serious type of recall as use of these devices may cause serious injuries or death. Read More
AdvaMed, a trade group for medical devicemakers, did not submit a public comment but instead issued a statement on the subject in late September. Read More
Recalled glucose capsules marketed as a health supplement for blood glucose control were found to contain glyburide and metformin — drugs that treat type 2 diabetes by lowering blood sugar — were deemed a Class I recall by the FDA, the most serious type of recall as use may cause serious injuries or death. Read More
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
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