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Devicemakers should start thinking about restructuring their quality system away from the quality system inspection technique toward the medical device single audit program. Read More
Wayne, Pa.-based Teleflex is recalling 47,140 units of its Arrow International intra-aortic balloon pump catheters and percutaneous insertion kits following reports of serious adverse events. Read More
Chester, N.Y.-based Repro-Med, a manufacturer of infusion pumps and intravascular administration sets, has earned an FDA warning letter for failures involving quality systems and medical device reporting, as well as other violations. Read More
An FDA warning letter takes SureTek Medical to task for its procedures related to assessing contamination for reprocessed single-use devices. Read More
Newly released government data shows the FDA has been conducting more quality systems inspections at foreign devicemakers to keep up with rapidly growing inventory at those manufacturers. Read More
CDRH soon will have three medical device divisions that are responsible for monitoring and managing the entire establishment inventory both domestically and globally, under its new program alignment. Read More