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The pathway would “allow certain medical devices onto the market before manufacturers completely demonstrated the device’s safety and effectiveness,” the senators said. Read More
Four units in an unreleased lot were observed to have trace amounts of residual polishing compounds used in the needle sleeve manufacturing process. Read More
CDRH released a list of priority guidances it plans to publish during fiscal 2020, including numerous quality-related final and draft guidances. Read More
In a newly released guidance, the FDA spells out what manufacturers need to consider when labeling catheters, wires and delivery systems with lubricious coatings used during minimally invasive diagnostic and therapeutic vascular procedures. Read More