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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
The FDA called for feedback on a newly released report on biological responses to metal implants and said it’s investigating possible adverse events linked to the devices. Read More
Becton, Dickinson has entered into an agreement with the state of Georgia to settle litigation by the state’s Attorney General aimed at temporarily stopping BD from operating its Covington medical device sterilization facility. Read More
The European Medicines Agency released a new question and answers document on its Medical Devices Regulation and In Vitro Diagnostic Regulation in an attempt to answer mounting questions from industry. Read More
The A-list draft guidance for the year ahead include guidances on breast implants, premarket submissions for managing cybersecurity and distinguishing between device servicing and remanufacturing. Read More