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The International Medical Device Regulators Forum released final guidance that lays out procedures for sharing confidential postmarket surveillance for medical devices among regulators. Read More
Sharing information collected by medical devices with patients “may assist them in becoming more engaged with their healthcare providers in making sound medical decisions,” the FDA said in guidance for device manufacturers. Read More
The FDA proposed a framework for a voluntary pilot program aimed at using industry assessments of manufacturing quality to reduce the agency’s oversight actions. Read More