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The FDA’s Center for Devices and Radiological Health is working on ways to permit sponsors to use more adult clinical trial data in proving the safety and effectiveness of pediatric medical devices. Read More
The IRB at a major Chicago hospital has been handed an FDA warning letter for a slew of violations in a device clinical trial, many of which were first observed at the site over a decade ago. Read More
Sponsors conducting clinical trials in India must fully inform study patients about potential payments resulting from adverse events during videotaped informed consent sessions, a draft guideline says. Read More
New device registries should only be launched if they are the least burdensome way to meet scientific objectives, AdvaMed says in a revised document on registry principles released Tuesday. Read More
Devicemakers should note whether changes to PMA devices were due to enhancement, product complaints or adverse events when preparing annual reports for the FDA, new guidance released Friday says. Read More
Young children with diabetes have a new treatment option, thanks to the FDA’s approval of the Dexcom G4 Platinum continuous glucose monitoring system for children as young as two. Read More