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

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

Industry hopes that new Russian device regulations would speed up the pace of registrations and approvals have paled as regulators struggle to create implementing guidance. The regulations took effect in January 2013, but have yet to be fully enacted. Read More

The UK’s healthcare cost-benefit watchdog is recommending implantable cardioverter defibrillators as a first-line treatment for people with previous serious ventricular arrhythmia, those with a familial cardiac condition with a high risk of sudden death and patients who have undergone surgical repair of congenital heart disease. Read More

Devicemakers must include information on potential pediatric use in most new device submissions under a U.S. Food and Drug Administration final rule that takes effect April 10. Read More

Peruvian officials have opened the door to the importation of unregistered devices for certain provisional uses. Read More

Russian regulators are struggling to create guidance that will implement device registration rules that took effect in January 2013, but have yet to be fully enacted. Read More