We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
CDRH plans to reduce the number of IDEs requiring more than two cycles to make a determination by 25 percent by Sept. 30, and by 50 percent by June 30, 2015. The aim is to get the median time for full IDE approvals down to 30 days by June 30, 2015. Read More
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