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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 will create a device-only enforcement unit that promises more consistent inspections and enforcement decisions with fewer bureaucratic hurdles for investigators to issue warning letters. Read More
In deciding to reorganize the Office of Compliance, CDRH made the pragmatic decision to focus its limited resources on encouraging quality rather than on compliance enforcements, OC Director Steve Silverman says. 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
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