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A Groveland, Fla.-based company has been taken to task by the FDA for a number of problems at its facility, including failure to identify actions to prevent recurrence of nonconforming products. Read More
CDRH soon will have three medical device divisions that are responsible for monitoring and managing the entire establishment inventory both domestically and globally, under its new program alignment. Read More
A new report from the Duke-Margolis Center for Health Policy is offering an initial peek into a planned coordinating center intended to guide the development and implementation of a postmarket device evaluation system. Read More
With an eye toward making the conduct of clinical studies more efficient, the FDA and NIH have unveiled a template intended for investigators writing Phase 2 or 3 trial protocols that require IDE applications. Read More
Two House members are calling on HHS Secretary Sylvia Burwell to provide more details of how the department is responding to the Zika outbreak, saying the current status of diagnostic testing for the virus is alarming. Read More