The FDA’s second-in-command Joshua Sharfstein is stepping down as principal deputy commissioner to become Maryland’s secretary of health and mental hygiene, according to

FDA regulations dictating informed consent requirements for drug and medical device clinical trials are set to change on March 7, 2012.

The US Food and Drug Administration (FDA) has cleared two mobile applications for use as medical devices, potentially answering broader industry questions about how the regulator would view such products as they become more frequently used for health care-related purposes.

The US Food and Drug Administration’s Neurological Devices Advisory Committee came out last week in support of further testing of devices used in electroconvulsive therapy (ECT). ECT devices used i

A new study sponsored by the US medical device industry trade association Advanced Medical Technology Association (AdvaMed), “EU Medical Device Approval Safety Assessment,” has found that the European regulatory system has performed just as effectively in terms of public safety as the US Food and Drug Administration while simultaneously providing a speedier and more efficient path to market for manufacturers.

Manufacturers of automated external defibrillators (AEDs) will likely have to begin submitting premarket approval (PMA) applications for their products in the US based on rumblings at the Food and Dru

On the heels of revealing some of its 510(k) reform plans on January 19, the...

The US Food and Drug Administration (FDA) has rolled out the 510(k) premarket notification process...

The US Food and Drug Administration (FDA) has rolled out some — but not all — long-awaited changes to its 510(k) premarket notification process for clearing moderate-risk medical devices.

The US Food and Drug Administration (FDA) has recently published a draft guidance, “Electronic Source...