FDAnews Device Daily Bulletin

Industry’s case against significant reforms to the FDA’s policy on when devicemakers must submit a new 510(k), made during a Thursday public meeting, drew pushback from consumer groups that argued current controls don’t ensure patient safety.

The China Food and Drug Administration last month released a document outlining acceptance criteria for in vitro diagnostic reagents makers.

A medical expert argues that the Trans-Pacific Partnership contains little language about actual trade issues and more language promoting American corporate interests such as evergreening and deregulation.

A study published this month showed that patients widely support medical imaging for the diagnosis of illness.

Boston Scientific has enrolled its first patients in a U.S. trial of its Vercise deep brain stimulation device.

Delcath is being sued by investors after a negative FDA vote.

The Department of Homeland Security and the FDA have discovered that nearly 300 medical devices from 40 companies have password security problems.

A June article in the journal Circulation shows that overall health level may be a more important predictor of success with an implanted defibrillator than age.