The US Food and Drug Administration (FDA) has announced that members of its Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet on 18 February 2016 to provide advice and recommendations on clinical trial, post approval study design, and physician training requirements for leadless cardiac pacemaker device technology.
The meeting will be held in Gaithersburg, USA. Committee members, the FDA announced, will be asked to make recommendations on the acceptability of adverse event rates in acute and chronic timeframes as well as indications for use for this device type, given availability of other technologies with different adverse event profiles; required training and acceptability of observed learning curves for the new device type and necessary elements for post approval study collection.
Click here for more information on the FDA Advisory Committee meeting on leadless pacing.
