Center for Devices and Radiological Health (CDRH) director Jeffery Shuren has advocated rejection of 510(k) clearances in instances where applicants’ predicate devices have undergone safety recalls .

New guidance from the US Food and Drug Administration spells out how medical device manufacturers and study sponsors should format

New informed consent requirements for some medical device clinical trials in the US will go into effect March 7, 2012 .

Guidance published by the FDA in late 2011 intends to update regulatory requirements for medical device manufacturers responding to

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has published its 2012 Strategic Prioritie s, which include improvements to pre- and post-market processes, internal and external communications, and efforts to support innovative product development.

A recent report by the US Government Accountability Office (GAO) finds that the Food and Drug Administration has not consistently taken steps to identify and track medical devices designated for pediatric use .

New draft guidance from the US Food and Drug Administration recommends improvements to medical device manufacturers’ clinical study designs in order to better assess safety and effectiveness of their products according to gender.

The US Food and Drug Administration has opened a 90-day comment period for

The US Food and Drug Administration is seeking further comment on its proposed approach for...

The Neurological Devices Panel of the US Food and Drug Administration’s Medical Devices Advisory Committee will hold a public meeting on February 10, 2012 to consider