New draft guidance from the US Food and Drug Administration recommends improvements to medical device manufacturers’ clinical study designs in order to better assess safety and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

The US Food and Drug Administration is requesting comment on its information collection practices regarding medical device recall policies.

US consumer advocacy group Consumers Union is arguing that Congress strengthen the Food and Drug Administration's ability to regulate medical devices in order to improve quality, safety and effectiveness.

Public comment is being requested through January 13, 2012 by the US Food and Drug Administration regarding data collection requirements for

Through new guidance published this month, the US Food and Drug Administration has clarified its review and approval process for its Investigational Device Exemption (IDE) regulations , and has also proposed steps to allow clinical investigations of high-risk medical devices in some instances where IDE approvals have not been finalized.

The US Food and Drug Administration is proposing a new policy for Investigational Device Exemption (IDE) applications for

The US Food and Drug Administration has extended its comment period to November 28, 2011 for guidance the agency issued