In April 13 testimony before the US Senate’s Special Committee on Aging, Government Accountability Office...

The US Food and Drug Administration has allowed a six-month extension to health care facilities...

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has issued

The US Food and Drug Administration’s Office of Combination Products (OCP) has updated its guidance on Request for Designation (RFD) documents submitted by manufacturers or their sponsors in order to determine how to classify their devices. The revised guidance spells out more clearly what information the OCP requires within an RFD in order to more promptly determine whether a product should be regulated as a drug, device, biological product or combination product.

The Food and Drug Administration (FDA) has issued draft guidance on labeling of reusable

The US Food and Drug Administration has published final guidance targeting over-the-counter drug products packaged with syringes, droppers and other dispensing devices.

The US Food and Drug Administration has ordered all manufacturers of “metal-on-metal” artificial hip devices to conduct post-market studies to see whether the implants are malfunctioning or causing health problems in patients.

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has issued letters to

The US FDA’s Center for Devices and Radiological Health has released data on warning letter cites regarding manufacturers’ quality system deficiencies in 2010.

A new survey conducted by Northwestern University and funded by the Institute for Health Technology...