A new report issued by the US Food and Drug Administration argues that the European Union's regulatory system fails to ensure safety of high-risk medical devices it approves .

The US Food and Drug Administration is planning new premarket notification requirements for manufacturers of X-ray

The US Food and Drug Administration has published final guidance on its process for accepting and responding to 513(g) Requests for Information from medical device manufacturers and sponsors.

A new report from the US Government Accountability Office (GAO) provides yet more data showing...

Following last week's announcement that it would implement a pilot program in June waiving FDA GMP quality system inspections for manufacturers choosing to submit recent ISO 13485:2003 audit reports, the US Food and Drug Administration has published additional explanations of how its new program will work.

As part of a professed effort to align its regulatory practices more closely with those of Global Harmonization Task Force (GHTF) members, the US Food and Drug Administration is set to implement a

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