9 changes to FDA goalposts for medical devices

A potential silver lining for medical device developers and manufacturers exists in the FDAs response to 2016 “21st Century Cures Act”, with publication of a…

FDA Quality System Regulation and ISO 13485

A ray of sunshine has appeared for medical device developers seeking to market their devices in the US as well as other territories. Often, manufacturers…

A flurry of activity from FDA

It’s been a busy week for the US Food and Drug Administration’s CDRH.  In the space of a couple of days, the Center has published…

Human Factors high on FDA Priorities for 2016

So, the FDA’s Center for Devices and Radiological Health (CDRH) have included Human Factors in their 10 priorities for 2016 and Regulatory Science. There have…

CDRH New Year’s resolutions

The FDA has shared its New Year’s resolutions, including the guidance documents the Center for Devices and Radiological Health intends to publish in 2016. In…