FDA Finalizes Regulation For Certain Software, Hardware Used With Medical Devices
Today, the FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards. "This rule is a common-sense regulatory approach ...

These FDA Approvals Aren't Guaranteed Forever
Follow the FDA's rules ... or else.

FDA Seeks To Invest In Foodborne Illness Prevention, Medical Product Safety And Countermeasures
The U.S. Food and Drug Administration is requesting a budget of $4.3 billion to protect and promote the public health as part of the President's fiscal year (FY) 2012 budget - a 33 percent increase over the FDA enacted budget for FY 2010. The FY 2012 request covers the period of Oct. 1, 2011, through Sept. 30, 2012. "FDA protects and promotes the health of all Americans through every stage of ...