Regulatory/Legal
May 23, 2013
Catch up on some of the most popular stories and content on MDDIOnline   Medtronic CEO Omar Ishrak Gets It. Device Industry Needs to Clone Him Medtronic'...
May 17, 2013
When the Health Insurance Portability and Accountability Act, better known as HIPAA, was passed in 1996, AOL was just beginning to crawl and the iPhone was...
May 17, 2013
A doctor fights for a lower-tech, higher-empathy approach to end-of-life care. A career con man exposes how Google AdWords helped him run an illegal online...
May 10, 2013
Hospira Inc., GemStar Infusion System: Recall Posted 4/29/13, Updated 5/1/13 Damage from battery leakage may cause the device to shut off without warning. The...
May 03, 2013
China's FDA wants to boost the country's innovative device industry. A response to new European legislation on medical devices. University students' medical...
Apr 29, 2013
Like the tributes thrust into the Hunger Games arena, medical device manufacturers want a fair shot at surviving the ever-changing FDA 510(k) pathway. By...
Apr 26, 2013
Some big players in the medical device industry have taken a beating according to their earnings reports. FDA has authorized a smartphone app to help doctors...
Apr 11, 2013
 FDA's Office of Combination Products (OCP) has one goal in its dealings with device makers – to be 'APT” - appropriate, predictable, and...
Apr 02, 2013
Cody Wilson, a 25 year old law student at the University of Texas, has been making big headlines since a documentary about him produced by VICE magazine went...
Mar 27, 2013
 I’ve been hearing one question over and over in conversations over the past few weeks: “What is the Office of Combination Products (OCP)...