Regulatory/Legal
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)...
Mar 15, 2013
GOP lawmakers want to know if FDA plans to tax medical software apps. A company creates a prosthetic skull implant with 3-D printing. Sensors, the next step in...
Mar 04, 2013
The Scooter Store, the nation's largest power wheelchair company became a target of the FBI last week. Government auditors found that The Scooter Store...
Feb 25, 2013
Rochelle Rottenstein is a product liability attorney and the principal of Rottenstein Law Group (New York City).  A jury in Atlantic...