Regulatory/Legal
Mar 08, 2016
In addition to recommendations, guidance, and emergency use authorizations, FDA wants to do more to support development of Zika diagnostic tests. Marie...
Mar 07, 2016
A recent case in the U.S. Court of Appeals for the Federal Circuit upheld certain patent owner rights. A patent law expert explains why medical device...
Feb 29, 2016
Now that Robert Califf is in the top spot at FDA, what issues top his list of priorities? Marie Thibault Last week, the Senate confirmed Robert Califf, MD,...
Feb 22, 2016
As FDA considers leadless pacemakers, Boston Scientific is developing a new entry that could be used in coordination with its subcutaneous S-ICD. Here's...
Feb 18, 2016
Everyone, from new device entrepreneurs to engineers at mega medtech companies, runs into regulatory hurdles during the innovation process. Here's how each...
Feb 16, 2016
A few medical device makers are using direct-to-consumer advertising. What's holding the others back? Jim Dickinson The medical device industry’s...
Feb 11, 2016
In a new report, Public Citizen rails against a legislative proposal in the 21st Century Cures Act that would encourage FDA to approve high-risk medical...
Feb 01, 2016
Experts trace the harmonization of Japanese, FDA, and ISO guidelines on biocompatibility testing, as well as key disparities to know. Zhenghong Tao, Laurence...
Jan 25, 2016
What's in a name? A lot, when it comes to naming your new medical device. Here is an expert's advice on trademarks for medtech companies. Josh Gerben...
Jan 19, 2016
CDRH unveils its "patient power" initiative at the same time that a third patients' group rallies against the Center's medical device safety...