Regulatory/Legal
Jul 11, 2016
RTI vs Becton Dickinson Retractable Technologies, Inc. (RTI) brought a case against medical device giant Becton Dickinson (now BD) in June 2007. The...
Jul 11, 2016
Arthrex vs Smith & Nephew It's a stretch to call Arthrex small, since the orthopedic company is one of Florida's largest private companies with...
Jul 11, 2016
Here are five instances of small companies that brought patent challenges against medtech giants—but did it pay off?   Patents and technical know-how...
Jul 07, 2016
Would-be manufacturers of antimicrobial-treated devices should familiarize themselves with seven important FDA requirements for 510(k) submissions for these...
Jun 30, 2016
The public floods FDA with hundreds of comments urging the agency not to change its regulations to allow hearing aids to be sold over the counter. Marie...
Jun 23, 2016
FDA and other global regulatory bodies have been busy in 2016. These are some of the biggest regulatory developments so far this year.  Marie Thibault In...
Jun 20, 2016
The ISO 13485:2016 update will have a significant impact. Here's what medical device manufacturers need to know. Bart Reitter In March, the International...
Jun 17, 2016
Physicians are identifying flaws in regulatory oversight of medical devices and publicizing their findings. Jim Dickinson The FDA regulatory scheme for...
Jun 06, 2016
FDA's draft guidance addresses considerations for additive manufacturing in medical devices, but stops short of answering some key questions. Yarmela Pavlovic...
May 16, 2016
What is behind the public's wariness of the 21st Century Cures Act? Jim Dickinson As many in industry look forward hopefully to the enactment of the...