Regulatory/Legal
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FDA's draft guidance addresses considerations for additive manufacturing in medical devices, but stops short of answering some key questions.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...
May 09, 2016
A top CDRH official answers our questions on pressing issues in digital health regulation at FDA. Marie Thibault Interoperability, mobile medical apps, and...
Apr 28, 2016
Patent trolls aren't only a U.S. phenomenon. Two legal experts discuss why nonpracticing entities have impacted medical device companies doing business in...
Apr 27, 2016
Why doesn't FDA mention its own human factors guidance in another recent technology-specific guidance document? William A. Hyman On April 20, 2016, FDA issued...
Apr 18, 2016
Patients injured by medical devices have stepped up their attack on CDRH director Jeffrey Shuren, appealing to Congress to fire him. Jim Dickinson The...