Jun 20, 2016
The ISO 13485:2016 update will have a significant impact. Here's what medical device manufacturers need to know.
In March, the International...
Jun 17, 2016
Physicians are identifying flaws in regulatory oversight of medical devices and publicizing their findings.
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FDA's draft guidance addresses considerations for additive manufacturing in medical devices, but stops short of answering some key questions.
May 16, 2016
What is behind the public's wariness of the 21st Century Cures Act?
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.
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.
Apr 15, 2016
Why is FDA proposing a ban for powdered gloves but shows no signs of pursuing a ban for other devices that have raised patient safety concerns?
Nancy Stade, JD...
Mar 21, 2016
In this Q&A, an expert gives medtech innovators advice on building a regulatory and commercial strategy early in the development cycle, including how to...