Regulatory/Legal
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...
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...
Mar 21, 2016
Japan is a major market for medtech companies. Here are the details on how the country's medical reimbursement system works. Keisuke Suzuki Health...
Mar 17, 2016
A recently-acquitted medtech executive has angrily aired objections to how federal prosecutors handled his case. Could a recent memorandum from the deputy...
Mar 16, 2016
Regulation can be a challenge for startups. Hear what one expert said was the biggest mistake she saw entrepreneurs make in approaching FDA during her years at...