Regulatory/Legal
Aug 03, 2015
FDA tarnishes its reputation as the regulatory "gold standard" with its stance on mercury-based dental amalgam. Jim Dickinson FDA has long glowed...
Jul 28, 2015
An FDA official gives a concrete example of how the agency decided that clinical trials without a control arm could be used to assess a certain type of device...
Jul 22, 2015
Senators have introduced a bill to streamline current FDA regulations for combination products. What does it entail? Marie Thibault Legislators this...
Jul 20, 2015
Despite strong interest, bids to overhaul the 510(k) regulatory process have hit a wall. The chances for reform seem to be waning—at least near term....
Jul 16, 2015
Read expert advice on how to implement FDA’s rule on current Good Manufacturing Practices for combination products. Mary C. Getz, PhD, Olivia Wong, D....
Jul 09, 2015
A patent law expert who worked closely with one of the latest darlings of the healthcare IPO world talks about the must-haves for a successful medtech IP...
Jul 06, 2015
Take these best practices into account when preparing to conduct a clinical trial outside the United States in order to support an FDA submission. Gordon D....
Jul 01, 2015
Two academics find that FDA is providing the right level of device regulatory oversight and posit that replacing some premarket clinical trials with postmarket...
Jun 30, 2015
Academic research points to FDA as the regulator with the appropriate amount of oversight for medical devices. Marie Thibault There's a surprising finding in...
Jun 29, 2015
Thinking about bringing your medical device to Canada? Get familiar with the basics of Health Canada regulations. Don Boyer In the almost 25 years I spent...