Regulatory and Compliance
Jul 28, 2015
Stewart Eisenhart The current state of medical device regulatory environments worldwide is, as ever, a mixed bag in terms of ease of market entry,...
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 14, 2015
Marie Thibault Over the past several months, "right to try" laws have been passed in many states, and now similar legislation has made its way to...
Jul 13, 2015
Marie Thibault Public Citizen, a public advocacy group, wants to see a Sanofi surgical device taken off the market almost 20 years after it received FDA...
Jul 10, 2015
France—Pixium Vision   The Vision Restoration Systems (VRS) being developed by Pixium Vision in Paris are aimed at restoring sight to blind...
Jul 09, 2015
Marie Thibault It's time for another round of the reauthorization process needed for the next version of the Medical Device User Fee Act (MDUFA). To kick off...
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....