Medical Device Innovation Consortium Advances Regulatory Science Projects
This article was originally published in The Gray Sheet
At the Regulatory Affairs Professionals Society annual meeting last week, William Hawkins, chairman of the Medical Device Innovation Consortium, said the group is making progress in its first project on computer modeling and simulation, as well as future projects on clinical trial reform, and benefit-risk guidance and patient-centeredness.
You may also be interested in...
More collaboration between device companies and with FDA will be needed to employ sophisticated "virtual patient" computer models to reduce the number of patients needed in clinical trials, says Medtronic statistician Tarek Haddad.
The public-private partnership created to advance medical device regulatory science is starting 2014 with a renewed focus on its three projects and plans to possibly add a fourth to the mix.
A new FDA draft guidance establishes a voluntary process to validate publicly available device development tools so companies can routinely apply them to facilitate their path to market.