Medical Device Innovation Consortium Sets Priorities To Advance Reg Science
This article was originally published in The Gray Sheet
Executive Summary
The heads of the newly formed private-public partnership comprising industry, academia and FDA describe the group’s top three projects to advance medical device regulatory science.
You may also be interested in...
People Briefs: CEO At LifeScience Alley; Orthofix, Exact Sciences Appoint Board Chairs
LifeScience Alley CEO Dale Wahlstrom retires and Shaye Mandle named successor. Orthofix International and Exact Sciences name new board chairs. Wound Management appoints new CFO, director of R&D and chief medical officer. Other people news.
FDA Steps Up Focus On Computational Modeling For Devices With Draft Guidance
The draft guidance outlines information on computational and simulation modeling studies that should be included in FDA device submissions. FDA has been encouraging companies to focus on modeling studies with a goal that they could eventually replace costly bench and animal studies.
FDA Steps Up Focus On Computational Modeling For Devices With Draft Guidance
The draft guidance outlines information on computational and simulation modeling studies that should be included in FDA device submissions. FDA has been encouraging companies to focus on modeling studies with a goal that they could eventually replace costly bench and animal studies.