DEVICE INDUSTRY LAYS OUT “INNOVATION AGENDA” (Orthopedics This Week)
AdvaMed, the medical device industry’s largest trade group, has unveiled an “Innovation Agenda” which it says will not cost a lot of tax dollars because the recommendations are mostly process reforms.
The set of policy proposals were released on February 10, 2015 and outline a series of regulatory, reimbursement, tax, international trade and R&D reforms which will help “speed patient access to the next generation of life-changing innovations,” according to the group.
The initiative includes specific recommendations under five policy pillars:
Improve FDA’s Regulatory Processes
Meet and exceed the groundbreaking 2012 user fee agreement goals for such key objectives as reductions in total review times and more frequent and substantive interactions between FDA and product sponsors.
Revitalize the “least burdensome standard” for regulatory review through enhanced reviewer training and encouraging the use of valid scientific evidence from such sources as registries, experience in foreign markets, and peer-reviewed journal articles, where appropriate, to support safety or effectiveness determinations.
Encourage FDA ...
