IVD Manufacturers, Labs Should Be Subject To Same Standards – AdvaMed
This article was originally published in The Gray Sheet
Executive Summary
FDA should allow in vitro diagnostic manufacturers to partake of some of the same regulatory flexibility that clinical labs currently enjoy, AdvaMed suggests to HHS in 1Aug. 23 comments on stimulating medical technology innovation
You may also be interested in...
FDA Genetic Test Oversight Is On The Rise, But How Far Can It Go?
It looks increasingly likely that FDA will play a larger role in genetic test oversight, though policymakers may soon have to decide just how much more the agency can and should do
FDA Genetic Test Oversight Is On The Rise, But How Far Can It Go?
It looks increasingly likely that FDA will play a larger role in genetic test oversight, though policymakers may soon have to decide just how much more the agency can and should do
Stakeholders To Address CMS Advisory Panel On Outpatient Payment Issues
Prosthetic urologists will be among device stakeholders seeking improved Medicare outpatient payment in 2005 when CMS' Ambulatory Payment Classification Advisory Panel convenes in Baltimore Sept. 1-3