Girding For MDUFMA II: Premarket Review Unit Cost Study In Planning Phase
This article was originally published in The Gray Sheet
Executive Summary
FDA's unit cost analysis of premarket review resources may incite a long-term change to device user fee rates if certain application types prove more expensive to assess than previously believed
You may also be interested in...
PMA Review Costs Pooled In Unit-Cost Analysis; CDRH To Monitor Modules
FDA's cost study of its device review resources likely will consolidate labor data for traditional, modular, expedited and panel-track PMAs into one cohort, rather than track each application type separately
PMA Review Costs Pooled In Unit-Cost Analysis; CDRH To Monitor Modules
FDA's cost study of its device review resources likely will consolidate labor data for traditional, modular, expedited and panel-track PMAs into one cohort, rather than track each application type separately
CDRH Contracts Review Cost Auditor; Expedited, Modular PMAs On The Rise
FDA's device center is meeting review targets for expedited premarket applications, with just over a quarter of the fiscal 2004 cohort completed