IVDs (in vitro diagnostics) "perfect place" to start US total product life cycle approach
This article was originally published in Clinica
Executive Summary
The FDA's recent shift to a total product life cycle approach for the regulation of in vitro diagnostics does not mean more rigorous regulation lies ahead for this sector, agency officials stressed this week. "There is no hidden agenda," insisted Steven Gutman, director of the device centre's new Office of In Vitro Diagnostic Device Evaluation and Safety.