French set up group to oversee device clinical trials
This article was originally published in Clinica
Executive Summary
The French healthcare products safety agency, AFSSAPS, has set up an expert group to advise it on issues surrounding the use of medical devices in clinical trials. Its responsibilities will include to advise it on any matters it believes need addressing, such as if it considers an application for trials requires additional information, where changes are needed to trials proposals, or if trials should be suspended or banned.