US FDA, AAMI Consider Device Benefits And Risks In Post-market Phase
This article was originally published in SRA
Executive Summary
Efforts by the US Food and Drug Administration and industry to clarify benefit-risk considerations for medical devices have moved into the post-market space, with the FDA draft guidance and a draft report from a working group led by the Association for the Advancement of Medical Instrumentation (AAMI), both issued on June 151-3.