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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industry to clarify benefit-risk considerations for medical devices have moved into the post-market space, with the FDA draft guidance and a draft report from a working group led by the Association for the Advancement of Medical Instrumentation (AAMI), both issued on June 151-3.