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US industry takes issue with FDA's post-market failings claim

This article was originally published in Clinica

Executive Summary

AdvaMed is disputing a recent FDA study that found a high percentage of non-compliance with post-market studies, which are required as a condition for receiving product approval. "We feel that the characterisation of the medical device industry as being substantially out of compliance is both inaccurate and unfair based on the full facts," said Jeffrey Secunda, the association's associate vice-president for technology and regulatory affairs in a May 2 letter to the agency.

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