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US Regulatory Reads, August 2017: MDUFA IV; Risk-Benefit; Gastric-Balloon Warning

Executive Summary

The biggest US medtech policy news in August was enactment of the law reauthorizing medical-device user fees and making other US FDA reforms. But also attracting significant interest in Medtech Insight last month was our expert compliance tips, a deep-dive into FDA's new risk-benefit framework for making enforcement decisions and a safety alert from the agency tied to recently approved gastric balloons for obesity.

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