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Senate Bill Would Encourage Adverse-Event Reporting Experimentation

This article was originally published in The Gray Sheet

Executive Summary

The new Improving Medical Device Innovation Act contains device provisions paralleling the House 21st Century Cures Act to make it easier for FDA to recognize consensus device standards, reform the advisory panel process and encourage more 510(k) exemptions. It also includes a new proposal that would trigger pilot projects for alternative approaches to adverse-event reporting.

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