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FDA Drafts Plan To Publicize 'Emerging Signals' Of Device Risks

This article was originally published in The Gray Sheet

Executive Summary

In a draft guidance, FDA explains how it plans to communicate signs of postmarket device risks before it has performed a full analysis or developed specific recommendations. Public health advocates say it is a positive move to get ahead of potential safety problems early. The agency is seeking comment from companies on whether it needs to consult with firms prior to releasing information on emerging signals about their devices.

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