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

In a draft guidance, FDA explains how it plans to communicate signs of postmarket device risks before it has performed a full analysis or developed specific recommendations.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.

FDA maps out a plan to alert patients, providers and the general public about emerging signals of problems with already cleared or approved devices before the agency has conducted a full analysis or developed specific recommendations in a draft guidance

released Dec. 30.

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