Consumers Groups Praise FDA Draft ‘Emerging Signals’ Plan; Industry Continues Opposition
This article was originally published in The Gray Sheet
FDA’s proposed decision to start giving the public early warning of device risks in its “Emerging Signals” draft was praised by consumer and patient groups in March comments, but industry complained that the agency has no authority to issue early warnings. Companies say the communications will confuse patients and gives firms no chance to review the message FDA sends out about product risks.
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FDA Dec. 13 issued a final "emerging signals" guidance that includes some significant changes from the draft version released late last year. The update emphasizes that the agency will release to the public only confirmed information that it has seen on adverse events or other negative reports connected to a marketed medical device, which could change the product's risk profile.
In a draft guidance, FDA explains how it plans to communicate signs of postmarket device risks before it has performed a full analysis or developed specific recommendations.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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