Stakeholders Give FDA An Earful; Poor Communication, Recall Inefficiency, Patients At Risk

During a recent listening session on modernizing its recall process, the US FDA heard from industry, consumers, and patients — all of whom expressed a common theme: the agency needs to up its game in how it handles recalls.

Time To Modernize
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Amy Barnett posed a classic Catch-22 scenario: how can she report a problem with a device that might lead to a recall if she doesn’t even know that device is inside her body?

What this illustrates, Barnett said, is a fundamental problem plaguing the Food and Drug Administration’s recall process: poor communication.

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