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Pharma Compliance Info FDA details tracking of medical device 'emerging' safety signals Pharmacovigilance

FDA details tracking of medical device ’emerging’ safety signals

The FDA just released a guidance formalizing its practice of notifying the public of “emerging signals,” or situations in which the agency is monitoring risks that have not yet been fully validated, and for which the agency does not have specific recommendations.Pharma Compliance Info FDA details tracking of medical device 'emerging' safety signals Pharmacovigilance
The latest guidance appears to be inspired by that episode, and includes a list of considerations for determining when to notify the public of an “emerging signal,” as well as the template for communicating the issue. The issuance of a formal policy suggests the FDA anticipates increased communication of emerging signals as it beefs up its surveillance capabilities through tools like UDI and post-market monitoring.

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