miércoles, 4 de enero de 2017

CDRH Industry: CDRH to Post Early Notification of Recalls

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Dear Medical Device Industry,
We want you to be aware of an important change in the way that CDRH will communicate about medical device recalls. 
Beginning January 3, 2017 we will post information in the searchable Medical Device Recalls Database much earlier than we have done previously – at the time a firm takes a correction or removal action and notifies us that we can post it, rather than at the time of FDA’s recall classification.  We will also make this information available in the OpenFDA Device Recalls API.
The process and timelines for reporting a correction or removal will not change. Please continue to work with your District Recall Coordinators.  When you provide the required information, your district recall coordinator will ask whether the information is ready to be posted. If you agree, the FDA will post information regarding the correction or removal action in the searchable Medical Device Recalls Database and in the OpenFDA Device Recalls API.  We will update the Medical Device Recalls Database and the OpenFDA Device Recalls API after the recall is classified and again when it is terminated.
This change is being implemented to minimize confusion among patients and health care providers that can arise from a delay between a firm’s initiation of a correction or removal action and the FDA’s subsequent announcement of the recall classification.  The new timelines for FDA to post information will help ensure that the FDA website contains information about medical device corrections and removals shortly after a firm notifies its customers. 
For additional information, please see Medical Device Recalls.
FDA’s Center for Devices and Radiological Health

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