CDRH Speeds Release of Device Recall Information

Regulatory NewsRegulatory News | 03 January 2017 |  By 

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday began posting medical device recall information in a searchable database much earlier than the agency ever has before.

The information is now posted in CDRH’s Medical Device Recalls Database at the time a firm takes a correction (which addresses a problem with a device in the place where it is used or sold) or removal action (ie., Removing the device from the market) and notifies FDA that it can post the information, rather than at the time of FDA’s recall classification. 

The agency said the change in posting the information earlier is intended to minimize confusion among patients and health providers that arose from previous delays between a company’s initiation of a correction or removal action and the FDA’s subsequent announcement of the recall classification. 

In 2016, FDA issued 39 device recalls, which was slightly more than the 32 recalls from 2015 but significantly less than the 60 recalls from 2014.

“The process and timelines for reporting a correction or removal will not change. Please continue to work with your District Recall Coordinators,” FDA said in a statement to industry Tuesday. “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.”

In addition, FDA may post company press releases or other public notices about recalls, market withdrawals and safety alerts that may potentially present significant risks to consumers or users of the product.

Medical Device Recalls


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