FDA issues draft guidance on distinguishing medical device recalls from product enhancements

FDA

The FDA issued draft guidance for medical device companies on distinguishing between a recall and a product enhancement that doesn’t need 1, saying it recognizes that "continuous improvement activities" "often have a favorable impact on medical device safety and are part of ongoing efforts to design and manufacture devices that meet the needs of the user and patient."

The aim is to help companies figure out when a recall is warranted, according to the federal watchdog agency.

The FDA’s Center for Devices & Radiological Health issued the draft guidance to "clarify when a change to a device constitutes a medical device recall, to distinguish those instances from product enhancements that do not meet the definition of a medical device recall, and to identify the associated regulatory reporting requirements for each."

"The recall process establishes a mechanism for firms that produce and market medical devices to take timely action to correct violative devices or remove them from the marketplace when correction or removal is necessary to protect the public health.  When a firm’s recall process is operating effectively, the firm identifies a device defect or failure, determines a recall is appropriate, and triggers the initiation of the recall process. However, firms may have trouble identifying whether a change to a device meets the definition of a recall, the appropriate scope of a recall, and when FDA should be notified of a recall.  All of these issues can result in inconsistent interpretation of regulations by firms, uncertainty in firms’ regulatory responsibility, and delays between the time a device defect or failure is identified and the time the public is notified," according to the agency. "When new iterations of a device involve changes to device design, it does not necessarily mean that the existing device has been recalled."

 

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