The Food and Drug Administration has issued guidance on the distinctions between medical device recalls and medical device enhancements.

The differences between the two might seem obvious, but the regulatory definitions and status of these medical devices can be confusing. The FDA guidance is intended to clarify when a potential change to a device is a medical device recall, distinguish those instances from product enhancements, and explain reporting requirements.

“When a firm’s recall process is operating effectively, the firm identifies a device defect or failure, determines that a recall is appropriate, and triggers the initiation of the recall process,” states the guidance. “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.”

As the regulatory agency points out, defects or performance failures of marketed medical devices can pose serious risks to public health and confusion about what distinguishes medical device recalls from product enhancements can result in delays in notifying the public about unsafe devices. At the same time, the FDA makes the case that a device enhancement is not a medical device recall.

“When a new iteration of a device has improved design, for example, this does not necessarily mean that the prior version of the device should be recalled,” states the guidance. “Such changes may be appropriately characterized instead as product enhancements. In addition to determining whether a proposed change to a marketed device meets the definition of a device recall or a product enhancement, a firm must assess whether it is required to report the change to FDA.”

The eight-page document includes a question-and-answer format, providing responses to questions that FDA believes are helpful in properly distinguishing medical device recalls from medical device enhancements and the related reporting obligations.


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