FDA Changes Medical Device Recall Communication

FDA says it has changed the way in which CDRH communicates about medical device recalls. As of 1/3, it says, information will be posted in the searchable Medical Device Recalls Database much earlier than previously. Now, the information will be posted when a firm takes a correction or removal action and notifies FDA that the information can be posted, rather than at the time the agency classifies a recall.

“This change is being implemented to minimize confusion among patients and healthcare providers that can arise from a delay between a firm’s initiation of a correction or removal action and FDA’s subsequent announcement of a recall classification,” the agency notice says. “The new timelines for FDA to post information will help ensure that the FDA Web site contains information about medical device corrections and removals shortly after a firm notifies its customers.” The process and timelines for reporting a correction or recall have not changed, the agency says.