FDA Eliminates Delay in Posting Actions in its Medical Device Recall Database


Shortly after the turn of the year, the FDA began posting information in its Medical Device Recall Database when a vendor takes a correction or removal action and notifies the agency rather than at the time of an FDA recall classification—much earlier than in the past.

The process and timelines for reporting a correction or removal action by a vendor will remain exactly as it was in the past. However, when a vendor reports the action, the District Recall Coordinator will ask if the information is ready to be posted. If the vendor agrees, the FDA will post the information in the Medical Device Recall Database and the OpenFDA Device Recalls API.

According to a communication this week to the medical device industry, the action is being taken to minimize confusion among patients and health care providers that could result from the lag between the time that a firm initiates 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,” according to a communication from the agency.