FDA expands Early Alert program to all medical devices

The FDA has expanded its Early Alert program to give the healthcare industry earlier visibility into potential high-risk medical device issues.

The agency’s Center for Devices and Radiological Health piloted the program in November 2024. The system was designed to reduce the time between when the agency first learns of a product removal or correction and when patients and providers are notified.

The program’s expansion, effective Sept. 29, means the FDA will now issue early alerts for all medical devices.

Unlike formal recall notices, early alerts signal when devicemakers remove products, update instructions or make corrections due to safety risks — even before the FDA confirms the issue meets the definition of a recall.