The initiative provides faster notifications on potentially high-risk removals or corrections for all medical devices.
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has expanded its Early Alert communications program, which will now issue notifications for potentially high-risk removals or corrections for all medical devices. The expansion went into effect on Sept 29, 2025.
The program is designed to shorten the time between the agency’s initial awareness of a potentially high-risk medical device issue and its public communication. These alerts inform healthcare providers, patients, and consumers when companies remove products from the market, correct products, or update instructions due to potential high safety risks, even if the FDA has not yet determined that the action meets the regulatory definition of a recall.
The expansion follows a successful pilot program that CDRH announced on Nov 21, 2024. The Early Alert Pilot was developed as part of the center’s ongoing efforts to enhance its recall program, as outlined in the 2024 Safety Report, and incorporated recommendations from the Patient Engagement Advisory Committee.
According to the FDA, the program was designed using feedback from patients, healthcare providers, and consumers to make recall communications more timely, clear, and action-oriented. The agency notes that the publication of Early Alerts demonstrates its commitment to providing clear notifications about the safety and effectiveness of medical devices.
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