FDA Expands Early Alert Program to All Medical Devices

By Emily Statham and Brett W. Johnson

On September 29, 2025, the U.S. Food and Drug Administration (FDA) announced the expansion of its Early Alert program to include all medical devices. This expansion builds on a pilot program that introduced Early Alerts for medical devices in only five therapeutic areas. Under the expanded Early Alert program, the FDA seeks to shorten the gap between its initial awareness of potentially high-risk medical device removals or corrections and public notification. Companies should take the opportunity to update internal policies and procedures and risk assessment programs to integrate the Early Alert program in safety and global supply chain initiatives.

Background

Unlike traditional medical device recalls, which follow a structured and detailed process under 21 C.F.R. Part 806, Early Alerts are preliminary public communications that quickly notify patients, healthcare providers, and other stakeholders about potentially high-risk safety issues involving medical devices. The FDA’s Center for Devices and Radiological Health (CDRH) launched Early Alerts via a pilot program on November 21, 2024. The express goal of that pilot program was to “improve the timeliness of communications about corrective actions being taken by companies that the FDA believes are likely to be high-risk recalls.” Though the pilot program did not change the FDA’s extant recall procedures or timelines, it introduced Early Alerts for medical devices in five high-risk therapeutic areas: cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology.

Expanding the Pilot Program

The pilot program demonstrated that Early Alerts provide timely, actionable information about device removals or corrections that may pose significant risks to patients. On several occasions, the FDA posted Early Alerts on its public Medical Device Recalls and Early Alerts database within just days or weeks of a company’s initial customer letter. This marks a drastic shortening of the FDA’s two-to-three-month timeline for publishing traditional notifications of high-risk medical device recalls. 

Feedback from patients, healthcare providers, and industry stakeholders presumably indicated that Early Alerts improved transparency and allowed for more timely risk mitigation. Based on the perceived success of the pilot program, the FDA announced on September 29, 2025, that it would expand the Early Alert program to cover all medical devices — not just those in the original five therapeutic areas. This expansion marks a significant step forward in the FDA’s efforts to enhance medical device safety and ensure that critical information reaches the public as quickly as possible.

Implications for Stakeholders

The FDA’s decision to expand the Early Alert program has several important implications for healthcare providers, health systems, and medical device manufacturers. First, hospitals, clinics, and supply chain teams should consider monitoring Early Alerts more broadly as a part of a larger risk assessment program. Second, stakeholders should consider updating internal protocols to streamline the process of segregating inventory and communicating with clinical staff as soon as a new Early Alert is posted.  

Similarly, biomedical engineering and risk management teams should consider adjusting workflows to ensure prompt response to a wider range of device safety issues. In addition, while efforts to notify patients and the public are important, companies should consider notifying existing supply chains of vendors and affiliated providers. This ensures maximum awareness of both the product subject to the Early Alert and related items and their manufacturers. In addition, such early notification may lead to stopping international shipments (to avoid seizure or unnecessary tariffs), terminating supplier contracts, or triggering other dispute resolutions related to implicated supply agreements.

Finally, medical device manufacturers can expect that high-risk issues may become public much earlier in the process — sometimes even before the FDA confirms a recall or a manufacturer completes an internal risk assessment. Voluntary pre-notification to the FDA may therefore become more consequential. By proactively planning for earlier public awareness of medical device corrections and removals, stakeholders can mitigate downstream risk.