FDA accelerates medical device safety alerts to reach public within days

Editor's Note

The Food and Drug Administration (FDA) has expanded its early alert recall program to include all medical devices, speeding up how quickly the public learns about high-risk safety issues, Modern Healthcare October 9 reports. The initiative allows the FDA to post early alerts within days of manufacturers notifying customers, rather than waiting months for formal recall classifications.

Initially launched as a pilot last November, the program focused on five device categories—cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology. The FDA issued 17 alerts during the pilot phase, which were posted in its Medical Device Recalls and Early Alerts database. Following the program’s success, the agency expanded coverage on September 29 to include every type of medical device.

Under the traditional process, device manufacturers voluntarily report recalls or corrections to the FDA within 10 working days. The agency then evaluates the health risk, assigns a recall classification, and publishes an official notice. This review often delays public notification. The new system bypasses that lag, giving clinicians and consumers earlier access to safety information while formal assessments continue.

As detailed in the article, most early alerts during the pilot were issued 7 to 11 days after companies sent customer letters. By contrast, alerts for devices outside the pilot window took months—such as a Philips Respironics ventilator recall that was not publicized until 3 months after the company notified users.

The program stems from recommendations made by the FDA’s Patient Engagement Advisory Committee in 2021, which urged faster, clearer recall communications. The agency said the goal is to make potentially life-saving information accessible as soon as credible risks are identified. ECRI, the nonprofit patient safety organization, praised the move as a strong step toward transparency but called for clearer and more patient-friendly communication, particularly for devices used at home.