FDA has announced the expansion of its Early Alert Communications Program for medical devices, building on its 2024 pilot program aimed at minimizing the time between the Agency’s initial awareness of, and public communication regarding, potentially high-risk medical device removals or corrections. While the original pilot focused on a limited number of device areas (cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology), FDA will now issue Early Alerts for all medical devices.
In November 2024, FDA’s Center for Devices and Radiological Health (CDRH) launched a pilot to “improve the timeliness of communications about corrective actions being taken by companies that the FDA believes are likely to be high-risk recalls,” including removing products from the market, correcting products, or updating instructions for use due to potentially high safety risks.
FDA indicated that the pilot followed recommendations from patient advocates, and was intended to improve public safety communications where “FDA may not yet have determined that [manufacturer] actions meet the regulatory definition of a recall” but has been made aware of a potential high-risk issue.
Early Alerts are posted in FDA’s public Medical Device Recalls and Early Alerts database. They outline the affected product(s), the basis for the alert, “what to do” (the language for which appears to mimic company notifications sent to customers), and any reported deaths or injuries.
FDA has not issued further guidance on the criteria or process for Early Alert issuance. That said, it is clear that Early Alerts may be issued before a recall has been confirmed and before a manufacturer has completed its internal risk assessments.
Stakeholders may wish to review internal protocols to ensure readiness for earlier FDA engagement and heightened public visibility. Proactive planning now may help reduce business disruption and mitigate downstream risk.
If you have any questions concerning the material discussed in this client alert, please contact the following members of our Food, Drugs, and Devices practice.
Back
