How Early is Too Early? CDRH Expands Early Alert Communications for Potentially High-Risk Device Recalls

How Early is Too Early? CDRH Expands Early Alert Communications for Potentially High-Risk Device Recalls

By Steven J. Gonzalez & Anne K. Walsh —On September 29, 2025, FDA announced that it would be expanding its use of “Early Alert” communications for potentially high-risk device recalls, having determined that the pilot of this program was a success. The pilot program, initiated November 21, 2024, sought to minimize the time between FDA’s initial awareness of and public communication of potentially high-risk medical device recalls. Under the pilot…