45 Device Alerts Issued in 2022: FDA

FDA has issued its first Postmarket Device Safety-Related Communications report to Congress as mandated by the 2023 Consolidated Appropriations Act. The law requires the agency to publish annually a report on the number of postmarket device signals communications issued, the sources of data for such signals, and how such signals were revised or resolved.

According to the report, from 1/1/2022 through 12/31/2022, CDRH issued 45 safety-related communications, including 30 Medical Device Safety Communications (see https://www.fda.gov/medical-devices/medical-device-safety/safety-communications) and 15 Letters to Health Care Providers (see https://www.fda.gov/medical-devices/medical-device-safety/letters-health-care-providers). Of the 45 device communications,

• Twenty-three provided new information about device safety
• Eight provided new information about device safety recalls that had resolved the problem (e.g., the device was removed from the market)
• Fourteen provided updated information about device safety previously reported