Report to Congress Shows How FDA Decides to Warn the Public About Devices

The Food and Drug Administration's device center posted a report to Congress on postmarket device safety-related communications on March 16, according to its news and updates page. The report says that from Jan. 1, 2023, through Dec. 31, 2024, FDA issued 51 device safety-related communications: 27 Medical Device Safety Communications and 23 Letters to Health Care Providers from the Center for Devices and Radiological Health, and one Safety and Availability Communication from the Center for Biologics Evaluation and Research.

Of the 51, the report says, 32 gave new information about device safety, six gave new information about recalls that had resolved the problem, such as removal of the device from the market, and 13 updated earlier communications. The previous edition of the report counted 45 safety-related communications from the device center in 2022, including 30 safety communications.

Congress required the reports in section 3307(b) of the Consolidated Appropriations Act, 2023, which directs FDA to report every two years on the number of postmarket device signal communications it issues, the sources of data for those signals and how they were revised or resolved.

Where the signals come from

New safety information may surface only after a device is used more widely, in routine practice, at home, in broader patient populations and by more clinicians, the report says. FDA monitors medical device reports, which are reports of certain adverse events and device malfunctions; reports from its MedSun adverse event reporting program; data from mandated postmarket studies; clinical trials and published research; and epidemiological work using claims data, registries and other databases.

For the 2023 and 2024 communications, the report lists the supporting information as complaints and allegations, device authorizations, shortages and supply chain concerns, inspections, laboratory evaluations, mandated postmarket study results, manufacturer reports of corrections and removals, medical device reports, real-world data, the scientific literature and labeling updates.

What the notices are for

FDA's safety communications page says the agency posts these notices "to describe the FDA's analysis of a current issue and provide specific regulatory approaches and clinical recommendations for patient management." Letters to Health Care Providers are a separate series. The report says the purpose of both is to give health care providers, patients and consumers the most current information on the performance, benefits and risks of marketed devices.

The most recent device safety communication before the report was posted was a March 4 update encouraging the public to follow established choking rescue protocols, and the one before that was dated Oct. 15, 2025, according to the page's list.

Other tools besides a warning

A public notice is only one response. The report lists other avenues the device center can take to resolve postmarket problems: requesting or requiring that a manufacturer remove a device from the market, conducting inspections, sending advisory action letters, issuing guidance, developing standards, requiring postmarket surveillance studies and "Upclassification of a device," such as reassignment to Class III. In some cases, the report says, the center decides that no action is required.