U.S. Food and Drug Administration (FDA)

The FDA can't protect patients without knowing shortages are coming. While the EU implemented mandatory device shortage reporting in 2025, the U.S. still has no requirements—leaving pediatric patients especially vulnerable to supply chain disruptions.

The FDA's medical device recall oversight is failing—and staffing shortages are to blame. GAO's December report shows nearly three-quarters of recalls exceeded termination targets during 2020-2024, with congressional recommendations for strategic staffing increases now on the table.

The FDA has updated its lists of medical devices with digital health technologies, including AI-enabled devices, AR/VR medical devices, and sensor-based digital health technology. These FDA-authorized device lists help healthcare providers understand the current digital health landscape and support informed use of advanced medical technologies in patient care.

The American Hospital Association is urging the FDA to establish regulatory standards for AI-enabled medical devices. The AHA recommends an AI policy framework balancing healthcare innovation with patient privacy protection. AI medical devices have grown significantly in healthcare settings, particularly in diagnostic imaging and radiology applications.

The U.S. Food and Drug Administration (FDA) is seeking public comment on how best to evaluate the performance of artificial intelligence (AI) technologies integrated within medical devices.

FDA device clearance times remain lengthy—averaging 140–175 days, far beyond the 90-day goal. Staffing cuts and process shifts fuel delays, while underused third-party review programs offer a potential shortcut for manufacturers seeking faster approvals.

The U.S. Food and Drug Administration (FDA) has now rescinded 2024 rules that required laboratory-developed tests (LTDs) to comply with the agency’s pre-marketing authorization requirements applicable to medical devices.

The U.S. Food and Drug Administration (FDA) has recently updated its list of medical devices that have received market authorization under its Breakthrough Devices Program.

The U.S. Food and Drug Administration (FDA) has released data that it says affirms the safety of certain per- and polyfluoroalkyl substances (PFAS) used in medical devices.

The U.S. Food and Drug Administration (FDA) has reportedly sent warning letters to several medical device manufacturers for violations of its device marketing and good manufacturing practices requirements.