medical devices

Staff at the U.S. Food and Drug Administration (FDA) are reportedly struggling to meet application review deadlines for medical device and tobacco products due to recent staff reductions.

The U.S. Food and Drug Administration (FDA) is also stepping up its efforts to identify FDA-cleared medical devices that have been subsequently modified and that no longer fall within the scope of their original clearance.

The U.S. Food and Drug Administration (FDA) is advising medical device manufacturers to take steps to verify the accuracy and reliability of third-party testing data before submitting it to the FDA.

The IEEE has partnered with a major testing and standards development organization to create a new standard to address the securing of biomedical devices and health-related data.

The FDA releases landmark draft guidance for AI-enabled medical devices, offering manufacturers a roadmap for development, approval, and lifecycle management while addressing critical concerns of transparency and demographic bias.

The FDA has overhauled its medical device tracking system, streamlining how manufacturers identify everything from pacemakers to surgical robots in a global database refresh.

The FDA has classified a radiofrequency-based electric toothbrush as a medical device, establishing regulations to ensure the safety and effectiveness of this emerging dental technology.

The U.S. Food and Drug Administration has updated its list of authorized medical devices that incorporate augmented reality (AR) and virtual reality (VR) technologies.

As part of a broader effort to expand health outcomes across diverse populations in the U.S., the U.S. Food and Drug Administration (FDA) has published a Discussion Paper to facilitate a public discussion on how to advance health equity in connection with medical devices.

The IEEE Standards Association announced that several testing facilities operated by atsec Information Security have been officially recognized to conduct testing in accordance with the requirements of the IEEE’s Medical Device Cybersecurity Certification Program.