In 1976, Congress enacted the Medical Device Amendments (MDA). This law, now part of the Federal Food, Drug, and Cosmetic Act (FD&C Act), generally requires FDA clearance or approval before a new ...

The pacemaker is a medical device that was initially introduced in 1958. At that time, the device used external components and was far from inconspicuous or convenient. Image Credit: Amphenol Sensors ...

Get a handle on your privacy and set up your preferences on every device Most modern tech lets you open a settings menu to adjust how the device works. Whether it’s a smartphone, computer, tablet, ...

On January 14, 2014, the U.S. Food and Drug Administration (FDA or “the Agency”) released a draft guidance document titled Custom Device Exemption. The draft guidance describes how the Agency ...

The European Commission’s Medical Device Coordination Group (MDCG) on Monday issued a new questions and answers document addressing custom-made medical devices under the Medical Device Regulation (MDR ...

Explore android vs ios customization in this smartphone comparison, breaking down key mobile OS differences to show what ...

The downsizing of medical devices in critical care is improving patient treatment. More elegant and advanced, smaller medical devices are enabling medical professionals to deliver enhanced care in ...