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 ...
On January 14, 2014, the U.S. Food and Drug Administration (FDA or “the Agency”) released a draft guidance document titled Custom Device Exemption. The draft guidance describes how the Agency ...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 ...
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 ...
Explore android vs ios customization in this smartphone comparison, breaking down key mobile OS differences to show what ...
Zach began writing for CNET in November, 2021 after writing for a broadcast news station in his hometown, Cincinnati, for five years. You can usually find him reading and drinking coffee or watching a ...
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