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 US Food and Drug Administration (FDA) on Tuesday released a final rule that amends its regulations on the definition of a custom device so as to include new statutory requirements under the ...
Qosina’s line of Kynar barbed luer connectors come in various sizes and configurations and are kept in stock and ready for customer orders. Medical device makers pondering the materials and designs of ...
The US Food and Drug Administration (FDA) has issued a new final guidance document intended to clarify the process by which manufacturers of "custom" medical devices can comply with federal ...
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 ...
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 ...
A custom-made device is a medical device that is 'intended for the sole use of a particular patient' made 'in accordance with a written prescription'. In a dental setting, common examples of ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
The 1990s saw the introduction of three European directives that aimed to harmonise medical device legislation within the European Union (EU), which were given effect in the UK by The Medical Devices ...
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