North America
The US Food and Drug Administration (FDA), the authority responsible for medical devices regulation, issued guidance dedicated to 510(k) premarket notification submissions for Electrosurgical devices for general surgery. The scope of the document covers devices based...
North America
The medical device regulating authority in the United States, the FDA, issued special warning on cybersecurity threats related to cardiac implantable devices (ICDs). According to the document placed on the official website, the FDA aims to alert both companies and...
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