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The products were included in the new regulation to “introduce requirements around the manufacturing and surveillance of these previously unregulated products,” the agency said. Read More
According to the working plan, 33 NB designation applications were received as of mid-September and 22 joint assessments have been scheduled. Read More
The agency “should be focused on ensuring it has the tools and capacity to guarantee that software products that perform medical device functions are safe and effective and to hold companies that skirt the rules accountable,” the letter states. Read More
The FDA has released guidance for sponsors of devices with cybersecurity risks on what they should include in their premarket submissions, as well as considerations for device design and labeling. Read More
The potential for threats and vulnerabilities rises with increased medical device innovation and integration with hospital networks and technology. Read More