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Medical devices and cybersecurity: FDA calls for comprehensive risk management programs

Diane Romza-Kutz March 30, 2016
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Market growth, along with the growing sensitivity on cyber safety, has caused the FDA to turn its attention to cybersecurity and protecting public health from vulnerabilities presented by the increasing use of software in medical devices. READ MORE

FDA Update: New guidance released on mobile medical devices, medical devices data systems

Diane Romza-Kutz September 3, 2015
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In the newly updated Guidance, the FDA stresses, in particular, the purposes of the two platforms as well as the difference between the hardware on which they are run. In the case of an MMA, the software in question is run on a handheld device, such as a cell phone, tablet or similar device. READ MORE

FDA issues social media guidance

June 26, 2014
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Earlier this month, the FDA released proposed two-part Guidance on Internet and social media intended to assist prescription drugs and medical device manufacturers to accurately communicate online about their products. READ MORE