Devices

FDA, DARPA Push Trustworthy Hardware

FDA and Defense Advanced Research Projects Agency staffers said at a recent Silicon Flatiron event that hardware security and trust must involve the integration of hardware and software protection strategies, as well as resilient build practices. FDA cybersecurity policy advisor Jessica Wilkerson said the growing integration of hardware and software has led the agency to tighten security expectations for both, Government CIO reports in an online story.

“The system design, whether it’s a cybersecurity component, it’s a hardware component, whatever it is, it has to take into account the cybersecurity risks that could be faced and potentially mitigate for them,” Wilkerson said. “We need to be paying attention to the interplay between the hardware and some of the other components.”

She added that cybersecurity often focuses on the protection of the network and argued that with the advancing nature of hardware, engineers must build solutions that bake security controls into the devices themselves.

“Anywhere you can put on a security control, just put the security control on,” she said. “There are so many automated exploit kits out there…. It’s very difficult to protect against everything, but especially on the FDA side, the devices have to be protected…. Something is going to happen. There’s going to be a configuration error. There’s going to be an attack. Someone who’s going to deliberately try to screw with your systems — it’s not an if, it’s a when. Your system, to me, is not trustworthy unless you can weather whatever it is.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome