Devices

Stronger FDA Cybersecurity Enforcement Needed: Analysis

An analysis by the Institute for Critical Infrastructure Technology (ICIT) says that the FDA cybersecurity guidelines for medical device manufacturers are following a “subtle suggestion” approach when regulatory enforcement is needed. In a blog white paper, ICIT says that the argument against enforcing cybersecurity standards typically “centers on the idea that a regulatory presence stifles innovation.”

The paper reviews the FDA 1/15 guidance that advises medical device manufacturers to address cybersecurity “throughout a product’s lifecycle, including during the design, development, production, distribution, deployment, and maintenance of the device.” It says that the guidance offers a voluntary framework that organizations can build upon to ensure that their cybersecurity policies, procedures, and strategies address cybersecurity risks in medical devices before the organization, patients, or the public at large realize financial or reputational harm from the exploitation of an unaddressed vulnerability by an unknown threat actor.

“The medical device community is compliance-oriented,” the paper concludes. “Currently, healthcare device manufacturers and healthcare providers have the ability to ignore FDA’s recommendations. However, it is in the best interest of each organization and the community at large if the target audience pays attention to FDA’s underlying message to adopt a comprehensive risk-based cybersecurity program…. It may be beneficial to healthcare providers, healthcare payers, and legislators to petition FDA to make the guidelines regulatory. Otherwise, medical device manufacturers could ignore the guidelines altogether…. The cyber threat is real and bad actors are continuously evolving in both stealth and sophistication. Regardless of how medical device manufacturers and healthcare providers receive the guidelines, FDA has clearly indicated that medical device cybersecurity is a priority. The healthcare community should note the gesture and take the initiative to assess their own networks and improve their cybersecurity.”

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