FDA Policy/General

MDIC Taps Booze Allen for Cybersecurity Help

The Medical Device Innovation Consortium (MDIC), of which FDA is a member, has announced a partnership with Booz Allen Hamilton to establish a benchmark of the medical device industry’s cybersecurity maturity and create resources to measure maturity over time. The benchmark will help the industry to improve product security by driving common improvements.

Under the partnership, Booze Allen will run its cybersecurity maturity model, collect and analyze data and publish a benchmark report. “This foundation and baseline will enable individual medical technology companies, Health Delivery Organizations (HDOs), and other stakeholders to more effectively establish long-term strategic plans to increase their cybersecurity maturity and efficiently track their progress,” MDIC says.

Furthermore, the initiative will also measure maturity of cybersecurity best practices through adoption of the 2018 Healthcare Sector Coordinating Council’s Joint Security Plan (JSP), according to MDIC. The JSP — an initiative co-led by FDA with the medical device industry and healthcare delivery organizations — addresses a total product lifecycle approach to cybersecurity. “By further advancing the adoption of the JSP, we can all work together to help transform the cybersecurity posture of medical devices from fragile to resilient,” says CDRH Office of Strategic Partnerships & Technology Innovation director Suzanne Schwartz.

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