Devices

Stakeholders Want Cybersecurity Guidance Changes

Symantec says the current iteration of an FDA draft guidance on content of premarket submissions for managing cybersecurity in medical devices has “significant improvements over the previous version and helps align stakeholders to the shared mission of providing a more secure and safer healthcare system.” In a comment letter, the company suggests several improvements:

the document should include a deeper and more nuanced discussion and clarification of cybersecurity being an integral part of patient safety;
the proposed device risk tiers should be expanded to include additional aspects of harm/risk;
the document needs a more nuanced discussion rather than assuming certain types of medical devices with a particular feature set and capabilities; and

· some terminology used in the draft seems to be specific to the document and may not be aligned with precedents, common definitions, or typical industry understanding.

In its letter, Kaiser Permanente says standards development organizations are developing guidance for cybersecurity risk assessment methodologies for medical devices and it recommends that FDA continue working with those organizations to incorporate the other guidance documents into the FDA Consensus Standards Database and encourage adoption by medical device manufacturers.

Kaiser also asks for more clarification on the two-tier ranking of devices, intended manufacturer actions, and desired outcomes. “A risk-based approach with appropriate cybersecurity provisions, one that holistically assesses risks and mitigations throughout the entire product lifecycle, will move the industry forward toward trustworthy devices,” Kaiser’s letter concludes.

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