Devices

Companies Making Cybersecurity Progress: Schwartz

CDRH associate director for science and strategic partnerships Suzanne Schwartz says medical device manufacturers have made “a fair amount of progress that has been very encouraging” in dealing with cybersecurity issues. In an audio interview with the Information Security Media Group, Schwartz says the agency has seen industry be “more forward-leaning in adopting what we call coordinated disclosure, establishing policies and procedures within their firms so they can be best prepared to receive information around medical device vulnerabilities…, work internally and with partners to assess that information, and then appropriately communicate around the vulnerability as well as the mitigation in order to reduce the potential for risk to patients.”

Asked to identify myths that continue to be repeated about medical device cybersecurity, Schwartz highlighted two:

the idea that manufacturers must come to FDA every time they have a software update or fix or patch that enhances cybersecurity; and
the notion that it is voluntary for manufacturers to follow FDA cybersecurity guidances.

She said the notion of voluntary compliance comes from the fact that FDA has issued its position in guidance documents that contain the words “non-binding recommendations.” But she added that there already are laws and regulations in place on cybersecurity and the guidances exist to tell industry how FDA recommends that they meet those requirements within the broader construct of the Quality System Regulation.

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