Devices

AdvaMed Points ONCD to Cyber Harmonization

Responding to an Office of the National Cyber Director request for information on opportunities for and obstacles to harmonization of cybersecurity regulations, AdvaMed points out that FDA “is the primary authority in regulating medical devices, including establishing that they are cyber secure. FDA administers comprehensive regulations and implementing guidance that prescribes the management requirements that medical technology manufacturers must comply with and for which they face severe penalties for failing to follow.”

The trade association’s comment letter also cites the many other harmonizing groups that AdvaMed works with, including the International Medical Device Regulators Forum and the Health and Healthcare Sector Cybersecurity Coordinating Council Joint Cybersecurity Working Group.

“There are already numerous domestic and international harmonization efforts for medical device cybersecurity regulations and these efforts include participation from relevant stakeholders, including medical device regulators and manufacturers, healthcare providers and their organizations, and patients,” the 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