Devices

AdvaMed Wants 1 Medical Device Cybersecurity Guidance

AdvaMed says that FDA should better align its draft guidance on postmarket management of cybersecurity in medical devices with its premarket cybersecurity guidance. A 4/21 comment letter says that the trade group recognizes that combining the guidances “presents some administrative challenges [but] we believe the agency should combine both guidances into a single, holistic guidance on medical device cybersecurity.”

The trade association also says that because the agency is proceeding through guidance, it should clarify in the document that its recommendations are not prescriptive and should not form the basis of a citable event during an inspection. “This is particularly true given the number of technical guidances that FDA has released, which require the agency to take a flexible approach for cybersecurity management,” the letter says. “Should FDA intend for the recommendations described in the draft guidance to be prescriptive, the agency should proceed through notice and comment rulemaking.”

AdvaMed’s three general comments on the guidance are: (1) eliminate “essential clinical performance” from the document and instead focus on maintaining device functionality and safety, (2) provide more information about Information Sharing and Analysis Organizations, and (3) continue to rely on consensus standards such as the National Institute for Standards and Technology’s framework for improving clinical infrastructure.

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