Devices

AdvaMed Wants Early Engagement on Device Safety Notices

The Advanced Medical Technology (AdvaMed) Association has reiterated to FDA that early stakeholder engagement is critically important when the agency is considering medical device safety communications about currently marketed devices. In comments submitted to the agency regarding an 11/17/2020 public meeting on “Communications About the Safety of Medical Devices,” AdvaMed said early engagement with relevant manufacturers and healthcare providers “helps to ensure that the communication reflects accurate – and where appropriate, actionable – information from the outset.”

The device lobbying organization contends that “emerging signal communications issued prior to the agency having adequate, fully analyzed, validated and confirmed evidence, and without appropriate instructive recommendations, will create unnecessary confusion for healthcare providers and patients and could have unintended consequences including an adverse impact on public health and long-lasting reputational damage to valuable devices.”

AdvaMed also took issue with FDA’s position that it may not be efficient for the agency to engage with each of the impacted manufacturers in instances involving a large device class safety signal. “However, even in these instances, we strongly encourage FDA to offer the opportunity for dialog with, and collective input across, the relevant manufacturers, which can be facilitated by industry trade associations and other FDA partners,” the group says. “FDA’s leadership in engaging cross-industry discussion can help facilitate more rapid understanding of the issue and alignment of consistent messaging, and where applicable, identification of any differences within the class that should be noted for purposes of patient management.”

Additionally, AdvaMed says it supports standardizing the safety communication process, including clear identification and distinction of different types of communications. For example, if the communication involves a recall, then the communication should be grouped with other device recall communications on FDA’s Web site and separated from traditional safety communications or letters to healthcare providers to avoid confusion. “We also encourage the use of a template format for each type of communication to facilitate ease and consistency of use and comprehension,” the group says.

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