Devices

Device Shortages Need More Transparency: FDA

CDRH researchers say the medical device shortage early reporting requirements included in the CARES Act facilitated early identification and mitigation of device shortages during the Covid-19 pandemic. Writing in Health Affairs, they say (purchase required) that outside of public health emergencies, the agency does not have the regulatory authority to require such information from manufacturers.

Moreover, they add, the notifications required under the CARES Act are less comprehensive than those for pharmaceuticals, which require a risk management plan and the number of drugs involved in a shortage. The researchers say that having the kind of information required for drugs enhances FDA’s ability to prevent or mitigate shortages.

“Understanding the characteristics of medical device shortages is a first step toward mitigating their potential impact,” the study says.

The authors say that shortages of critical medical devices during the pandemic exposed vulnerabilities in device markets. From 2010 to 2019, they write, there were about five shortages annually, but that number increased fourfold in the first half of 2020. “Although most 2020 shortages were triggered by the pandemic,” they say, “pre-2020 shortages stemmed from regulatory and enforcement actions related to product quality and manufacturing.”

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