Devices

Congress Should Ensure FDA Test Review Authority: Pew

The Pew Trusts says the Covid-19 pandemic has demonstrated the value in FDA reviewing laboratory-developed tests (LDTs) and says Congress should adopt reform legislation that would maintain the agency’s central role in overseeing diagnostic tests. An online paper says the agency’s regulatory authority over tests remains unclear, especially in light of an HHS 2020 decision to limit FDA’s oversight over LDTs.

“Congress should pass reforms, such as those proposed by the VALID Act (Verifying Accurate Leading-Edge IVCT Development Act) that would improve regulation of all in vitro clinical tests,” Pew says. The group says reforms would create a unified and risk-based oversight system while also protecting the emergency use authorization powers FDA used to increase Covid-19 testing capacity.

“Any legislative solution … should maintain FDA’s central role in overseeing diagnostic tests, and should ensure that they are held to the appropriate risk-based standards for quality, accuracy, and reliability, regardless of where they are developed and used,” Pew 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