Devices

AdvaMed Supports Diagnostics Reforms in User Fee Reauthorization

While the FDA user fee reauthorization has hit some roadblocks on Capitol Hill (see earlier story), the Advanced Medical Technology Association (AdvaMed) is urging the House and Senate to come to terms on a reauthorization package that includes diagnostic reform provisions that were approved by the Senate Health, Education, Labor & Pensions Committee last month (see earlier story). The House version of the bill does not contain the diagnostic reform provisions, and differences between the two measures will be hashed out during conference committee negotiations.

In a 7/21 letter to both Senate and House lawmakers, AdvaMed said it supports the Verifying Accurate Leading-edge IVCT [in vitro clinical tests] Development (VALID) Act of 2022 that is included in the Senate version. VALID defines regulations for the tests and provides details for the premarket, abbreviated premarket, and supplemental application review and approval process, and it outlines the information required in such submissions. It also establishes conditions for certain tests to qualify for an exemption from the premarket review process.

“As you are aware, the [VALID Act] addresses a longstanding issue that has been recognized by administrations of both parties,” AdvaMed said in the letter. “The current federal approach to oversight has fueled regulatory uncertainty that jeopardizes investment in the next generation of diagnostics that will provide for improved patient outcomes. As Congress finalizes a legislative package reauthorizing FDA’s user fee programs, it can also seize this truly unique opportunity to advance a flexible, risk-based regulatory system for all in vitro clinical tests.”

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