Devices

AdvaMed Praises Bill Streamlining Some Device Approvals

AdvaMed says that the bipartisan Medical Product Review Harmonization Act of 2017 (H.R. 2474), sponsored by Reps. Mimi Walters (R-CA) and Ami Bera (D-CA), would establish an alternate review approach for a subset of moderate-risk Class 2 medical devices, making FDA review of these devices more efficient. “This new approach will allow the agency to grant 510(k) clearance based solely on compliance with objective, published criteria developed by FDA,” the trade association says in a statement praising the sponsors.

Currently, AdvaMed says, “FDA has developed ‘special controls’ and other guidance for a number of low- to moderate-risk devices that lay out specific testing and performance requirements in order for these devices to be deemed safe and effective and receive marketing clearance. Unfortunately, the current review process does not allow the agency to clear devices solely based on such requirements and necessitates product sponsors to prove their devices are also substantially equivalent to a currently marketed device. This means that FDA must review duplicative and redundant information, which is inefficient and delays patient access to needed advancements…. This alternate approach does nothing to change FDA’s robust requirements, but would allow a more efficient process for both the agency and product sponsors.”

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