Devices

Grassley, Warren Seek FDA Hearing Aid OTC Rule Action

Sens. Charles Grassley (R-IA) and Elizabeth Warren (D-MA) have asked FDA to issue its proposed rule on over-the-counter hearing aids as quickly as possible. In an 11/13 letter, the senators say that since President Donald Trump signed the Over-the-Counter Hearing Aid Act into law in 2017, FDA has promised it would issue its regulations implementing the law by the statutory date of 8/18/20.

“In October 2018, FDA announced that these rules would be a priority on their Fall 2018 unified agenda and that the agency would be able to deliver the proposed rule in advance of the deadline,” Grassley and Warren write. “And in February of this year, the agency informed us that it was ‘developing a proposed rule to issue by 8/18.’ However, FDA has yet to issue its OTC hearing aid proposed rule.”

The letter says it is not possible to overstate the impact of Covid-19 on FDA’s priorities and reaffirms the senators’ appreciation for the agency’s efforts to respond to the global health crisis. “However,” they conclude, “despite the pandemic, hearing loss continues to be a problem for millions of Americans, and we believe that FDA must make issuing the OTC hearing aid regulation a priority, consistent with the law. We respectfully request that the agency release the proposed rule without delay.”

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