Devices

Senators Want Action on Hearing Aid Regs

Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) have written to acting FDA commissioner Brett Giroir asking for the status of proposed rules on over-the-counter hearing aids. In a 12/5 letter, Grassley and Warren note that President Donald Trump signed the Over-the-Counter Hearing Aid Act into law in 2017 and in 10/2018, FDA said its rules would be a priority on the Fall 2018 unified agenda and would be delivered well in advance of the 8/2020 statutory deadline.

“It is now 12/2019 and we have yet to see these regulations come to fruition,” the letter says. “Given the ever-increasing need for these devices, we request answers to the following questions:

· what is the status of the OTC hearing aid rules and regulations; and

· when does FDA expect to finalize the OTC hearing aid rules.”

The legislation allows the agency to categorize certain hearing aids as over-the-counter and to issue regulations regarding those hearing aids to ensure this new category of OTC hearing aids meets the same high standards for safety, consumer labeling, and manufacturing protections as all medical devices.

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