Devices

Pass Hearing Aid Rule Quickly: Grassley, Warren

Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) are urging FDA to quickly finalize its proposed rule on over-the-counter (OTC) hearing aids. In a statement (contains a link to the letter), the senators say the proposed rule is a result of their Over-the-Counter Hearing Aid Act that they moved through Congress in 2017.

“We write to urge FDA to finalize the rule without delay,” the senators said. “To ensure the final regulation is consistent with congressional intent, it must not contain any unnecessary restrictions that hinder access to over-the-counter devices or their utility for Americans with mild or moderate hearing loss. For these reasons, we strongly support maintaining the maximum sound pressure level identified in the proposed rule and oppose the introduction of any limits on gain. In addition, we believe that federal preemption of state laws governing the servicing, marketing, sale, dispensing, use, customer support, or distribution of OTC products is necessary to ensure consumers can access these devices without interference, as the Over-the-Counter Hearing Aid Act established. Maintaining these provisions will ensure that the final regulation successfully increases competition, spurs innovation, and brings down prices for consumers, while meeting the high standards of safety, manufacturing protections, and consumer labeling required of 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