Devices

Senators Want OTC Hearing Aid Regs Issued

Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) are calling on FDA to quickly issue new regulations for over-the-counter hearing aids. In a 10/12 letter, they say their 2017 Over-the-Counter Hearing Aid Act “removes outdated regulations blocking consumer access to affordable hearing aids and allows certain types of hearing aids to be made available over-the-counter to Americans with mild or moderate hearing loss. By introducing more competition into the hearing aid market, the law will provide consumers with more options at a price they can afford.”

The letter says the legislation was passed in 2017 but FDA has not yet issued final regulations to implement it.

Their call for FDA to issue its regulations comes after President Joe Biden ssued an Executive Order on Promoting Competition in the American Economy in accordance with the hearing aid bill, the senators say.

The senators wrote that the FDA regulations “must succeed in increasing competition, spurring innovation, and bringing 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

Read more

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