Devices

FDA Rejects Hearing Aid Standardization

FDA has denied a 5/3/21 petition submitted by Janice Lintz, a self-described hearing loss consultant and advocate, who asked that the agency “standardize the naming of hearing aid features and develop a rating system using international ANSI standards for various hearing aid features.” The denial letter says Lintz argued that manufacturers of new over-the-counter hearing instruments do not use common names for hearing aid features and comparing features is virtually impossible without consistent representations.

The agency says that while it agrees that interested people should have sufficient information to compare products as easily as possible, it did not standardize the names of device features or develop a rating system “because it was neither practical nor necessary to provide reasonable assurance of safety and effectiveness” for the new devices that were recently approved.

FDA also says it declined to adopt standardized names for hearing aid features because it is likely that hearing aid technology will continue to evolve and that device features will similarly evolve, including the specific capabilities. “This makes precisely identifying, describing, and naming those features and ways to compare them in regulation, even for the present, not practical or necessary for a reasonable assurance of safety and effectiveness,” it concludes…. “Once the final rule is in effect, we anticipate that purchasers will have access to a wealth of opinions from other purchasers, product testers or reviewers, and consumer information organizations. This will allow purchasers to find ratings that reflect their interests more than any possible criteria standardized by regulation.”

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