Devices

Health Affairs Suggests Hearing Aid-type Regs for Mobile Apps

A Health Affairs blog article suggests that FDA take a similar regulatory approach to the one it uses to oversee hearing aids for the emerging market of mobile health apps and wearables. For hearing aids, a product may be unregulated (e.g., personal sound amplification products) or regulated as a prescription-only device. Under FDA guidance, most mobile apps and some general wellness products would be considered devices, the article notes. However, the agency has been generally electing to exercise considerable regulatory discretion.

The article points out that many apps being offered in app stores are close to or over the regulatory line. “Frequently, they wear this almost as a badge of pride, noting how their apps are ‘not intended to’ diagnose or treat and are provided only for ‘informational and educational purposes,’” it says. “The FDA lacks the bandwidth to chase down all these minnows. Yet, existing device regulation scares off responsible innovators whose products iterate rapidly and who want to avoid a regulated distribution stack.”

Opening up a third category of regulated but OTC apps and wearables, similar to how personal sound amplification products are regulated, “would allow FDA to lightly regulate the space (e.g., with warnings about the limits of non-professional diagnosis, and record-keeping requirements) and experiment with new categories for emerging products for which the traditional risk-based framework may not be a good fit,” Health Affairs says. Further, if the agency also provided “bright line exemption for a larger number of non-invasive but diagnostic apps and wearables” it might encourage the consumer electronic industry to design better devices than the market is currently seeing.

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