New Medical Device Law Mandates Nonvisual Access for Home-Use Tech: What It Means for CPAPs and Glucose Monitors

This new legislation, the Medical Device Nonvisual Accessibility Act of 2025, is pretty straightforward: it mandates that the user interfaces of certain new medical devices sold for home use must be accessible to people who are blind or have low vision. Think of devices like personal glucose monitors, CPAP machines, or other complex monitors that rely on screens and menus. The core requirement is that visually impaired users must be able to access information, interact, and use the device’s services “as easily, privately, and independently” as anyone else.

The Problem with Touchscreens and Beeps

Congress is finally catching up to the reality that a lot of essential medical care is moving out of the hospital and into our homes. If you’re managing a chronic condition, you might rely on a Class II or Class III device—the more complex, higher-risk stuff—that requires interaction via a screen or an app. If that interface only works visually, it completely excludes millions of people, forcing them to rely on a sighted person just to check their blood pressure or adjust their sleep settings. This bill aims to fix that by requiring manufacturers to bake in nonvisual access (like screen readers, tactile controls, or audio feedback) from the start. This rule only applies to new devices that get marketing authorization after the regulations take effect, ensuring existing tech isn't immediately yanked from the shelves.

Waivers and the ‘Undue Hardship’ Question

While this is a huge win for independence and safety, the bill does include an escape hatch for manufacturers. The Secretary can grant a waiver if a company provides "clear and convincing evidence" that meeting the standard would either fundamentally change the product (making it unusable for its main purpose) or cause an "undue hardship." That second part—undue hardship—is where things get a little fuzzy. It means “significant difficulty or expense,” judged against the manufacturer’s overall financial resources. This is necessary because some devices might genuinely be impossible to adapt without a complete redesign, but the vagueness of “undue hardship” could become a loophole. We’ll need to watch how the FDA defines that term, because a giant medical device company’s “hardship” looks very different from a startup’s.

The Regulatory Clock Is Ticking

For those who need this technology, the wheels of bureaucracy turn slowly. The bill sets a clear timeline: the Secretary must propose the new rules within one year and publish the final, official rule within two years of the law passing. The rules then take effect one year after publication. Once that final date hits, any new “covered device” that fails to meet the nonvisual accessibility standard—and hasn't received a waiver—will be considered “adulterated” under the Federal Food, Drug, and Cosmetic Act. That’s the regulatory equivalent of being declared illegal. Manufacturers are on notice: integrate accessibility now, or risk getting shut out of the market later. The FDA is also tasked with setting up training programs to help companies figure out how to meet these new design requirements.