FDA Used Current Standards, Despite Bias Concerns, To Clear First OTC Pulse Oximeter

By Jessica Karins / March 20, 2024 at 3:49 PM
FDA is working to revise its standards for approving pulse oximeters to reflect evidence that the devices are less effective in patients with darker skin, yet it relied on current standards when it recently cleared for the first time an over-the-counter (OTC) pulse oximeter, as it is required to do when a device is substantially similar to one already cleared. Although the device maker adjusted its testing process to account for skin tone variation, the new OTC device will be...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.