FDA Releases New Guidance on Wellness and Software Products
Overview of the Changes
On Tuesday, the Food and Drug Administration (FDA) issued two final guidance documents aimed at easing regulations for specific wellness and software products. FDA Commissioner Marty Makary announced these changes at the Consumer Electronics Showcase (CES), emphasizing that they would “promote more innovation with AI in medical devices.”
Wellness Exemptions for Blood Pressure and Blood Glucose
The first guidance document clarifies the FDA’s definition of wellness devices, providing greater flexibility for wearables that monitor heart rate, blood pressure, and blood glucose, as long as their intended use is strictly for wellness purposes.
The FDA provided examples in the guidance, noting that a wrist-worn device tracking metrics like sleep, pulse rate, and blood pressure could qualify under a general wellness claim, assuming it has validated blood pressure values. This guidance seems to contradict a warning letter issued to the wearable company Whoop last year for launching a blood pressure feature without prior authorization, where the FDA had stated that blood pressure is intrinsically linked to medical diagnoses. A spokesperson for Whoop praised the new guidance, indicating it clarifies that the company can now provide blood pressure insights as part of wellness metrics designed for non-medical purposes. They noted that these changes should “help resolve long-standing uncertainty about the boundary between providing wellness insights and medical diagnosis and treatment.”
Another example discussed involves a wearable device designed to estimate blood glucose levels to monitor dietary impacts, which is explicitly contraindicated for individuals with diabetes and pre-diabetes. According to the guidance, this device could fall under a general wellness claim but would not be classified as low-risk if it utilized microneedle technology for estimations. The FDA also cautioned consumers in 2024 against using smartwatches or rings claiming to measure blood sugar without skin penetration.
Makary commented during his CES speech, “In the past, the FDA has permitted some measurements like pulse rate and O2 saturation in some wellness products, but not others. It didn’t always make a lot of sense from the outside.” Tom Hale, CEO of Oura, a company developing a wearable ring with a blood pressure feature, welcomed the new regulations in a LinkedIn post, stating, “As wearables continue to evolve, modern regulation that recognizes the difference between early awareness and medical diagnosis is critical.”
Changes to Clinical Decision Support Software Regulations
In a separate guidance, the FDA announced significant modifications to its regulatory approach concerning clinical decision support tools. A notable change includes the criteria for determining whether software is providing recommendations to healthcare providers. Now, software that delivers a sole medical recommendation can be exempt from regulation, contrasting with previous guidelines that classified it as a medical device.
For instance, the new guidance indicates that software predicting a patient’s risk for future cardiovascular events based on factors like weight, smoking status, blood pressure, and lab results would not be subject to FDA enforcement. However, if the same software aimed to predict risk within a 24-hour timeframe or used genomic data, it would still be classified as a medical device.
Additionally, the guidance addresses the use of software to summarize findings from radiologists, especially in the context of generative artificial intelligence. A function that analyzes a radiologist’s report to produce a summary with specific diagnostic recommendations would be exempt. In contrast, if the software directly analyzed an image to generate the report, it would remain under FDA regulation.
The guidance also specifies the information that device manufacturers must provide to clinicians for reviewing the basis of the software’s recommendations. Software designed for critical and time-sensitive tasks will still be classified as a medical device, requiring companies to furnish a description of the underlying algorithm, validation processes, and necessary input information, as stated by the FDA.
Implications of the New Guidelines
The issuance of these guidance documents reflects the Trump administration’s deregulatory approach to artificial intelligence in healthcare. Over recent months, the administration has advocated for reduced regulations, although specifics have been sparse. In December, the Department of Health and Human Services solicited feedback from the healthcare sector on how to facilitate the adoption of AI technologies. Both guidance documents were released without a public comment period, aligning with the recent trend of the Trump administration to implement major policy changes.