FDA relaxes oversight of general wellness devices, CDS software

In a move meant to bolster the adoption of artificial intelligence (AI)-enabled digital health products, the US Food and Drug Administration (FDA) on Tuesday updated two guidances to ease its oversight of general wellness devices and clinical decision support (CDS) software.

The agency said that the changes will provide product developers with more flexibility and predictability in bringing products to market, while ensuring that medical-grade products continue to be regulated.

The two final guidances were updated without public input and limit the types of products that would fall under the agency's regulatory oversight or require premarket authorization. FDA Commissioner Marty Makary announced the shift in policy at the Consumer Electronics Show (CES) in Las Vegas and posted a video on X.com stating that they would "promote more innovation with AI and medical devices." He also appeared on Fox Business to discuss the changes.

"Industry wants clear guidance, markets like predictability, investors want predictability, and that's what we're going to give them," said Makary. "If they're not making claims that they're medical grade, let's let the market decide, let's let doctors choose from a competitive marketplace which ones they recommend for their patients.

“Many of these AI and software-based technologies are improving over time so for us to use an old model at the FDA to simply put a rubber stamp on something isn't really appropriate for an evolving marketplace," he added.

CDS Software

FDA updated its 2022 guidance, which categorized CDS software as a medical device if there was concern about automation bias that may lead to medical errors of commission or omission.

"Automation bias is the propensity of humans to over-rely on a suggestion from an automated system," said FDA in the 2022 guidance. "In the context of CDS, automation bias can result in errors of commission (following incorrect advice) or omission (failing to act because of not being prompted to do so).

"Automation bias may be more likely to occur if software provides a user with a single, specific, selected output or solution rather than a list of options or complete information for the user to consider," the guidance added. "In the former case, the user is more likely to accept a single output as correct without taking into account other available information to inform their decision-making."

Some legal experts said that the guidance broadly overstepped the agency's statutory authority and, in essence, regulated clinical practice. They also argued that it violated the 21st Century Cures Act, which states that medical software, such as CDS software, should not be regulated as long as it is not the primary decision resource for healthcare providers (HCP). (RELATED: Industry group petitions FDA to withdraw CDS guidance, Regulatory Focus 9 February 2023)

In the updated final CDS software guidance, FDA has revised its definition of automation bias, which removes its concern that HCPs may be overly reliant on software that provides only one recommendation without providing other treatment options. Instead, the agency expanded on the four criteria that must be met for a product to be exempt from oversight. More specifically, the agency said that in situations where the CDS software is intended to provide recommendations to HCPs on preventing, diagnosing, or treating a patient, and it gives only one clinically appropriate result while meeting other requirements, the agency will use its enforcement discretion to allow the product on the market.

The guidance also provides new examples of situations where CDS software that provides one clinically appropriate recommendation would be exempt from regulatory oversight, and situations where such software would be regulated as a medical device.

General Wellness Products

FDA updated its general wellness products guidance in which it added a section stating that it may also now consider devices with non-invasive sensors, such as optical sensors, used to measure physiological factors such as blood pressure, oxygen saturation, blood glucose, and heart rate variability, as general wellness products if their output is "solely for wellness uses." The agency lists a slew of other factors the products would need to meet to be excluded as a medical device, including not involving risky interventions; not intended to diagnose, cure, mitigate, prevent, or treat a patient; and not intended to substitute an FDA-authorized, cleared, or approved product.

"Products that meet the aforementioned criteria may display values, ranges, trends, baselines, or longitudinal summaries, and may contextualize these outputs in relation to sleep, activity, stress, recovery, or similar wellness domains," said FDA. "Products are not general wellness products when they are intended to measure, estimate, or report physiologic values for medical or clinical purposes, including screening, diagnosis, monitoring, alerting, or management of a disease or condition."

The update to FDA's general wellness product guidance follows a dispute with the Boston-based wearable health technology company Whoop over the marketing of its Blood Pressure Insights (BPI) feature on its devices without obtaining approval or clearance from the agency. (RELATED: FDA warns wearable tech firm, Korean drugmaker, and sellers of Kratom-derived compound, Regulatory Focus 15 July 2025)

In July 2025, FDA issued a warning letter to Whoop stating that the company described BPI as providing "daily systolic and diastolic blood pressure estimations, offering members a new way to understand how blood pressure affects their performance and well-being." Furthermore, it stated that the feature renders it a medical device because it is advertised as "delivering medical-grade health & performance insights."

Whoop, however, argued that the feature should not be considered a medical device because it is not intended to diagnose or cure a disease or condition. It further said that it should be treated as a wellness device because it is only intended to maintain or encourage a healthy lifestyle.

FDA appears to have addressed the issue with the updated guidance. It includes additional examples of products considered general wellness products for which the agency does not intend to enforce regulatory requirements.

More specifically, FDA said that wrist-worn wearable products intended to assess activity and recovery that output multiple biomarkers, such as sleep quality, pulse rate, and blood pressure, and that do not refer to a specific disease or medical condition, would be considered general wellness products.

"In addition, the technology for monitoring these biomarkers does not pose a risk to the safety of users and other persons if specific regulatory controls are not applied," said FDA. "Therefore, this product meets both factors for a low risk general wellness product, provided the product has validated values for blood pressure.

"However, if the claims made about any of the product’s functionality implied the product’s use in a medical or clinical context, the product would not be a low risk general wellness product," the agency added.

FDA said minimally invasive blood glucose wearables used to assess nutritional impacts are also general wellness products as long as they are contraindicated for use with diabetic and pre-diabetic patients as a means of understanding their insulin response to certain foods. Similarly, the agency said that non-invasive wearable products marketed to athletes to monitor factors such as electrolyte balance, lactate, and hemoglobin are also considered general wellness products.

Updated CDS software guidance

Updated general wellness products guidance

FDA relaxes oversight of general wellness devices, CDS software

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