FDA Updates Broaden Wellness and Clinical Decision Support Software Devices Under Enforcement

By Sarah Fitzgerald

Background

On January 6, 2026, the U.S. Food and Drug Administration (FDA) published updates to two guidance documents, “General Wellness: Policy for Low-Risk Devices” (General Wellness Guidance) and “Clinical Decision Support Software” (CDS Guidance). On January 7, the guidance “Software as a Medical Device (SaMD): Clinical Evaluation” (SaMD Clinical Evaluation Guidance) was withdrawn. 

The main topic for the first two guidance documents revolves around which products are medical devices that require standard FDA oversight, medical devices that are considered under enforcement discretion from the FDA, and products that are not considered medical devices. 

General wellness guidance: update summary 

While not solely about software expectations, the update to the General Wellness Guidance focuses on providing more clarity on how the FDA determines if a product is not a medical device, is a general wellness medical device under enforcement discretion, or is a medical device under the standard regulatory paradigm. The main changes appear to be in how they are considering devices that are intended to estimate physiological parameters (examples provided include blood pressure, oxygen saturation, blood glucose, heart rate variability, etc.) and wearable devices with software and expanding what can be considered a general wellness device. Essentially, the FDA emphasizes that product labeling, especially claims, is critical to determine if the product can be considered under enforcement discretion or requires standard FDA regulation. 

In alignment with the 21^st Century Cures Act of 2016, certain software functions were removed from the definition of a medical device. Specifically, software that is intended “for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention or treatment of a disease or condition” is not considered a medical device. This is not changed from the 2019 version of the guidance. 

General wellness devices are considered under enforcement discretion and the manufacturer does not need to meet general medical device requirements, including quality management system implementation, establishment registration or device listing, and premarket submission. 

General wellness guidance: criteria for general wellness device under enforcement discretion

A general wellness device must meet several criteria, which are scattered throughout this guidance document and summarized here (numbering is not per the FDA guidance, which does not state these in one location): 

1. Must be intended only for general wellness use
2. Must present a low risk of safety
3. Are intended for maintaining or encouraging a general state of health / healthy activity OR are intended to help reduce the risk or impact of certain chronic diseases or conditions, which are well understood and accepted that healthy lifestyle choices may play an important role in health outcomes.
   1. The latter shall subsequently be referenced as “living well with” a condition.
4. Are non-invasive and non-implanted
5. Do not involve an intervention or technology that may pose a safety risk if specific regulatory controls are not applied (such as radiation)
6. Are not intended to diagnose, cure, mitigate, prevent or treat a disease or condition
7. Are not intended to substitute for a standard FDA-regulated device
8. Do not include claims, functionality, or outputs that prompt or guide specific clinical action or medical management
9. Do not include values that mimic those used clinically unless validated to reflect those values
10. Do not characterize the output as abnormal, pathological, or diagnostic
11. Do not include clinical thresholds, diagnoses, or treatment recommendations
12. Do not provide ongoing alerts or monitoring intended to manage a disease or condition 

Any device that does not meet those criteria is therefore considered a device under the standard regulatory expectations. 

General wellness guidance example challenge – blood glucose devices

So let us consider the example of blood glucose devices under this paradigm, as blood glucose is one of the physiological parameters specifically mentioned. Generally, the familiar glucose test systems are Class II devices that require a 510(k) be cleared before selling and are intended to be used to periodically measure blood glucose in patients with diabetes or pre-diabetes by analyzing a small sample of blood. There are also implanted continuous glucose monitors, which are Class III and require a PMA be approved before selling. Additionally, one non-invasive blood glucose monitor has been approved as a Class III device via a PMA (P990026) as an adjunctive device to supplement information from standard glucose monitoring devices for detecting trends and tracking patterns of glucose levels and the detection and assessment of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. 

The first major challenge is to understand whether a blood glucose measuring device could be a general wellness device. Presumably, it can, because it is listed as one of the potential physiological parameters. However, the only example related to blood glucose in this guidance (Illustrative Example 8) is determined to not be a general wellness product because the example device uses a minimally invasive microneedle technology. That is a simplistic example and assessment, failing criterion 4 as it is considered invasive, above. 

What if the blood glucose device is non-invasive, only includes language about “helping to live will with diabetes,” and did not include alarms?

Here is our assessment of the major challenges to determine if such a device could be considered a general wellness device even given the FDA’s updated guidance. Criterion 7 indicates that the product cannot substitute for a standardly FDA-regulated device. The intended use for living well and as provided for the approved device are similar. Presumably, a patient would not need both. Therefore, does it meet criterion 7? 

Criterion 9 does not allow a general wellness device to provide values that mimic those used clinically unless validated, while criterion 10 does not allow a general wellness device to characterize an output as abnormal, pathologic, or diagnostic and criterion 11 does not allow clinical threshold information. 

• Generally, blood glucose measurements are provided in mg/dL. Some may provide an alert to indicate if blood glucose is outside of pre-set, clinically meaningful parameters (e.g., is “abnormal”), whether unusually high or low.
  • It is challenging to imagine a device that does not provide either a blood glucose measurement in mg/dL or indicate if it is normal or abnormally high or abnormally low. The second cannot be included per criteria 10 and 11, as that would make it not a general wellness device. Therefore, it seems that in alignment with criterion 9, presumably this device would have to be validated. However, the withdrawal of the SaMD Clinical Evaluation Guidance on January 7 (as discussed further below) makes it challenging to determine how this should be validated, especially as the FDA indicates that a general wellness device does not need to follow standard quality management system requirements. It is not clear how a company should validate this (the guidance only generally states validation could be “manufacturer testing, peer-reviewed clinical literature”). Further, there is no system for the FDA to check on this validation for general wellness devices. So what validation is sufficient? And how would sufficiency be determined? 

Therefore, it is not clear if such a non-invasive blood glucose monitor could be considered a general wellness device and, if it could, how to appropriately validate the outputs of that device. 

Therefore, while this update appears to allow more devices to be considered general wellness devices and therefore under enforcement discretion, there remain significant areas where there is a lack of clarity on where exactly the line between standard and general wellness medical devices lies. Additionally, this guidance introduces uncertainty on how to validate general wellness devices when required, especially when paired with the withdrawal of the SaMD Clinical Evaluation Guidance. 

 CDS guidance update summary 

The update to the CDS Guidance provides more clarity on how the FDA determines whether a product is a CDS medical device or non-device CDS per the 21^st Century Cures Act of 2016, and indicates which CDS medical devices would generally be considered under enforcement discretion. 

CDS guidance: Criteria for CDS

Essentially, the same four criteria are applied to determining whether a device is a CDS medical device or a non-device CDS, summarized as: 

1. Not intended to acquire, process, or analyze inputs, patterns, or signals from medical devices
2. Intended to display, analyze, or print medical information
3. Intended to support or provide recommendations to a health care professional about the prevention, diagnosis, or treatment of a disease or condition aligned with the current standard of care 
4. Intended to enable such health care professionals to independently review the basis for such recommendations and not intended to be the primary determination of a clinical diagnosis or treatment decision 

Criteria 1 and 2 remain closely aligned with the previous CDS guidance version from 2022. 

Regarding criterion 3, the FDA continues to note that if there is a single recommendation, the product would be considered a CDS medical device. However, the FDA now notes that they intend to exercise enforcement discretion over many of these devices if there is only one clinically appropriate recommendation per the current standard of care and if all other criteria are met. 

Manufacturers of devices under enforcement discretion do not need to meet most standard medical device requirements. They provide examples of devices where there is one reasonable outcome and if the FDA intends for this to be a device under enforcement discretion or standard medical device oversight. This represents a broadening of products that do not require specific FDA oversight while still being considered medical devices. 

Regarding criterion 4, the FDA continues to specifically note that products with outputs that are critical and time-sensitive are considered medical devices because it is likely that the device would be used as the primary determination of a clinical diagnosis or treatment decision (automation bias). The FDA further notes that usability testing may be required to determine if a product meets criterion 4. 

Withdrawal of the SaMD Clinical Evaluation Guidance

The withdrawal of the SaMD Clinical Evaluation Guidance the day after the update of these two guidance documents is a bit perplexing given that some devices that fall into these categories would seem to benefit from clinical evaluation guidance. Additionally, this guidance had focused on making sure that the clinical evidence is proportionate to the device’s risk. However, there are several guidance documents that cover clinical data for medical devices in general, such as the guidance “Design Considerations for Pivotal Clinical Investigations for Medical Devices,” so this does not appear to leave any significant gap in guidance related to clinical investigations overall. 

Concluding remarks

The updates to these two guidance documents appear to broaden the types of devices that can be considered under enforcement discretion, thereby representing a form of deregulation. Deregulation of lower-risk medical devices can help facilitate innovation, especially for software devices. However, even with the updated guidance documents, questions remain. 

Manufacturers should carefully consider and document their regulatory strategy (path to market). We at Emergo by UL remind manufacturers that the FDA provides the 513(g) submission process to obtain an official FDA opinion on the classification and required submission type of a medical device. Additionally, although not intended to provide classification information, a Q-submission may be used to confirm FDA expectations and would be the appropriate mechanism to discuss certain issues such as validation expectations.