The FDA released updates to two guidance documents on January 6: General Wellness: Policy for Low Risk Devices (General Wellness) and Clinical Decision Support Software (CDS). FDA did not issue a traditional press release; instead, FDA Commissioner Makary took to social media to announce the updates in a video, in which he touted them as “promot[ing] more innovation with AI and medical devices” and that FDA has “a clear lane for medical grade products,” but needs “to adapt with the times and be proactive with guidance.” Consistent with the Commissioner’s messaging, the updates to the General Wellness guidance expand the types of products that qualify for enforcement discretion (i.e., do not need to comply with FDA’s device requirements). The updates to the CDS guidance, however, do not appear to significantly modify FDA’s interpretation of the CDS exemption. Nonetheless, these updated guidance documents signal FDA leadership’s willingness to ease regulatory burdens for digital health and wearables.
General Wellness Guidance Shifts FDA’s Position for Certain Physiological Parameters
The General Wellness guidance sets forth FDA’s enforcement discretion policy for general wellness devices, which includes products that (1) are intended solely for general wellness uses and (2) present only a low risk. Products that meet both these criteria are subject to FDA enforcement discretion, meaning FDA does not require such products to comply with its medical device regulations. Further, software-only products intended solely for general wellness uses (as described in the guidance) are exempt from FDA oversight per a statutory exemption added under the 21st Century Cures Act.
In the newly updated guidance, FDA added language allowing products that measure blood pressure and blood glucose data to be considered general wellness in some cases.
Specifically, per the updated guidance products that use “non-invasive sensing . . . to estimate, infer, or output physiologic parameters (e.g., blood pressure, oxygen saturation, blood glucose, heart rate variability)” may qualify as general wellness products provided that such products
- are non-invasive and not-implanted;
- do not involve an intervention or technology that may pose a risk to the safety of users or other persons if specific regulatory controls are not applied;
- are not intended for diagnosis, cure mitigation, prevention, or treatment of a disease or condition;
- are not intended to substitute for an FDA-authorized, cleared, or approved device;
- do not include claims, functionality, or outputs that prompt or guide specific clinical action or medical management; and
- do not include values that mimic those used clinically, unless validated (e.g., manufacturer testing, peer-reviewed clinical literature) to reflect those values.
This new language marks a significant policy shift for products that measure blood pressure and blood glucose. While FDA has long recognized that products intended to measure oxygen saturation and heart rate may qualify as general wellness, it previously considered products that measure or estimate blood pressure and blood glucose to be regulated medical devices requiring premarket review because it considered the measurement of these parameters to be intrinsically related to the diagnosis of disease or other medical conditions (i.e., hypertension and diabetes).
The updates to the General Wellness guidance provide digital health developers a new option for expanding their offerings into the blood pressure and blood glucose area with much less onerous FDA oversight.
CDS Guidance Maintains FDA’s Narrow Interpretation
The CDS guidance details FDA’s interpretation of the statutory exemption for clinical decision support software, including its current thinking on the four statutory criteria that must be met to qualify for this exemption.
To be exempt, the software must meet all of the following criteria: (1) not intended to acquire, process, or analyze medical images, signals, or patterns; (2) intended to display, analyze, or print medical information; (3) intended to provide recommendations to a health care professional (HCP) about prevention, diagnosis, or treatment of a disease or condition; and (4) intended for the purpose of enabling the HCP to independently review the basis of such recommendations so that it is not the intent that the HCP primarily rely on any recommendations to make a clinical diagnosis or treatment decision.
Although FDA made changes in the updated CDS guidance to its interpretation of each of these criteria, the updated guidance does not represent a significant shift in FDA’s longstanding interpretation of the statutory exemption.
The most notable update is that FDA intends to exercise enforcement discretion for CDS that provides a single recommendation when clinically appropriate, provided that all the other exemption criteria are met. Previously, FDA had expressed that software providing a single recommendation could not qualify for the exemption. The updated guidance also removes this restriction and its accompanying discussion.
While this change may appear significant on its face, it largely reflects existing FDA practice. FDA had been granting case-by-case enforcement discretion for certain software that provided a single recommendation. Ultimately, this alignment between the guidance and FDA practice is not a substantive change to FDA’s overall approach, but it does provide transparency to digital health developers and may provide assurance to industry that it is possible to develop such single-recommendation products with less concerns about FDA regulatory oversight.
Other changes in the updated CDS guidance also do not meaningfully shift FDA’s established interpretation. For example, FDA clarifies that “medical patterns” exclude discrete physiological measurements (e.g., routine vital signs), and that “medical information about a patient” includes information used in the clinical care of the patient that provide some additional guidance, but these additions do not significantly modify FDA’s existing interpretation.
Similarly, while FDA condensed and relocated its discussion of “automation bias” and “time critical clinical decision making” to a different criterion, this results in no meaningful change to the types of software that FDA considers eligible for the exemption. When designing their software, digital health developers should be aware of FDA’s focus on these factors particularly if their business strategy relies on remaining outside of FDA’s regulatory oversight.
Conclusion
While the updates are aimed at deregulation for digital health technology, the largest impact of these changes will be on wearables. We expect that the implementation of these updated policies will likely evolve over time, and FDA may continue to revise its policies to further promote the development of innovative digital health technologies. We will continue to closely monitor these developments.
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Morgan Lewis guides and provides strategic counseling for life science companies, assisting them in assessing, anticipating, and navigating regulatory and legal changes, with broad experience in the regulation of medical devices, digital health, and artificial intelligence at both the state and federal levels.