Quick Answer: On 6 January 2026, FDA issued two revised final guidance documents covering digital health: a new Clinical Decision Support Software guidance and a new General Wellness: Policy for Low Risk Devices guidance, both replacing older versions and both framed by Commissioner Marty Makary as cutting unnecessary regulation [1, 6]. Both are described on FDA's own Digital Health Center of Excellence pages as part of its broader digital health policy framework [2, 3]. The General Wellness update is the more consequential one for wearables specifically: it reverses a position FDA had taken as recently as September 2025, now allowing non-invasive wearables to claim blood pressure and other physiological outputs under general wellness, provided the claims stay strictly wellness-focused [7]. That reversal isn't theoretical. In June 2026, FDA formally closed a warning letter it had issued to wearable maker WHOOP over its Blood Pressure Insights feature, citing the new guidance directly [8, 9]. The CDS update adds a genuinely new enforcement discretion policy for software giving a single clinically appropriate recommendation, which we've covered in full separately. Neither guidance changes FDA's underlying legal authority — both are explicit that guardrails remain for anything making disease-specific or diagnostic claims.
The WHOOP story is the clearest proof this is real
The warning letter
On 24 June 2025, HHS Secretary Robert F. Kennedy Jr. told a House Energy and Commerce subcommittee he wanted Americans making broader use of wearables like the Apple Watch, Oura Ring, and WHOOP, saying wearables let people "take control over their own health" [10]. Less than a month later, on 14 July 2025, FDA sent WHOOP a warning letter [4]. It stated the company's Blood Pressure Insights feature was an adulterated, misbranded medical device, marketed without clearance, because a blood pressure estimation is "inherently associated with the diagnosis of hypo- and hypertension" and therefore not eligible for the general wellness exemption. WHOOP publicly disagreed the next day. FDA doubled down in September, issuing safety communications naming smartwatches and smart rings specifically and stating that blood-pressure-estimating wearables "do not fall within the FDA's policy for general wellness products" [7].
The reversal
The January 2026 General Wellness guidance reversed that exact position. It now states that non-invasive wearables estimating physiological parameters, including blood pressure, can qualify as general wellness products if the intended use stays strictly wellness-focused and the product meets the guidance's other conditions [7]. On 17 June 2026, FDA sent WHOOP a formal closeout letter: "Based on changes your firm has made to your 'Blood Pressure Insights' product and its labeling in response to our Warning Letter dated July 14, 2025, and consistent with the Food and Drug Administration's updated guidance document, General Wellness: Policy for Low Risk Devices, FDA does not intend to enforce the device statutory and regulatory requirements for your BPI product as modified" [8, 9, 11]. Just over eleven months from warning letter to closeout, and the guidance that closed it didn't exist when the letter was sent.
That's the difference between a policy announcement and an operative rule. This one has already been tested against a real product and a real company.
What actually changed, category by category
| General Wellness | Clinical Decision Support | |
|---|---|---|
| Governs | Consumer-facing wellness products and wearables | Software recommendations to healthcare professionals |
| Core mechanism | Enforcement discretion for low-risk, wellness-only claims | Statutory exclusion under four criteria, plus new enforcement discretion |
| What's new | Wearables can claim physiological outputs (blood pressure, etc.) under wellness use | Single-recommendation software can qualify if it fails only the "one option" test |
| Still regulated | Any disease-specific, diagnostic, or treatment claim | Patient-facing CDS; time-critical alerts; anything failing the input or transparency criteria |
| Best for | Manufacturers building consumer wearables and health apps | Manufacturers building HCP-facing decision tools, including AI/ML-based ones |
General Wellness: what actually moved
The 2026 guidance replaces the 2019 version and keeps the same two-part test — a product must be intended solely for general wellness use and present low risk — but genuinely widens what counts as low risk for non-invasive wearables specifically [7]. It adds three new illustrative examples covering wearables that output multiple biomarkers like sleep, pulse rate, and blood pressure, where the earlier version offered none in that category [7]. Products that are invasive, implanted, or use higher-risk technology like lasers or radiation are explicitly outside the policy regardless of the update.
Clinical Decision Support: what actually moved
We've covered this in full detail separately, since it's dense enough to deserve its own treatment: what changed in FDA's CDS guidance, including the new enforcement discretion policy for single-answer recommendations, FDA's clarified definitions of "signal" and "pattern," and how the criteria apply to AI and LLM-based tools specifically.
Why both moved on the same day, and what didn't move
Commissioner Makary framed both updates as part of a broader push to "adapt with the times" on AI and digital health, announced publicly at CES in January 2026, with plans reportedly underway for a new, more permissive AI regulatory framework [6]. Both guidances were also issued without a public comment period, which multiple law firms tracking the space flagged as unusual given the substance of the changes [1].
Read the limits carefully, because several firms covering this have flagged real ambiguity that remains. FDA has not clarified what specific physiological ranges count as "appropriate for general wellness use" for a given parameter, leaving genuine judgment calls for products near the boundary. Neither guidance changes FDA's statutory authority: a product or software function crossing into disease-specific, diagnostic, or treatment territory is regulated exactly as it was before 6 January. The deregulatory framing describes an interpretation shift, not new law.
What this means depending on what you're building
If you're building a consumer wearable or wellness app, the General Wellness update is your governing document, and the WHOOP resolution is the clearest evidence of where the line now sits: physiological outputs are fine under strictly wellness-focused claims; anything that reads as diagnostic isn't. If your product's classification status has been genuinely unclear, confirming whether your app needs FDA clearance is worth doing directly against the current guidance rather than an assumption based on the 2019 version.
If you're building software that gives recommendations to clinicians, start with the CDS exemption criteria, particularly if your tool uses AI or machine learning, where the transparency requirement under Criterion 4 tends to be the hardest to satisfy.
If your product is already a device regardless of these exemptions, the digital-health-specific requirements layer on top of standard device obligations: SaMD classification determines your pathway, cybersecurity requirements apply throughout the product lifecycle, and if your team uses AI tools in the development process itself, that's governed separately under ISO 13485 from whether your output is a device.
Working out which of these categories your specific product actually falls into, rather than assuming based on a competitor's positioning or an outdated guidance version, is exactly the kind of classification call worth getting an outside read on before you build a compliance program around an assumption.
Common mistakes
Assuming the deregulatory framing means fewer FDA requirements generally. Both guidances are narrow, interpretive shifts on existing exemptions, not new statutory relief. Devices remain devices.
Treating the WHOOP outcome as a blanket rule for all wearables. FDA's closeout letter is explicit that it applies to WHOOP's product as modified, not to wearables generally. Your specific claims and labeling still have to independently meet the guidance's conditions.
Missing that CDS and General Wellness are separate frameworks for separate audiences. A tool giving recommendations to clinicians is a CDS question. A consumer-facing wearable is a General Wellness question. Confusing which one applies to your product leads to analyzing it against the wrong test entirely.
Assuming ambiguity resolved in your favor by default. FDA has explicitly said it hasn't defined specific "appropriate" physiological ranges for general wellness claims. Products near that boundary carry real, undefined risk either way.
Frequently asked questions
What changed in FDA's digital health regulations in 2026? On 6 January 2026, FDA issued revised final guidance on Clinical Decision Support Software and on General Wellness: Policy for Low Risk Devices. The CDS update adds enforcement discretion for software giving one clinically appropriate recommendation. The General Wellness update allows non-invasive wearables to claim physiological outputs, including blood pressure, under wellness use, reversing FDA's 2025 enforcement stance on the same question.
Did FDA change its position on wearable blood pressure monitors? Yes. FDA issued a warning letter to WHOOP in July 2025 stating blood pressure estimation was inherently diagnostic and not eligible for the general wellness exemption, then reversed that position in its January 2026 guidance, and formally closed the WHOOP warning letter in June 2026 citing the new guidance directly.
Is my wearable device now exempt from FDA regulation? Only if it's intended solely for general wellness use, presents low risk, and avoids disease-specific, diagnostic, or treatment claims. The January 2026 update widens what counts as low risk for physiological outputs like blood pressure, but any product making disease-specific claims remains regulated exactly as before.
Does the General Wellness update apply to clinical decision support software? No. They're separate frameworks. General Wellness governs consumer-facing wellness products. CDS governs software that supports healthcare professionals' clinical decisions. A product can be relevant to both if it has functions in each category.
Why did FDA issue both guidances on the same day without public comment? FDA did not state a specific reason for skipping the comment period, which several law firms tracking the guidance flagged as unusual given the substance of the changes. Commissioner Makary framed both as part of a broader effort to reduce regulatory friction for AI and digital health products.
Does this mean FDA is deregulating digital health broadly? No. Both guidances are interpretive updates to existing exemption frameworks, not changes to FDA's underlying statutory authority. Products and software functions that were devices before 6 January 2026 remain devices; only the boundary of specific exemptions moved.
What is the difference between a device and a general wellness product? A general wellness product is intended solely for maintaining or encouraging a healthy lifestyle, unrelated to diagnosing, treating, curing, mitigating, or preventing a disease or condition, and presents low risk to users. A device makes or supports disease-specific, diagnostic, or treatment claims, regardless of how it's marketed.
How do I know if my digital health product needs FDA clearance? Start by identifying which framework applies: General Wellness if your product is consumer-facing and wellness-oriented, CDS if it gives recommendations to healthcare professionals, or standard device classification if neither exemption applies. Each has its own specific test, and getting the framework wrong before analyzing your product against it is the most common early mistake.
Key takeaways
The General Wellness reversal is proven, not just announced. FDA's closure of the WHOOP warning letter, citing the new guidance by name, is direct evidence the policy shift is operative, not aspirational.
CDS and General Wellness are separate tests for separate audiences. Consumer wearables and clinician-facing software are evaluated under entirely different frameworks, even when the underlying product involves similar technology.
Neither update changes FDA's statutory authority. Both are framed as deregulatory, and both explicitly preserve full oversight over disease-specific and diagnostic claims.
Real ambiguity remains at the boundary. FDA hasn't defined specific physiological ranges considered "appropriate" for general wellness claims, which several law firms have flagged as a live risk for products near that line.
Which framework applies to you depends on your audience, not your technology. The same underlying sensor or algorithm can be a general wellness question or a CDS question depending entirely on who the output is for.
Complizen helps international medical device manufacturers reach FDA 510(k) clearance, combining a software platform for in-house regulatory teams with full-service consultancy for teams without in-house FDA expertise.
If it's genuinely unclear which exemption, if any, applies to your product, that classification call is worth getting in writing before you build a go-to-market plan around an assumption. Complizen's free Gap Assessment maps your specific product against FDA's current digital health framework, including a recommended pathway if clearance turns out to be required. Request your Gap Assessment →
References
- King & Spalding — FDA Updates General Wellness and Clinical Decision Support Guidance Documents (secondary source; legal analysis). https://www.kslaw.com/news-and-insights/fda-updates-general-wellness-and-clinical-decision-support-guidance-documents
- FDA — What is Digital Health? https://www.fda.gov/medical-devices/digital-health-center-excellence/what-digital-health
- FDA — Ask a Question About Digital Health Regulatory Policies. https://www.fda.gov/medical-devices/digital-health-center-excellence/ask-question-about-digital-health-regulatory-policies
- FDA — Warning Letter, WHOOP, Inc., MARCS-CMS 709755, 14 July 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/whoop-inc-709755-07142025
- Arnold & Porter — FDA Warning Letter to Fitness Wearable Sponsor Signals Increased Agency Focus on General Wellness Products (secondary source; legal analysis). https://www.arnoldporter.com/en/perspectives/advisories/2025/09/fda-warning-letter-to-fitness-wearable-sponsor
- Ropes & Gray — FDA Adapts with the Times on Digital Health: Updated Guidances on General Wellness Products and Clinical Decision Support Software (secondary source; legal analysis). https://www.ropesgray.com/en/insights/alerts/2026/01/fda-adapts-with-the-times-on-digital-health-updated-guidances-on-general-wellness-products
- Covington & Burling — FDA Issues Revised Guidance on General Wellness Products (secondary source; legal analysis). https://www.cov.com/en/news-and-insights/insights/2026/01/fda-issues-revised-guidance-on-general-wellness-products
- MobiHealthNews — FDA closes warning letter to Whoop for blood pressure insights feature. https://www.mobihealthnews.com/news/fda-closes-warning-letter-whoop-blood-pressure-insights-feature
- MedTech Dive — FDA drops Whoop warning letter over blood pressure feature. https://www.medtechdive.com/news/fda-drops-whoop-warning-letter-over-blood-pressure-feature/823652/
- Fox News — RFK Jr to encourage Americans to use 'wearable' tech to track their health (reporting on the 24 June 2025 House Energy and Commerce Subcommittee on Health hearing). https://www-ak-ms.foxnews.com/health/rfk-jr-encourage-americans-use-wearable-tech-track-health.print
- FDA — Close-Out Letter, WHOOP, Inc., MARCS-CMS 709755, 17 June 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/whoop-inc-709755-06172026