---
description: January 2026 FDA guidance plus the TEMPO pilot create a two-track system where wearables reporting signals and patterns avoid medical device classification while the TEMPO pathway allows pre-authorization patient access with real-world evidence collection
type: claim
domain: health
created: 2026-02-17
source: "FDA January 2026 guidance update on CDS and general wellness; TEMPO pilot (Federal Register December 2025); Faegre Drinker analysis"
confidence: likely
---

# the FDA now separates wellness devices from medical devices based on claims not sensor technology enabling health insights without full medical device classification

The FDA's January 2026 guidance update established a critical distinction: non-invasive wearables estimating health metrics can claim general wellness status if they avoid disease/diagnostic/clinical management claims. A fitness tracker can detect "patterns and events that warrant a closer look" -- possible arrhythmia, low SpO2 -- without being classified as a medical device, as long as it reports "signals/patterns" rather than "medical information." Apple's hypertension notification exemplifies this: it does not give a blood pressure number, it flags a pattern consistent with hypertension over 30 days.

The TEMPO pilot (Technology-Enabled Meaningful Patient Outcomes, December 2025) goes further: it allows digital health device manufacturers to operate under FDA enforcement discretion while collecting real-world data. The FDA will select up to ~10 manufacturers per clinical area starting March 2026. Combined with CMS's ACCESS model, TEMPO creates a direct link between regulatory flexibility and Medicare reimbursement -- devices can reach patients BEFORE full FDA authorization.

This two-track system has structural implications. It lowers the barrier for getting wearable health technology to consumers, accelerating the shift from episodic to continuous monitoring. But it may also advantage large companies (Apple, Samsung, Dexcom, Abbott) who can navigate regulatory complexity while creating de facto barriers for innovative startups, especially in the EU where MDR certification bottlenecks are creating 13-18 month review delays.

---

### Additional Evidence (extend)
*Source: [[2025-12-05-fda-tempo-pilot-cms-access-digital-health-ckm]] | Added: 2026-03-31*

TEMPO pilot creates the next layer of FDA digital health deregulation beyond the January 2026 CDS guidance: enforcement discretion for uncleared devices deployed in real-world Medicare settings. This is a structured pathway for collecting the outcomes data that traditional FDA review requires, creating a workaround for the regulatory pathway problem where companies need data to get clearance but need clearance to collect data at scale.


Relevant Notes:
- [[continuous health monitoring is converging on a multi-layer sensor stack of ambient wearables periodic patches and environmental sensors processed through AI middleware]] -- the regulatory framework enabling the sensor stack to reach consumers
- adaptive governance outperforms rigid alignment blueprints because superintelligence development has too many unknowns for fixed plans -- TEMPO's real-world evidence approach mirrors the adaptive governance principle
- [[WHOOP subscription-only wearable model generates $260M revenue but trails Oura at half the revenue and a third the valuation because fitness-first positioning limits the addressable wellness market]] -- WHOOP MG blood pressure confrontation is the live test case for where wellness-medical boundary actually sits
- [[Oura controls 80 percent of the smart ring market with patent-defended form factor while a demographic pivot from fitness enthusiasts to wellness-focused women drives 250 percent sales growth]] -- Oura stays firmly in wellness classification, strategically avoiding the medical device boundary WHOOP crossed

Topics:
- livingip overview
- health and wellness
