- Version
- 1.0
- Length
- 7 pages
Abstract
Cleared hardware is abundant; qualified digital endpoints are not. This annex is the evidence base for the series' statements about measurement hardware. It analyses 269 FDA marketing decisions for sensor-based digital health technologies (sDHTs) (279 on the list as updated by FDA on 4 September 2026; Section 4 gives the currency note) — 253 510(k) clearances, 13 De Novo grants and 3 PMA approvals with final-decision dates between 30 January 2015 and 13 March 2026, in the snapshot qointa took on 16 June 2026. Each decision is classified by regulatory pathway, sensor modality, lead review panel and inferred connectivity route. The finding is a supply-and-acceptance gap. FDA decisions for sensor-based DHTs have grown roughly fivefold in a decade, and two modalities — cardiac and neuro/sleep sensing — account for 59% of the list. Over the same period exactly one digital endpoint has been formally qualified by a regulator: stride velocity 95th centile, qualified by EMA. Hardware is not what limits digital endpoints; reusable evidence of endpoint suitability is. The practical consequence for a sponsor is that a cleared device settles nothing about whether the measure it produces will carry an endpoint — that case must be built, per program, under the framework set out in QPP-01 — Endpoint Validation and QPP-15 — Endpoint Qualification.
Contents
2. Cleared sensing is concentrated in a few modalities and a few makers; 3. One digital endpoint has been qualified; clearance did not do it; 4. This is a snapshot of FDA decisions, not a census of the market; 5. Authorization volume has grown fivefold; endpoint acceptance has not moved; 6. The measuring device is usually not the transmitting one; 7. Half the classifications are inferred and should be checked before use
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