PubMed

FDA 510(k)認可の慢性痛みデバイス：1976-2025年の規制トレンドと安全性の結果

PMID: 41702410 · 2026-02-20

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学術誌Expert review of medical devices

年2026-02-20

PMID41702410

抄録

We characterized regulatory and safety patterns of FDA 510(k)-cleared chronic pain devices over five decades. We analyzed 1718 chronic pain devices cleared from 1976-2025, assessing device modality, review times, recalls (2002-2025), and market concentration (Herfindahl - Hirschman Index, HHI). Most devices were noninvasive neuromodulation (1,486 [86.5%]), followed by invasive neuromodulation (162 [9.4%]), energy-based (67 [3.9%]), and digital therapeutics (3 [0.2%]). Median FDA review was 117 d

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