FDA 510(k) clearances for chronic pain devices: regulatory trends and safety outcomes from 1976–2025
Despite shorter regulatory review, invasive chronic pain devices demonstrated substantially higher recall rates. The shift toward globally sourced noninvasive technologies reflects evolving regulatory-technological considerations.
Authors
- F. Fregni
- Bassel Almarie (ORCID: https://orcid.org/0000-0002-5409-9806)
Institutions
- Harvard University (US)
- Kantonsspital Frauenfeld (CH)
Publication Details
- Journal
- Expert Review of Medical Devices
- Published
- 2026-02-17
- DOI
- https://doi.org/10.1080/17434440.2026.2633305
- Primary Topic
- Pain Mechanisms and Treatments
- Type
- article
- Field-Weighted Citation Impact
- 0.00