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MERIDIAN Regulatory & Corporate Impact Intelligence — personal research build

Regulatory instrument

Official record

Official Regulatory Fact — text as published by the source; topics are matching candidates, not legal conclusions.

FieldValue
Canonical identifier2026-12904
TitleMedical Devices; Neurological Devices; Classification of the External Lower Extremity Nerve Stimulator for Restless Legs Syndrome
AuthorityHealth and Human Services Department
JurisdictionUS
Typerule
Legal stagepublished
Publication date2026-06-26
Discovered at2026-07-02T21:54:39Z
SR / CELEXn/a
Affected countries (parsed from title)none parsed
Matched topicsinsurance_supervision (assurance), pharma_health (medical device), food_agriculture (food)
Original sourcehttps://www.federalregister.gov/documents/2026/06/26/2026-12904/medical-devices-neurological-devices-classification-of-the-external-lower-extremity-nerve-stimulator
Summary (as published)The Food and Drug Administration (FDA) is classifying the external lower extremity nerve stimulator for Restless Legs Syndrome into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the external lower extremity nerve stimulator for Restless Legs Syndrome. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
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