Static export generated 2026-07-31 07:45Z from the private Meridian research build — every value keeps its own as-of timestamp and provenance label; search, filters and admin actions are inactive in this copy. Private academic review only — not for redistribution.
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 identifier2026-13139
TitleMedical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis
AuthorityHealth and Human Services Department
JurisdictionUS
Typerule
Legal stagepublished
Publication date2026-06-30
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/2026/06/30/2026-13139/medical-devices-general-and-plastic-surgery-devices-classification-of-the-skin-patch-for-treatment
Summary (as published)The Food and Drug Administration (FDA) is classifying the skin patch for treatment of hyperhidrosis 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 skin patch for treatment of hyperhidrosis. 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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