Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments
Details
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- Title
- Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments
- Posted
- May 1, 2026
- Comment period
- May 1, 2026 – Jul 1, 2026
- FR Doc
- 2026-08499
Overview
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Stance breakdown
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Comments over time
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Issues raised
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Position map
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Issues shown
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| Organization | Exemption framework scope and flexibility | Oral fluid and hair testing | Oral fluid testing certification |
|---|
3 organization-typed comments could not be identified.
Explorer
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- Jun 30, 2026Comment from Impact Employee SolutionsSupportIndividualRead comment →
- Jun 30, 2026Comment from Offshore Marine Service Association (OMSA)Analysis pending📎 AttachmentRead comment →
- Jun 30, 2026Comment from The American Waterways OperatorsAnalysis pending📎 AttachmentRead comment →
- Jun 30, 2026Comment from Chris VSupportIndividual
The commenter supports the proposed rule to exempt certain class II clinical toxicology test system devices from 510(k) requirements. They argue that this exemption is necessary to allow for oral fluid drug testing, which provides a necessary alternative for workers with paruresis who cannot comply with urine collection requirements.
Read comment → - Jun 30, 2026Comment from Truckload Carriers AssociationAnalysis pending📎 AttachmentRead comment →
- Jun 30, 2026Comment from The American Trucking AssociationsAnalysis pending📎 AttachmentRead comment →
- Jun 30, 2026Comment from i3screenAnalysis pending📎 AttachmentRead comment →
- Jun 30, 2026Comment from Air Line Pilots Association, InternationalAnalysis pending📎 AttachmentRead comment →
- Jun 30, 2026Comment from Intermodal Association of North AmericaAnalysis pending📎 AttachmentRead comment →
- Jun 29, 2026Comment from Passenger Vessel AssociationAnalysis pending📎 AttachmentRead comment →