Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments
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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
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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 25, 2026Comment from Lifeloc Technologies Inc.SupportBusiness📎 Attachment
Lifeloc Technologies Inc., a manufacturer of alcohol breathalyzers and drug testing equipment, supports the FDA's proposal to exempt certain Class II devices from the premarket 510(k) notification process. The company argues that this change will reduce costly regulatory hurdles and benefit smaller companies by accelerating the commercialization of testing devices.
Read comment → - Jun 21, 2026Comment from Harold ChaseOtherIndividualRead comment →
- Jun 9, 2026Comment from James DodoOpposeIndividualRead comment →