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topic510k-device-pathway
Federal Register documents tagged 510k-device-pathway. Each entry is scored 1-5 for compliance materiality and dated for any comment or effective-date deadlines.
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Medical Devices; Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiology
Action: Ensure adjunctive pain measurement devices meet FDA class II special controls as of 2026-06-01.
FDA classifies adjunctive pain measurement devices for anesthesiology as class II medical devices subject to special controls. The rule codifies the device type and applicable controls, moving it into a regulated pathway intended to provide reasonable assurance of safety and effectiveness while facilitating market access.
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