Medical Devices; Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiology
Ensure adjunctive pain measurement devices meet FDA class II special controls as of 2026-06-01.
- Effective: June 1, 2026 — Rule effective on publication date
§ 01 Summary
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.
§ 02 Why this matters
The rule creates binding class II special controls for manufacturers of adjunctive pain measurement devices for anesthesiology and codifies the classification. Manufacturers must design, test, label, and submit these devices consistent with the applicable class II controls before marketing.
§ 03 Topics
§ 04 Affected entities
- agency: FDA
- agency: HHS
- industry: medical-device-manufacturers
- industry: anesthesiology-device-manufacturers
- statute: FDCA
§ 05 Matching feeds
§ 06 Source document
Read the full Federal Register entry on federalregister.gov.
Show classifier input (what GPT-5.5 saw)
Type: Rule Agencies: Health and Human Services Department; Food and Drug Administration Citation: 91 FR 32340 Title: Medical Devices; Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiology Abstract: The Food and Drug Administration (FDA) is classifying the adjunctive pain measurement device for anesthesiology 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 adjunctive pain measurement device for anesthesiology. 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.
Classified Jun 3, 2026 by gpt-5.5. Fetched Jun 2, 2026.
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