Federal Register #FDA-2026-N-5825

FDA Classifies Three Medical Device Types into Class II with Special Controls

This regulatory action from the Food and Drug Administration (FDA), part of the Department of Health and Human Services, classifies three types of medical devices into class II with special controls: - Government Buyer: - Food and Drug Administration (FDA), Center for Devices and Radiological Health - OEMs and Vendors: - Medasense Biometrics Ltd. is specifically named as an OEM for adjunctive pain measurement devices - Products/Devices Classified: - Real-time ultrasound anatomy visualization and labeling devices for ultrasound guided regional anesthesia - Part number: 868.1980 - Provides real-time interpretation and enhanced visualization of live ultrasound images for regional anesthesia - Adjunctive pain measurement devices for anesthesiology - Part number: 868.2200 - Includes software algorithms and hardware sensors to analyze physiological data and measure pain response in anesthetized patients - Medasense Biometrics Ltd. is highlighted as a manufacturer - Intraoral cooling devices - Part number: 21 CFR Part 872 - Used for dental applications to provide intraoral cooling - Unique or Notable Requirements: - All devices require clinical and non-clinical performance testing, human factors testing, software verification and validation, biocompatibility, electrical safety, electromagnetic compatibility, and specific labeling - The classification is intended to ensure safety and effectiveness while reducing regulatory burdens and improving patient access to innovative devices - No procurement, purchase quantities, or solicitation actions are included; this is a regulatory classification action, not a purchasing opportunity

Description

The Food and Drug Administration (FDA) is classifying the adjunctive pain measurement device for anesthesiology into class II with special controls. This device includes software algorithms to analyze physiological sensor data and measure response to painful stimuli in patients under general anesthesia. It is intended for adjunctive use to tailor analgesic administration and is not meant to independently direct decision-making. The classification aims to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens and enhancing patient access to innovative devices.

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