2026-22589·DEPARTMENT OF HEALTH AND HUMAN SERVICES

Medical Devices; Orthopedic Devices; Classification of the Wearable Vibration Device for Orthopedic Use

Final RuleEffective

Published: Nov 5, 2026
Effective: Nov 5, 2026
Citation: 91 FR 69692
Docket: Docket No. FDA-2026-N-12211
Agencies: DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final amendment; final order.

Summary

The rule places wearable vibration devices that are used for orthopedic purposes—such as helping with bone healing or joint support—into the FDA’s “Class II” category. Class II devices must meet specific “special controls” (e.g., performance standards, labeling requirements) that the agency believes will ensure they are safe and effective while still allowing innovative products to reach patients more quickly. The regulation is issued by the U.S. Food and Drug Administration, the health‑agency arm of the Department of Health and Human Services. It applies to manufacturers, importers, and distributors of wearable vibration devices intended for orthopedic use, as well as to health‑care providers and patients who use these products. The final rule was published in the Federal Register on November 5, 2026, and became effective the same day. Because this is a final amendment, there is no further public comment period. Manufacturers must now comply with the newly identified special controls when seeking FDA clearance or when marketing these devices, and the FDA will enforce the classification as part of its ongoing device oversight.

AI-generated summary — verify against the Federal Register text.

Official abstract

The Food and Drug Administration (FDA) is classifying the wearable vibration device for orthopedic use 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 wearable vibration device for orthopedic use. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the 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.