Medical Devices; Orthopedic Devices; Classification of the Wearable Vibration Device for Orthopedic Use
Key claim: The FDA has classified wearable vibration devices for orthopedic use into Class II, establishing special controls to ensure safety and effectiveness while enabling future manufacturers to seek market clearance via the 510(k) pathway.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) 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.
Why this matters
This final FDA classification establishes device-specific special controls and a 510(k) clearance pathway for future wearable vibration devices for orthopedic use. For patients and providers, it defines the regulatory requirements for these devices rather than changing insurance coverage or patient cost-sharing.