Medical Devices; Orthopedic Devices; Classification of the Intraoperative Surgical Angle Measurement Tool
Key claim: The FDA is classifying the intraoperative surgical angle measurement tool into class II with special controls to assure safety and effectiveness while reducing regulatory burdens and improving access.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) The Food and Drug Administration (FDA) is classifying the intraoperative surgical angle measurement tool 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 intraoperative surgical angle measurement tool. 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.
Why this matters
The FDA is classifying the intraoperative surgical angle measurement tool into class II with special controls to assure safety and effectiveness while reducing regulatory burdens and improving access.