FDA Classifies Intraoperative Surgical Angle Measurement Tool As Class II Device
July 25, 2026
July 25, 2026
WASHINGTON, July 25 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued a final order classifying intraoperative surgical angle measurement tools into class II with special controls.
This regulatory action amends 21 CFR Part 888 and became applicable on July 14, 2023. The agency determined that establishing class II general and special controls provides a reasonable assurance of device safety and effectiveness. By taking this administrati . . .
This regulatory action amends 21 CFR Part 888 and became applicable on July 14, 2023. The agency determined that establishing class II general and special controls provides a reasonable assurance of device safety and effectiveness. By taking this administrati . . .