Federal Register #2026-07366

FDA Reclassifies Non-Invasive Bone Growth Stimulators to Class II Devices

The Food and Drug Administration (FDA), under the Department of Health and Human Services, is reclassifying non-invasive bone growth stimulators from class III to class II medical devices. - Government Buyer: - Food and Drug Administration (FDA), Center for Devices and Radiological Health - Products/Services Requested: - Non-invasive bone growth stimulators (product code 890.5870) - Devices provide stimulation through electrical, magnetic, or ultrasonic fields - Intended for external use to promote osteogenesis as an adjunct to fracture fixation, spinal fusion, or treatment of nonunions/failed fusions - Unique or Notable Requirements: - Devices must meet special controls, including: - Clinical data demonstrating fusion - Non-clinical performance testing for safety and reliability - Biocompatibility and electrical safety - Software validation - Labeling comprehension testing - Devices now subject to 510(k) premarket notification instead of premarket approval, reducing regulatory burden - OEMs and Vendors: - No specific OEMs or vendors are named in the announcement - Purpose: - Facilitate market access for these devices while maintaining safety and effectiveness standards

Description

The Food and Drug Administration (FDA) has issued a final order to reclassify non-invasive bone growth stimulators, previously class III devices, into class II. This reclassification subjects these devices to premarket notification and establishes special controls to ensure their safety and effectiveness. The change aims to reduce regulatory burdens, allowing manufacturers to submit a 510(k) premarket notification instead of a more stringent premarket approval, potentially expediting market access. The final rule is effective May 18, 2026, and includes detailed requirements for clinical and non-clinical performance testing.

View original listing