Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators
fda-device · Food and Drug Administration · Rule · Published 2026-04-16 · Effective 2026-05-18 · 91 FR 20352
Document
Document number
2026-07366
Federal Register citation
91 FR 20352
CFR reference
21 CFR 890
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2026-04-16
Effective date
2026-05-18
HHS docket
Docket No. FDA-2020-N-1053
Abstract
The Food and Drug Administration (FDA) is issuing a final order to reclassify non-invasive bone growth stimulators (product codes LOF and LPQ), postamendments class III devices, into class II, subject to premarket notification. FDA is codifying the reclassification of these devices under the new classification regulation, "non-invasive bone growth stimulator." FDA is also establishing the special controls necessary to provide reasonable assurance of safety and effectiveness of these devices.