Data / Federal rules / 2026-07366
Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators
The Food and Drug Administration published this final rule in the Federal Register on April 16, 2026. It took effect on May 18, 2026.
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What the agency says
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.
Key facts
- Document number
- 2026-07366
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- April 16, 2026
- Takes effect
- May 18, 2026
- Dates
- This order is effective May 18, 2026.
- Docket
- Docket No. FDA-2020-N-1053
- Code of Federal Regulations
- 21 CFR 890
- Topics
- Medical devices
- Pages
- 11
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on medical devices · Published in April 2026
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.