Data / Federal rules / 2026-07367
Medical Devices; Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant
The Food and Drug Administration published this final rule in the Federal Register on April 16, 2026. It took effect on April 16, 2026.
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What the agency says
The Food and Drug Administration (FDA, the Agency, or we) is classifying the manual surgical instrument for appropriate patient selection for orthopedic implant 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 the classification of the manual surgical instrument for appropriate patient selection for orthopedic implant. 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.
Key facts
- Document number
- 2026-07367
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- April 16, 2026
- Takes effect
- April 16, 2026
- Dates
- This order is effective April 16, 2026. The classification was applicable on May 28, 2019.
- Docket
- Docket No. FDA-2026-N-2887
- Code of Federal Regulations
- 21 CFR 888
- Topics
- Medical devices
- Pages
- 3
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.