Federal Register: final rule
Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablation
Federal Register published "Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablation" on 2026-10-06. First seen on Kresmion 2026-10-26 18:25 UTC.
The record
- Publisher
- Federal Register
- Agency
- Health and Human Services Department; Food and Drug Administration
- Source
- Federal Register
- Kind
- Federal Register: final rule
- Jurisdiction
- United States
- Topics
- Health
- Importance
- Notable, the middle of three tiers Kresmion sets by fixed rules from the source's own fields
- Published (source time)
- 2026-10-06 (the source gives a date only)
- First seen on Kresmion
- 2026-10-26 18:25 UTC
The original
Open the original on www.federalregister.govLink not checked yet: one check due 2026-11-25 (the source published this record more than 7 days before Kresmion first saw it).
Source: Federal Register (federalregister.gov). U.S. government work, public domain.
The publisher's summary
The Food and Drug Administration (FDA) is classifying the focused ultrasound system for non-thermal, mechanical tissue ablation 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 classification of the focused ultrasound system for non-thermal, mechanical tissue ablation. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the 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.
The publisher's words, as published.
Federal Register document
- Document number
- 2026-20440
- Document type
- Rule
- Status
- Published
Cite this data
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Upstream: Federal Register
Kresmion, "Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablation", data as of 2026-10-06, https://kresmion.com/record/6742. Upstream data: Federal Register.
Link to this data (HTML):
<a href="https://kresmion.com/record/6742">Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablation (Kresmion)</a>