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Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablation
Health and Human Services Department; Food and Drug Administration: final rule. Dated 29 days ago, it is in the active follow-up window. Score 30/100. As of 2026-11-03, from Federal Register API (Office of the Federal Register).
Data as of · Compiled by Zalwin from Federal Register API (Office of the Federal Register)
Free preview: all 9 published fields of this record are shown below. Locked: 62 related FederalRegisterCompliancePulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Agency | Health and Human Services Department; Food and Drug Administration |
| Type | Final rule |
| Action | Final amendment; final order. |
| Published | 2026-10-06 |
| Effective | 2026-10-06 |
| Significant | No |
| CFR parts | 21 CFR 878 |
| 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 |
| Document number | 2026-20440 |
| Peer records CSV (63 records) | 🔒 Click to unlock → |
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- Source agency: Federal Register API (Office of the Federal Register)
- Record date: 2026-10-06
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: Federal Register API (Office of the Federal Register) · Last refreshed: Tue, 03 Nov 2026 19:10:06 GMT
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Peer benchmark and outreach value: Health and Human Services Department; Food and Drug Administration and 63 food-and-drug-administration peers
- food-and-drug-administration FederalRegisterCompliancePulse records like this one: 63
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every food-and-drug-administration peer: $12,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Action Urgency Score
- Final rule.
What is the FederalRegisterCompliancePulse record for Health and Human Services Department; Food and Drug Administration?
Health and Human Services Department; Food and Drug Administration published a final rule on 2026-10-06, effective 2026-10-06: Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablation.
How does Health and Human Services Department; Food and Drug Administration compare to other FederalRegisterCompliancePulse records?
It is 29 days old, still within a typical 45-day follow-up window. Its Action Urgency Score of 30/100 is modest; treat it as background rather than a priority.
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