Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablation

Issuing agencies

Abstract

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.

Full Text

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<title>Federal Register, Volume 91 Issue 192 (Tuesday, October 6, 2026)</title>
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[Federal Register Volume 91, Number 192 (Tuesday, October 6, 2026)]
[Rules and Regulations]
[Pages 63493-63495]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20440]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2026-N-10992]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Focused Ultrasound System for Non-Thermal, 
Mechanical Tissue Ablation

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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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.

DATES: This order is effective October 6, 2026. The classification was 
applicable on October 6, 2023.

FOR FURTHER INFORMATION CONTACT: Cal Rabang, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4633, Silver Spring, MD 20993-0002, 301-796-6412, 
<a href="/cdn-cgi/l/email-protection#b2f1d3de9ce0d3d0d3dcd5f2d4d6d39cdadac19cd5ddc4"><span class="__cf_email__" data-cfemail="93d0f2ffbdc1f2f1f2fdf4d3f5f7f2bdfbfbe0bdf4fce5">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA (the Agency or we) has classified the focused 
ultrasound system for non-thermal, mechanical tissue ablation into 
class II (special controls), which we have determined will provide a 
reasonable assurance of the safety and effectiveness of the device. In 
addition, we believe this action will enhance patients' access to 
beneficial innovation, in part by

[[Page 63494]]

reducing regulatory burdens by placing the device into a lower device 
class than the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified into, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (21 U.S.C. 
360c(f)(1)). We refer to these devices as ``postamendments devices'' 
because they were not in commercial distribution prior to the date of 
enactment of the Medical Device Amendments of 1976, which amended the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that 
does not require premarket approval. We determine whether a new device 
is substantially equivalent to a predicate device by means of the 
procedures for premarket notification under section 510(k) of the FD&C 
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). 
Section 207 of the Food and Drug Administration Modernization Act of 
1997 (Pub. L. 105-115) established the first procedure for De Novo 
classification. Section 607 of the Food and Drug Administration Safety 
and Innovation Act (Pub. L. 112-144) modified the De Novo 
classification process by adding a second procedure. A device sponsor 
may utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a premarket 
notification (510(k)) for a device that has not previously been 
classified. After receiving an order from FDA classifying the device 
into class III under section 513(f)(1) of the FD&C Act, the person then 
requests a classification under section 513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
and then a request for classification, if the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence, that person requests a classification under 
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required 
to classify the device by written order within 120 days. The 
classification will be according to the criteria under section 
513(a)(1) of the FD&C Act. Although the device was automatically placed 
within class III, the De Novo classification is considered to be the 
initial classification of the device.
    We believe this De Novo classification will enhance patients' 
access to beneficial innovation, in part by reducing regulatory 
burdens. When FDA classifies a device into class I or II via the De 
Novo process, the device can serve as a predicate for future devices of 
that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the 
FD&C Act). As a result, other device sponsors do not have to submit a 
De Novo request or premarket approval application to market a 
substantially equivalent device (see section 513(i) of the FD&C Act, 
defining ``substantial equivalence''). Instead, sponsors can use the 
less burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On December 2, 2022, FDA received HistoSonics, Inc.'s request for 
De Novo classification of the Edison System. FDA reviewed the request 
in order to classify the device under the criteria for classification 
set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves 
are insufficient to provide reasonable assurance of the safety and 
effectiveness of the device, but there is sufficient information to 
establish special controls that, in combination with the general 
controls, provide reasonable assurance of the safety and effectiveness 
of the device for its intended use (see section 513(a)(1)(B) of the 
FD&C Act). After review of the information submitted in the request, we 
determined that the device can be classified into class II with the 
establishment of special controls. FDA has determined that these 
special controls, in addition to the general controls, will provide 
reasonable assurance of the safety and effectiveness of the device.
    Therefore, on October 6, 2023, FDA issued an order to the requester 
classifying the device into class II. In this final order, FDA is 
codifying the classification of the device by adding 21 CFR 
878.4405.\1\ We have named the generic type of device ``focused 
ultrasound system for non-thermal, mechanical tissue ablation,'' and it 
is identified as a device that uses focused ultrasound to mechanically 
ablate soft tissue. The device is not intended to thermally ablate 
tissue.
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    \1\ FDA notes that the ``ACTION'' caption for this final order 
is styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
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    FDA has identified the risks to health associated with this type of 
device and the measures required to mitigate these risks in table 1.

 Table 1--Risks to Health and Mitigation Measures for Focused Ultrasound
           System for Non-Thermal, Mechanical Tissue Ablation
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       Identified risks to health              Mitigation measures
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Impaired tissue or organ function,       Clinical performance testing;
 abscess, pain, or other adverse events   Labeling; and Human factors
 downstream of tissue ablation.           testing.
Acoustic path, non-targeted tissue       Clinical performance testing;
 injury.                                  Human factors testing; Animal
                                          performance testing; and Non-
                                          clinical performance testing.
Tissue injury due to device malfunction  Clinical performance testing;
 or misuse.                               Software verification,
                                          validation, and hazard
                                          analysis; Non-clinical
                                          performance testing; Labeling;
                                          and Human factors testing.
Adverse tissue reaction................  Biocompatibility evaluation.
Electrical shock or electromagnetic      Electrical safety testing;
 interference.                            Electromagnetic compatibility
                                          testing; and Labeling.
------------------------------------------------------------------------


[[Page 63495]]

    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of the safety and effectiveness of the device. For a device 
to fall within this classification, and thus avoid automatic 
classification in class III, it would have to comply with the special 
controls named in this final order. The necessary special controls 
appear in the regulation codified by this final order. FDA supports the 
principles of the ``3Rs,'' to replace, reduce, and/or refine animal use 
in testing when feasible. We encourage sponsors to consult with us if 
they wish to use a non-animal testing method they believe is suitable, 
adequate, validated, and feasible. We will consider whether such an 
alternative method could be assessed for equivalency to an animal test 
method.
    Under the FD&C Act, submission of a premarket notification under 
section 510(k) is required to reasonably assure the safety and 
effectiveness of class II devices unless FDA determines that the device 
type should be exempt under section 510(m) of the FD&C Act. At this 
time FDA has not made this determination for focused ultrasound systems 
for non-thermal, mechanical tissue ablation. This device is therefore 
subject to premarket notification requirements under section 510(k) of 
the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not normally have a significant effect on the human 
environment. Therefore, neither an environmental assessment nor an 
environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations and guidance. These collections of information are subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections 
of information in part 860, subpart D, regarding De Novo classification 
have been approved under OMB control number 0910-0844; the collections 
of information in 21 CFR part 814, subparts A through E, regarding 
premarket approval have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding 
premarket notification submissions have been approved under OMB control 
number 0910-0120; the collections of information in 21 CFR part 820 
regarding quality management system regulation have been approved under 
OMB control number 0910-0073; and the collections of information in 21 
CFR part 801 regarding labeling have been approved under OMB control 
number 0910-0485.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Add Sec.  878.4405 to subpart E to read as follows:


Sec.  878.4405   Focused ultrasound system for non-thermal, mechanical 
tissue ablation.

    (a) Identification. This device uses focused ultrasound to 
mechanically ablate soft tissue. The device is not intended to 
thermally ablate tissue.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use. Testing must 
document the adverse event profile and characterize tissue destruction.
    (2) Animal performance testing must demonstrate that the device 
mechanically destroys targeted tissue while characterizing the chronic 
safety profile, including thermal and mechanical injury to adjacent, 
non-target tissue.
    (3) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Acoustic characterization at clinically relevant settings;
    (ii) Determination of the minimum drive voltages necessary to 
sustain a bubble cloud in the target tissue;
    (iii) Validation of mechanisms to prevent energy delivery that 
would result in adverse thermal effects;
    (iv) Availability of real-time monitoring during the procedure;
    (v) Validation that the treatment zone is limited to the defined 
target tissue; and
    (vi) Validation of mechanisms to prevent, pause, and terminate 
ablation in the event of device failure.
    (4) Performance data must support the electrical safety and 
electromagnetic compatibility of the device.
    (5) All patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (6) Software validation, verification, and hazard analysis must be 
performed.
    (7) Human factors testing must demonstrate that the user can safely 
and correctly use the device.
    (8) Labeling must include the following:
    (i) A warning that focused ultrasound ablation should only be 
considered in patients with sufficient functional reserve to withstand 
the destruction of the planned volume of tissue;
    (ii) A statement that the device has not been evaluated for the 
treatment of any specific disease or condition; and
    (iii) A detailed summary of the clinical testing with the device.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20440 Filed 10-5-26; 8:45 am]
BILLING CODE 4164-01-P


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