Rule2024-19868
Medical Devices; Dental Devices; Classification of the Radiofrequency Toothbrush
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 5, 2024
Effective
September 5, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is classifying the radiofrequency toothbrush 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 radiofrequency toothbrush's classification. We are taking this action because we have determined that classifying the device into class II (special controls) 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.
Full Text
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<title>Federal Register, Volume 89 Issue 172 (Thursday, September 5, 2024)</title>
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[Federal Register Volume 89, Number 172 (Thursday, September 5, 2024)]
[Rules and Regulations]
[Pages 72320-72321]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19868]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 872
[Docket No. FDA-2024-N-3973]
Medical Devices; Dental Devices; Classification of the
Radiofrequency Toothbrush
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the radiofrequency toothbrush 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 radiofrequency
toothbrush's classification. We are taking this action because we have
determined that classifying the device into class II (special controls)
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.
DATES: This order is effective September 5, 2024. The classification
was applicable on September 17, 2020.
FOR FURTHER INFORMATION CONTACT: Lauren Giles, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G309, Silver Spring, MD 20993-0002, 301-796-9552,
<a href="/cdn-cgi/l/email-protection#5b173a2e293e35751c32373e281b3d3f3a75333328753c342d"><span class="__cf_email__" data-cfemail="2e624f5b5c4b40006947424b5d6e484a4f0046465d00494158">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the radiofrequency toothbrush as
class II (special controls), which we have determined will provide a
reasonable assurance of safety and effectiveness.
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 as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 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 (see 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 application
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 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.
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
510(k) process, when necessary, to market their device.
II. De Novo Classification
On August 22, 2019, FDA received Home Skinovations Ltd.'s request
for De Novo classification of the ToothWave\TM\. 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 safety and
effectiveness, 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 21 U.S.C. 360c(a)(1)(B)). 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 September 17, 2020, 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
872.6866.\1\ We have named the generic type of device radiofrequency
toothbrush, and it is identified as a device that consists of a handle
containing a radiofrequency generator to deliver radiofrequency energy
to a brush intended to be applied to the teeth. The device is intended
to remove adherent plaque and food debris from the teeth to reduce
tooth decay.
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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 following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.
[[Page 72321]]
Table 1--Radiofrequency Toothbrush Risks and Mitigation Measures
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Identified risks to health Mitigation measures
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Thermal injury (mucosal or Non-clinical performance testing;
unintentional skin Software validation, verification, and
overheating/burn). hazard analysis; Electrical safety
testing; Electromagnetic compatibility
(EMC) testing; and Labeling.
Adverse tissue reaction...... Biocompatibility evaluation.
Mechanical injury to the oral Electrical safety testing, Non-clinical
cavity. performance testing, and Labeling.
Electromagnetic interference Electrical safety testing,
or electrical shock. Electromagnetic compatibility (EMC)
testing, Battery safety testing, and
Labeling.
Incorrect use or operation of Non-clinical performance testing,
the device causing harm or Usability evaluation, Use life testing,
injury to the user. Electrical safety testing, and Labeling.
Gingival irritation or Label comprehension and self-selection
recession, tooth sensitivity study, and Labeling.
or pain by failure to
identify correct population
and condition.
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FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. 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 order. This device is 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 individually or cumulatively 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 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 872
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
872 is amended as follows:
PART 872--DENTAL DEVICES
0
1. The authority citation for part 872 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 872.6866 to subpart G to read as follows:
Sec. 872.6866 Radiofrequency toothbrush.
(a) Identification. A radiofrequency toothbrush is a device that
consists of a handle containing a radiofrequency generator to deliver
radiofrequency energy to a brush intended to be applied to the teeth.
The device is intended to remove adherent plaque and food debris from
the teeth to reduce tooth decay.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested, and detailed
protocols must be provided for each test conducted:
(i) Validation of the radiofrequency performance specifications
including output power, voltage output, radiofrequency, pulse cycle,
waveform, and pulse duration;
(ii) Temperature performance testing to evaluate the temperature
change of the device, structures of the oral cavity (including skin,
tissue, and dental restorations), and toothpaste under worst-case
conditions;
(iii) An assessment of mechanical output specifications and
physical properties including vibration frequency, tuft retention,
brush head strength, and battery voltage; and
(iv) Use life and durability testing.
(2) A label comprehension and self-selection study must demonstrate
that the intended user population can understand the package labeling
and correctly choose the device for the indicated use.
(3) Usability performance evaluation must demonstrate that the user
can safely and correctly use the device, based solely on reading the
directions for use.
(4) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(5) Electrical safety, thermal safety, mechanical safety, battery
safety, and electromagnetic compatibility (EMC) testing must be
performed.
(6) Software verification, validation, and hazard analysis must be
performed.
(7) Labeling must include:
(i) Information on how the device operates, including images or
illustrations;
(ii) A detailed summary of the device technical specifications;
(iii) A warning which states that the use of this device is not a
substitute for regular visits to a dentist for routine clinical care;
(iv) Instructions on how to clean and maintain the device; and
(v) The use life and disposal of the components of the device.
Dated: August 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19868 Filed 9-4-24; 8:45 am]
BILLING CODE 4164-01-P
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