[Federal Register Volume 86, Number 247 (Wednesday, December 29, 2021)]
[Rules and Regulations]
[Pages 73970-73971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28163]



[[Page 73970]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2021-N-0858]


Medical Devices; Gastroenterology-Urology Devices; Classification 
of the Transcutaneous Electrical Continence Device

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 transcutaneous electrical continence device 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 transcutaneous electrical continence device'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 December 29, 2021. The classification 
was applicable on November 6, 2018.

FOR FURTHER INFORMATION CONTACT: Purva Pandya, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4634, Silver Spring, MD 20993-0002, 240-402-9979, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the transcutaneous electrical 
continence device as class II (special controls), which we have 
determined will provide a reasonable assurance of safety and 
effectiveness. In addition, we believe this action will enhance 
patients' access to beneficial innovation, 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 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. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). 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 21 U.S.C. 360c(f)(2)(B)(i)). 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 21 U.S.C. 360c(i), defining ``substantial equivalence''). 
Instead, sponsors can use the less-burdensome 510(k) process, when 
necessary, to market their device.

II. De Novo Classification

    On September 18, 2017, FDA received Bio-Medical Research Ltd.'s 
request for De Novo classification of the INNOVO. 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 November 6, 2018, 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 
876.5330.\1\ We have named the generic type of device transcutaneous 
electrical continence device, and it is identified as a device that 
consists of cutaneous electrodes that are used to apply external 
stimulation to reduce urinary incontinence.
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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 73971]]



     Table 1--Transcutaneous Electrical Continence Device Risks and
                           Mitigation Measures
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            Identified risks                   Mitigation measures
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Pain or tissue damage due to             Non-clinical performance
 overstimulation.                         testing; Software
                                          verification, validation, and
                                          hazard analysis; Electrical
                                          safety testing; and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
Electrical shock or burn...............  Electrical safety testing;
                                          Software verification,
                                          validation, and hazard
                                          analysis; and Labeling.
Device failure due to electromagnetic    Electromagnetic compatibility
 interference.                            (EMC) testing; software
                                          verification, validation, and
                                          hazard analysis; and Labeling.
Use error that may result in user        Software verification,
 discomfort, injury, or delay in          validation, and hazard
 treatment.                               analysis; and Labeling.
------------------------------------------------------------------------

    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. In order 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 the guidance document ``De Novo Classification 
Process (Evaluation of Automatic Class III Designation)'' 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 876

    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 
876 is amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
 1. The authority citation for part 876 continues to read as follows:

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


0
 Add Sec.  a876.5330 to subpart F to read as follows:


Sec.  876.5330   Transcutaneous electrical continence device.

    (a) Identification. A transcutaneous electrical continence device 
consists of cutaneous electrodes that are used to apply external 
stimulation to reduce urinary incontinence.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must characterize the 
electrical stimulation, including the following: Waveforms, output 
modes, maximum output voltage, maximum output current, pulse duration, 
frequency, net charge per pulse, maximum phase charge at 500 ohms, 
maximum current density, maximum average current, and maximum average 
power density.
    (2) The patient-contacting materials must be demonstrated to be 
biocompatible.
    (3) Performance data must demonstrate the electromagnetic 
compatibility (EMC), electrical safety, thermal safety, and mechanical 
safety of the device.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) Labeling must include the following:
    (i) Instructions for use, including specific instructions regarding 
the proper placement of electrodes;
    (ii) A summary of electrical stimulation parameters; and
    (iii) Cleaning instructions and reuse information.

    Dated: December 16, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
 [FR Doc. 2021-28163 Filed 12-28-21; 8:45 am]
 BILLING CODE 4164-01-P