[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Rules and Regulations]
[Pages 54007-54010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23412]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 874

[Docket No. FDA-2018-N-3772]


Medical Devices; Ear, Nose, and Throat Devices; Classification of 
the Active Implantable Bone Conduction Hearing System

AGENCY: Food and Drug Administration, HHS.

[[Page 54008]]


ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the active implantable bone conduction hearing system 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 active implantable bone conduction hearing system'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, in part by reducing regulatory burdens.

DATES: This order is effective October 26, 2018. The classification was 
applicable on July 20, 2018.

FOR FURTHER INFORMATION CONTACT: Oldooz Hazrati, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2455, Silver Spring, MD 20993-0002, 240-402-9903, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the active implantable bone 
conduction hearing system 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, in part by 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 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 (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 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 (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.
    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 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 February 16, 2017, MED-EL Elektromedizinische Geraete GmbH 
submitted a request for De Novo classification of the BONEBRIDGE. 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 July 20, 2018, FDA issued an order to the requester 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 874.3340. We have named 
the generic type of device active implantable bone conduction hearing 
system, and it is identified as a prescription device consisting of an 
implanted transducer, implanted electronics components, and an audio 
processor. The active implantable bone conduction hearing system is 
intended to compensate for conductive or mixed hearing losses by 
conveying amplified acoustic signals to the cochlea via mechanical 
vibrations on the skull bone.
    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 54009]]



  Table 1--Active Implantable Bone Conduction Hearing System Risks and
                           Mitigation Measures
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            Identified risks                   Mitigation measures
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Dural erosion or compression resulting   Labeling.
 from failure to confirm adequate
 thickness and consistency of bone and
 related anatomy.
Surgical complications leading to:
     Bleeding/hematoma.........
     Seizures..................
     Cerebrospinal fluid (CSF)
     leak.
     Implant damage or           Clinical performance testing
     migration leading to revision/       and Labeling.
     explantation.
Device software failure................  Software verification,
                                          validation, and hazard
                                          analysis.
Implant failure due to:
      Fatigue..................
      Damage/breakage..........
     Loss of hermeticity.......  Clinical performance testing
                                          and Non-clinical performance
                                          testing.
Device failure to compensate for         Clinical performance testing
 hearing loss.                            and Non-clinical performance
                                          testing.
Interference with other devices........  Electromagnetic compatibility
                                          testing, Wireless coexistence
                                          testing, Electrical safety
                                          testing, and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation and
                                          Labeling.
Infection..............................  Sterilization validation, Shelf
                                          life testing, 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. 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.
    At the time of classification, active implantable bone conduction 
hearing systems are for prescription use only. Prescription devices are 
exempt from the requirement for adequate directions for use for the 
layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) 
and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met 
(referring to 21 U.S.C. 352(f)(1)).

III. Analysis of Environmental Impact

    We have 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. 3501-3520). 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 820, regarding quality system regulation, 
have been approved under OMB control number 0910-0073; 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; 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 874

    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 
874 is amended as follows:

PART 874--EAR, NOSE, AND THROAT DEVICES

0
1. The authority citation for part 874 is revised to read as follows:

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

0
2. Add Sec.  874.3340 to subpart D to read as follows:


Sec.  874.3340  Active implantable bone conduction hearing system.

    (a) Identification. An active implantable bone conduction hearing 
system is a prescription device consisting of an implanted transducer, 
implanted electronics components, and an audio processor. The active 
implantable bone conduction hearing system is intended to compensate 
for conductive or mixed hearing losses by conveying amplified acoustic 
signals to the cochlea via mechanical vibrations on the skull bone.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must characterize any adverse 
events observed during implantation and clinical use, and must also 
demonstrate that the device performs as intended under anticipated 
conditions of use.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use, 
including the following:
    (i) Performance data must validate force output in a clinically 
relevant model.
    (ii) Impact testing in a clinically relevant anatomic model must be 
performed.
    (iii) Mechanical integrity testing must be performed.
    (iv) Reliability testing consistent with expected device life must 
be performed.
    (3) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the patient-
contacting components of the device.
    (5) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (6) Performance data must demonstrate the wireless compatibility, 
electromagnetic compatibility, and electrical safety of the device.
    (7) Software verification, validation, and hazard analysis must be 
performed.

[[Page 54010]]

    (8) Labeling must include:
    (i) A summary of clinical testing conducted with the device that 
includes a summary of device-related complications and adverse events;
    (ii) Instructions for use;
    (iii) A surgical guide for implantation, which includes 
instructions for imaging to assess bone dimensions;
    (iv) A shelf life, for device components provided sterile;
    (v) A patient identification card; and
    (vi) A patient user manual.

    Dated: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23412 Filed 10-25-18; 8:45 am]
BILLING CODE 4164-01-P