Medical Devices; Ear, Nose, and Throat Devices; Classification of the Active Implantable Bone Conduction Hearing System, 54007-54010 [2018-23412]
Download as PDF
<![CDATA[
Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Rules and Regulations
54007
TABLE 1—HIGH FLOW HUMIDIFIED OXYGEN DELIVERY DEVICE RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
Adverse tissue reaction ............................................................................
Biocompatibility evaluation, Non-clinical performance testing, and Labeling.
Electromagnetic compatibility testing, Radiofrequency identification testing, and Labeling.
Cleaning validation and Labeling.
Software verification, validation, and hazard analysis; and Labeling.
Non-clinical performance testing and Labeling.
Electrical safety, thermal safety, and mechanical safety testing.
Labeling.
Interference with other devices ................................................................
Infection ....................................................................................................
Device software failure leading to delayed initiation of therapy ..............
Device failure/malfunction leading to ineffective treatment ......................
Electrical shock injury from device failure ................................................
Use error/improper device use leading to hypoxia or worsening
hypercarbia.
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, high flow
humidified oxygen delivery devices 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)).
khammond on DSK30JT082PROD with RULES
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
VerDate Sep<11>2014
18:06 Oct 25, 2018
Jkt 247001
■
(ii) Continuous use thermal stability
testing must be performed;
(iii) Humidity output testing must be
performed; and
(iv) Blender performance testing must
evaluate fraction of inspired oxygen
(FiO2) blending accuracy.
(3) Performance data must validate
cleaning instructions for any reusable
components of the device.
(4) Electrical safety, thermal safety,
mechanical safety, electromagnetic
compatibility, and radiofrequency
identification testing must be
performed.
(5) Software verification, validation,
and hazard analysis must be performed.
(6) Labeling must include:
(i) A description of available FiO2
ranges for different flowrates and inlet
gas pressures;
(ii) Instructions for applicable
flowrates for all intended populations;
(iii) A warning that patients on high
flow oxygen are acute and require
appropriate monitoring, to include
pulse oximetry;
(iv) A warning regarding the risk of
condensation at low set temperatures
and certain flows; and
(v) A description of all alarms and
their functions.
§ 868.5454 High flow humidified oxygen
delivery device.
Dated: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
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 868
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 868 is
amended as follows:
PART 868—ANESTHESIOLOGY
DEVICES
1. The authority citation for part 868
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 868.5454 to subpart F to read
as follows:
(a) Identification. A high flow
humidified oxygen delivery device is a
prescription device that delivers high
flow oxygen with humidification for
patients who are suffering from
respiratory distress and/or hypoxemia.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) The patient-contacting
components of the device must be
demonstrated to be biocompatible.
(2) Non-clinical performance testing
must demonstrate that the device
performs as intended under anticipated
conditions for use, including the
following:
(i) Alarm testing must be performed;
PO 00000
Frm 00043
Fmt 4700
Sfmt 4700
[FR Doc. 2018–23409 Filed 10–25–18; 8:45 am]
BILLING CODE 4164–01–P
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.
E:\FR\FM\26OCR1.SGM
26OCR1
54008
ACTION:
Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Rules and Regulations
Final order.
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,
Oldooz.HazratiYadkoori@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
khammond on DSK30JT082PROD with RULES
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).
VerDate Sep<11>2014
18:06 Oct 25, 2018
Jkt 247001
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
PO 00000
Frm 00044
Fmt 4700
Sfmt 4700
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.
E:\FR\FM\26OCR1.SGM
26OCR1
Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Rules and Regulations
54009
TABLE 1—ACTIVE IMPLANTABLE BONE CONDUCTION HEARING SYSTEM RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
Dural erosion or compression resulting 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 migration leading to revision/explantation ......
Device software failure .............................................................................
Implant failure due to:
• Fatigue.
• Damage/breakage.
• Loss of hermeticity .........................................................................
Device failure to compensate for hearing loss .........................................
Interference with other devices ................................................................
Adverse tissue reaction ............................................................................
Infection ....................................................................................................
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.
khammond on DSK30JT082PROD with RULES
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
VerDate Sep<11>2014
18:06 Oct 25, 2018
Jkt 247001
Labeling.
Clinical performance testing and Labeling.
Software verification, validation, and hazard analysis.
Clinical performance testing and Non-clinical performance testing.
Clinical performance testing and Non-clinical performance testing.
Electromagnetic compatibility testing, Wireless coexistence testing,
Electrical safety testing, and Labeling.
Biocompatibility evaluation and Labeling.
Sterilization validation, Shelf life testing, and Labeling.
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
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.
2. Add § 874.3340 to subpart D to read
as follows:
■
§ 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
PO 00000
Frm 00045
Fmt 4700
Sfmt 4700
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 patientcontacting 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.
E:\FR\FM\26OCR1.SGM
26OCR1
54010
Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Rules and Regulations
(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
LIBRARY OF CONGRESS
U.S. Copyright Office
37 CFR Part 201
I. Background
[Docket No. 2017–10]
Exemption to Prohibition on
Circumvention of Copyright Protection
Systems for Access Control
Technologies
U.S. Copyright Office, Library
of Congress.
ACTION: Final rule.
AGENCY:
In this final rule, the Librarian
of Congress adopts exemptions to the
provision of the Digital Millennium
Copyright Act (‘‘DMCA’’) that prohibits
circumvention of technological
measures that control access to
copyrighted works, codified in the
United States Code. As required under
the statute, the Acting Register of
Copyrights, following a public
proceeding, submitted a
Recommendation concerning proposed
exemptions to the Librarian of Congress.
After careful consideration, the
Librarian adopts final regulations based
upon the Acting Register’s
Recommendation.
SUMMARY:
DATE:
Effective October 28, 2018.
khammond on DSK30JT082PROD with RULES
FOR FURTHER INFORMATION CONTACT:
Regan A. Smith, General Counsel and
Associate Register of Copyrights, by
email at regans@copyright.gov, Anna
Chauvet, Assistant General Counsel, by
email at achau@copyright.gov, or Kevin
Amer, Senior Counsel for Policy and
International Affairs, by email at
kamer@copyright.gov. Each can be
contacted by telephone by calling (202)
707–8350.
SUPPLEMENTARY INFORMATION: The
Librarian of Congress, pursuant to
VerDate Sep<11>2014
18:06 Oct 25, 2018
section 1201(a)(1) of title 17, United
States Code, has determined in this
seventh triennial rulemaking proceeding
that the prohibition against
circumvention of technological
measures that effectively control access
to copyrighted works shall not apply to
persons who engage in noninfringing
uses of certain classes of such works.
This determination is based upon the
Recommendation of the Acting Register
of Copyrights, which was transmitted to
the Librarian on October 5, 2018.1
The below discussion summarizes the
rulemaking proceeding and Register’s
Recommendation, announces the
Librarian’s determination, and
publishes the regulatory text specifying
the exempted classes of works. A more
complete discussion of the rulemaking
process, the evidentiary record, and the
Acting Register’s analysis can be found
in the Acting Register’s
Recommendation, which is posted at
www.copyright.gov/1201/2018/.
Jkt 247001
A. Statutory Requirements
Congress enacted the DMCA in 1998
to implement certain provisions of the
WIPO Copyright and WIPO
Performances and Phonograms Treaties.
Among other things, title I of the DMCA,
which added a new chapter 12 to title
17 of the U.S. Code, prohibits
circumvention of technological
measures employed by or on behalf of
copyright owners to protect access to
their works. In enacting this aspect of
the law, Congress observed that
technological protection measures
(‘‘TPMs’’) can ‘‘support new ways of
disseminating copyrighted materials to
users, and . . . safeguard the
availability of legitimate uses of those
materials by individuals.’’ 2
Section 1201(a)(1) provides in
pertinent part that ‘‘[n]o person shall
circumvent a technological measure that
effectively controls access to a work
protected under [title 17].’’ Under the
statute, to ‘‘circumvent a technological
measure’’ means ‘‘to descramble a
scrambled work, to decrypt an
encrypted work, or otherwise to avoid,
bypass, remove, deactivate, or impair a
technological measure, without the
authority of the copyright owner.’’ 3 A
1 Acting Register of Copyrights, Section 1201
Rulemaking: Seventh Triennial Proceeding to
Determine Exemptions to the Prohibition on
Circumvention, Recommendation of the Acting
Register of Copyrights (Oct. 2018) (‘‘Acting
Register’s Recommendation’’).
2 Staff of H. Comm. on the Judiciary, 105th Cong.,
Section-by-Section Analysis of H.R. 2281 as Passed
by the United States House of Representatives on
August 4, 1998, at 7 (Comm. Print 1998).
3 17 U.S.C. 1201(a)(3)(A).
PO 00000
Frm 00046
Fmt 4700
Sfmt 4700
technological measure that ‘‘effectively
controls access to a work’’ is one that
‘‘in the ordinary course of its operation,
requires the application of information,
or a process or a treatment, with the
authority of the copyright owner, to gain
access to the work.’’ 4
Section 1201(a)(1) also includes what
Congress characterized as a ‘‘fail-safe’’
mechanism,5 which requires the
Librarian of Congress, following a
rulemaking proceeding, to publish any
class of copyrighted works as to which
the Librarian has determined that
noninfringing uses by persons who are
users of a copyrighted work are, or are
likely to be, adversely affected by the
prohibition against circumvention in the
succeeding three-year period, thereby
exempting that class from the
prohibition for that period.6 The
Librarian’s determination to grant an
exemption is based upon the
recommendation of the Register of
Copyrights, who conducts the
rulemaking proceeding.7 The Register,
in turn, consults with the Assistant
Secretary for Communications and
Information of the Department of
Commerce, who oversees the National
Telecommunications and Information
Administration (‘‘NTIA’’), in the course
of formulating her recommendation.8
The primary responsibility of the
Register and the Librarian in the
rulemaking proceeding is to assess
whether the implementation of access
controls impairs the ability of
individuals to make noninfringing uses
of copyrighted works within the
meaning of section 1201(a)(1). To do
this, the Register develops a
comprehensive administrative record
using information submitted by
interested members of the public, and
makes recommendations to the
Librarian concerning whether
exemptions are warranted based on that
record.
Under the statutory framework, the
Librarian, and thus the Register, must
consider ‘‘(i) the availability for use of
copyrighted works; (ii) the availability
for use of works for nonprofit archival,
preservation, and educational purposes;
(iii) the impact that the prohibition on
the circumvention of technological
measures applied to copyrighted works
has on criticism, comment, news
reporting, teaching, scholarship, or
research; (iv) the effect of circumvention
of technological measures on the market
4 Id.
at 1201(a)(3)(B).
H.R. Rep. No. 105–551, pt. 2, at 36 (1998)
(‘‘Commerce Comm. Report’’).
6 See 17 U.S.C. 1201(a)(1).
7 Id. at 1201(a)(1)(C).
8 Id.
5 See
E:\FR\FM\26OCR1.SGM
26OCR1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
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
