Rule2023-00008
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Powered Insertion System for a Cochlear Implant Electrode Array
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
January 6, 2023
Effective
January 6, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the powered insertion system for a cochlear implant electrode array 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 powered insertion system for a cochlear implant electrode array'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
<html>
<head>
<title>Federal Register, Volume 88 Issue 4 (Friday, January 6, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 4 (Friday, January 6, 2023)]
[Rules and Regulations]
[Pages 977-979]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-00008]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 874
[Docket No. FDA-2022-N-3171]
Medical Devices; Ear, Nose, and Throat Devices; Classification of
the Powered Insertion System for a Cochlear Implant Electrode Array
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Final amendment; final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the powered insertion system for a cochlear implant
electrode array 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 powered insertion system for a
cochlear implant electrode array'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 January 6, 2023. The classification was
applicable on October 1, 2021.
FOR FURTHER INFORMATION CONTACT: Vasant Dasika, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1206, Silver Spring, MD, 20993-0002, 301-796-5365,
<a href="/cdn-cgi/l/email-protection#71271002101f055f351002181a10311715105f1919025f161e07"><span class="__cf_email__" data-cfemail="60360113010e144e240113090b01200604014e0808134e070f16">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the powered insertion system for a
cochlear implant electrode array 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 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 (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
less-burdensome 510(k) process, when necessary, to market their device.
II. De Novo Classification
On December 18, 2019, FDA received iotaMotion, Inc.'s request for
De Novo classification of the iotaSOFT Insertion System--Drive Unit,
Controller and Accessories. 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
[[Page 978]]
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 October 1, 2021, 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
874.4450.\1\ We have named the generic type of device powered insertion
system for a cochlear implant electrode array, and it is identified as
a prescription device used to assist in placing an electrode array into
the cochlea.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
Table 1--Powered Insertion System for a Cochlear Implant Electrode Risks
and Mitigation Measures
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Risks to health relating to device Clinical performance testing,
interface with patient anatomy, Usability testing, Non-
including: clinical performance testing,
<bullet> Damage to skull tissue. and Labeling.
<bullet> Damage to dura mater.
<bullet> Bone damage.
<bullet> Cerebrospinal fluid leak.
<bullet> Damage to cochlea; hearing
loss, tinnitus, vertigo.
Cochlear implant insertion failure Clinical performance testing,
leading to:. Non-clinical performance
<bullet> Trauma to cochlear structures testing, Usability testing,
resulting in residual hearing loss or Cochlear implant compatibility
nerve degeneration.. validation, Software
<bullet> Suboptimal array placement verification, validation, and
(including array rotation) leading to hazard analysis, and Labeling.
poor hearing performance..
<bullet> Failure to disengage from
cochlear implant at end of procedure,
leading to manual correction and
insertion..
Damage to cochlear implant during Non-clinical performance
insertion leading to poor cochlear testing, Usability testing,
implant performance and/or compromised Cochlear implant compatibility
implant reliability. validation, Shelf life
testing, Software
verification, validation, and
hazard analysis, and Labeling.
Adverse tissue reaction, including Biocompatibility evaluation.
irritation/inflammation of surgical
site.
Electromagnetic interference, thermal Electrical safety testing,
injury, or electric shock. Electromagnetic compatibility
testing, and Labeling.
Infection.............................. Sterilization validation, Shelf
life testing, and Labeling.
Excessive operation time leading to Clinical performance testing,
increased exposure to anesthesia. Usability 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, powered insertion systems for a
cochlear implant electrode array 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.
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 21 CFR 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 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:
[[Page 979]]
PART 874--EAR, NOSE, AND THROAT DEVICES
0
1. The authority citation for part 874 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 874.4450 to subpart E to read as follows:
Sec. 874.4450 Powered insertion system for a cochlear implant
electrode array.
(a) Identification. A powered insertion system for a cochlear
implant electrode array is a prescription device used to assist in
placing an electrode array into the cochlea.
(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, including
evaluation of all adverse events.
(2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use.
Testing must include:
(i) Verification of cochlear implant attachment force, release
force, and insertion speed;
(ii) Testing to demonstrate the device does not damage or degrade
the cochlear implant (including the lead and array portions of the
cochlear implant); and
(iii) Comparison testing with manual insertion to evaluate:
(A) Differences in cochlear implant array insertion force
associated with use of the device; and
(B) Intracochlear placement of the cochlear implant array (intended
scala placement and array insertion depth, together with minimal array
tip foldover and cochlear scala translocation).
(3) Usability testing in a simulated hospital environment with an
anatomically relevant model (e.g., cadaver testing) that evaluates the
following:
(i) Successful use to aid in placement of the electrode array into
the cochlea; and
(ii) Harms caused by use errors observed.
(4) Changes in cochlear implant compatibility are determined to
significantly affect the safety or effectiveness of the device and must
be validated through performance testing or a rationale for omission of
any testing.
(5) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(6) Performance testing must demonstrate the electromagnetic
compatibility, electrical safety, and thermal safety of the device.
(7) The patient-contacting components of the device must be
demonstrated to be sterile and non-pyrogenic.
(8) Performance testing must support the shelf life of device
components provided sterile by demonstrating continued sterility,
package integrity, and device functionality over the labeled shelf
life.
(9) Software verification, validation, and hazard analysis must be
performed for any software components of the device.
(10) Labeling must include:
(i) The recommended training for the safe use of the device;
(ii) Summary of the relevant clinical and non-clinical testing
pertinent to use of the device with compatible electrode arrays; and
(iii) A shelf life.
Dated: January 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00008 Filed 1-5-23; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on January 6, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.