Rule2024-19726
Medical Devices; Orthopedic Devices; Classification of the Intervertebral Body Graft Containment Device
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 3, 2024
Effective
September 3, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the intervertebral body graft containment 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 intervertebral body graft containment 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.
Full Text
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<title>Federal Register, Volume 89 Issue 170 (Tuesday, September 3, 2024)</title>
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[Federal Register Volume 89, Number 170 (Tuesday, September 3, 2024)]
[Rules and Regulations]
[Pages 71157-71159]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19726]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA-2024-N-3994]
Medical Devices; Orthopedic Devices; Classification of the
Intervertebral Body Graft Containment Device
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the intervertebral body graft containment 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 intervertebral body graft containment 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 September 3, 2024. The classification
was applicable on September 18, 2020.
FOR FURTHER INFORMATION CONTACT: Aakash Jain, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4566, Silver Spring, MD 20993-0002, 240-402-7531,
<a href="/cdn-cgi/l/email-protection#93d2f2f8f2e0fbbdd9f2fafdd3f5f7f2bdfbfbe0bdf4fce5"><span class="__cf_email__" data-cfemail="7534141e14061d5b3f141c1b351311145b1d1d065b121a03">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the intervertebral body graft
containment device 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.
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 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 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 February 19, 2020, FDA received Spineology, Inc.'s request for
De Novo classification of the Spineology Interbody Fusion System. 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 18, 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
888.3085.\1\ We have named the generic type of device intervertebral
body graft containment device, and it is identified as a non-rigid,
implanted spinal device that is designed to contain bone graft within
its internal cavity. The device is inserted into the intervertebral
body space of the spine and is intended as an adjunct to intervertebral
body fusion.
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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
[[Page 71158]]
this type of device and the measures required to mitigate these risks
in table 1.
Table 1--Intervertebral Body Graft Containment Device Risks and
Mitigation Measures
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Identified risks to health Mitigation measures
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Adverse tissue reaction.................... Design characteristics,
Biocompatibility
evaluation, Sterilization/
reprocessing validation,
and Labeling.
Infection.................................. Sterilization/reprocessing
validation and Labeling.
Loosening/migration due to device failure Design characteristics,
or failure at the bone-implant interface. Clinical performance
testing, Non-clinical
performance testing,
Biocompatibility
evaluation, and Labeling.
Tissue injury.............................. Labeling.
Pseudarthrosis due to device failure or Clinical performance
failure at the bone-implant interface. testing, Non-clinical
performance testing,
Biocompatibility
evaluation, and Labeling.
Adverse clinical sequelae.................. Clinical performance
testing and Labeling.
Use error/Improper device use.............. Labeling.
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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 888
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
888 is amended as follows:
PART 888--ORTHOPEDIC DEVICES
0
1. The authority citation for part 888 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 888.3085 to read as follows:
Sec. 888.3085 Intervertebral body graft containment device.
(a) Identification. An intervertebral body graft containment device
is a non-rigid, implanted spinal device that is designed to contain
bone graft within its internal cavity. The device is inserted into the
intervertebral body space of the spine and is intended as an adjunct to
intervertebral body fusion.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical performance testing must include an assessment of any
adverse events observed during clinical use, as well as intervertebral
body fusion, and compare this to a clinically acceptable fusion rate.
(2) Non-clinical performance testing must demonstrate the
mechanical function and durability of the implant, as well as the
ability of the device to be inserted, deployed, and filled with bone
graft consistently.
(3) Device must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and
sterility of, or the ability to clean and sterilize, the device
components, and device-specific instruments.
(5) Design characteristics of the device, including engineering
schematics, must ensure that the geometry and material composition are
consistent with the intended use.
(6) Labeling must bear all information required for the safe and
effective use of the device, specifically including the following:
(i) A clear description of the technological features of the device
including identification of device materials, compatible components in
the fusion construct, and the principles of device operation;
(ii) Intended use and indications for use, including levels of
fixation;
(iii) Identification of magnetic resonance (MR) compatibility
status;
(iv) Cleaning and sterilization instructions for devices and
instruments that are provided nonsterile to the end user; and
(v) Detailed instructions of each surgical step, including device
removal.
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Dated: August 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19726 Filed 8-30-24; 8:45 am]
BILLING CODE 4164-01-P
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