Rule2025-16040
Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Non-Fusion Spinous Process Spacer Devices
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
August 21, 2025
Effective
August 21, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is classifying orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices 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 classification of orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices. We are taking this action because we have determined that classifying the device into class II 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.
Full Text
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<title>Federal Register, Volume 90 Issue 160 (Thursday, August 21, 2025)</title>
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[Federal Register Volume 90, Number 160 (Thursday, August 21, 2025)]
[Rules and Regulations]
[Pages 40730-40732]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16040]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA-2025-N-2523]
Medical Devices; Orthopedic Devices; Classification of Orthopedic
Manual Surgical Instrumentation for Use With Non-Fusion Spinous Process
Spacer Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
classifying orthopedic manual surgical instrumentation for use with
non-fusion spinous process spacer devices 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
classification of orthopedic manual surgical instrumentation for use
with non-fusion spinous process spacer devices. We are taking this
action because we have determined that classifying the device into
class II 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 August 21, 2025. The classification was
applicable on July 6, 2020.
FOR FURTHER INFORMATION CONTACT: Anne Talley, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G225, Silver Spring, MD 20993-0002, 240-402-6536,
<a href="/cdn-cgi/l/email-protection#f5b49b9b90dba1949999908cb5939194db9d9d86db929a83"><span class="__cf_email__" data-cfemail="82c3ecece7acd6e3eeeee7fbc2e4e6e3aceaeaf1ace5edf4">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified orthopedic manual surgical
instrumentation for use with non-fusion spinous process spacer devices
as class II (special controls), which we have determined will provide a
reasonable
[[Page 40731]]
assurance of safety and effectiveness for its intended use. In
addition, we believe this action will enhance patients' access to
beneficial innovation, in part by reducing regulatory burdens by
placing the device into the appropriate device class based on risk and
the regulatory controls sufficient to provide reasonable assurance of
safety and effectiveness.
FDA may classify a device through an accessory classification
request under section 513(f)(6) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360c(f)(6)), established by section 707 of
the FDA Reauthorization Act of 2017 (Pub. L. 115-52). The provision
allows manufacturers or importers to request classification of an
accessory distinct from another device upon written request. The
classification is based on the risks of the accessory when used as
intended as well as the level of regulatory controls necessary to
provide a reasonable assurance of safety and effectiveness,
notwithstanding the classification of any other device with which such
accessory is intended to be used. Until an accessory is reclassified by
FDA, the classification of any accessory distinct from another device
by regulation or written order issued prior to December 13, 2016, will
continue to apply.
Under section 513(f)(6)(D)(ii) of the FD&C Act, a manufacturer or
importer may request appropriate classification of an accessory that
has been granted marketing authorization as part of a premarket
approval application (PMA), premarket notification (510(k)), or De Novo
classification request. FDA must grant or deny the request not later
than 85 days after receipt and, if granting, publish a notice in the
Federal Register within 30 days of announcing the classification.
Alternatively, under section 513(f)(6)(C) of the FD&C Act, a person
filing a PMA or 510(k) may include a written request for the proper
classification of an accessory that has not been classified distinctly
from another device based on the risks of the accessory when used as
intended and the level of regulatory controls necessary to provide a
reasonable assurance of safety and effectiveness. When the written
request is included in a submission for marketing authorization, FDA
must grant or deny the request along with the response to the PMA or
510(k). Upon granting, FDA will publish a notice in the Federal
Register within 30 days of announcing the classification.
II. Accessory Classification
On April 15, 2020, FDA received RTI Surgical, Inc.'s request for
accessory classification of coflex Interlaminar Technology
Instrumentation. 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 section 513(a)(1)(B) of the FD&C Act). 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 6, 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
888.4520.\1\ We have named the generic type of device ``orthopedic
manual surgical instrumentation for use with non-fusion spinous process
spacer devices,'' and they are identified as non-powered hand-held
devices designed specifically for use with non-fusion spinous process
spacer devices and interface with the associated implant for the
purpose of inserting, positioning, or removing the implant. This type
of device includes instruments specific to the geometry of the implant.
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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.
Table 1--Orthopedic Manual Surgical Instrumentation for Use With Non-
Fusion Spinous Process Spacer Devices Risks and Mitigation Measures
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Identified risks to health Mitigation measures
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Adverse tissue reaction................ Biocompatibility evaluation.
Infection.............................. Reprocessing validation,
Sterilization validation, and
Labeling.
Implant damage or malpositioning....... Validation of technical
specifications, and 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 final order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act (21 U.S.C. 360(k)).
Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) if, after notice of our intent to exempt and consideration of
comments, we determine that premarket notification is not necessary to
provide reasonable assurance of safety and effectiveness of the device.
At a future date, we may publish a separate notice in the Federal
Register announcing our intent to exempt this device.
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.
[[Page 40732]]
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 the guidance document ``Medical
Device Accessories--Describing Accessories and Classification
Pathways'' have been approved under OMB control number 0910-0823; the
collections of information in part 814, subparts A through E, regarding
premarket approval have been approved under OMB control number 0910-
0231; 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 part 807, subpart E,
regarding premarket notification submissions have been approved under
OMB control number 0910-0120; and the collections of information in
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. 888.4520 to subpart E to read as follows:
Sec. 888.4520 Orthopedic manual surgical instrumentation for use with
non-fusion spinous process spacer devices.
(a) Identification. Orthopedic manual surgical instrumentation for
use with non-fusion spinous process spacer devices are non-powered
hand-held devices designed specifically for use with non-fusion spinous
process spacer devices and interface with the associated implant for
the purpose of inserting, positioning, or removing the implant. This
type of device includes instruments specific to the geometry of the
implant.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Technical specifications regarding geometry of the instruments
must be specified and validated to demonstrate that the instruments can
safely position, place, or remove the implant.
(2) The patient contacting components of the device must be
demonstrated to be biocompatible.
(3) Performance data must demonstrate that reprocessing of reusable
devices that are provided non-sterile, or sterilization of devices
provided sterile, is validated.
(4) Labeling must include:
(i) Identification of implant(s) and instruments which have been
validated for use together; and
(ii) Validated methods and instructions for reprocessing any
reusable parts.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16040 Filed 8-20-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on August 21, 2025.
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