Rule2025-21218
Medical Devices; Neurological Devices; Classification of Field Generator Positioning 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
November 26, 2025
Effective
November 26, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is classifying the field generator positioning device into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general 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.
Full Text
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<title>Federal Register, Volume 90 Issue 226 (Wednesday, November 26, 2025)</title>
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[Federal Register Volume 90, Number 226 (Wednesday, November 26, 2025)]
[Rules and Regulations]
[Pages 54232-54234]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-21218]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA-2025-N-4680]
Medical Devices; Neurological Devices; Classification of Field
Generator Positioning Device
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 the field generator positioning device into class I
(general controls). We are taking this action because we have
determined that classifying the device into class I (general 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 November 26, 2025. The classification
was applicable on July 10, 2020.
FOR FURTHER INFORMATION CONTACT: Payton Lin, Center for Devices and
[[Page 54233]]
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1212, Silver Spring, MD 20993-0002, 240-402-6580,
<a href="/cdn-cgi/l/email-protection#cd9dacb4b9a2a3e381a4a38daba9ace3a5a5bee3aaa2bb"><span class="__cf_email__" data-cfemail="cd9dacb4b9a2a3e381a4a38daba9ace3a5a5bee3aaa2bb">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the field generator positioning
device as class I (general controls), which we have determined will
provide a reasonable 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), 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 17, 2020, FDA received Stryker ENT's request for accessory
classification of the TGS Universal Headrest with Mounting Arm. 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 I if general controls are sufficient
to provide reasonable assurance of safety and effectiveness of the
device for its intended use (see section 513(a)(1)(A) of the FD&C Act).
After review of the information submitted in the request, we determined
that the device can be classified into class I (general controls). FDA
has determined that general controls will provide reasonable assurance
of the safety and effectiveness of the device.
Therefore, on July 10, 2020, FDA issued an order to the requester
classifying the device into class I. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
882.4565.\1\ We have named the generic type of device ``field generator
positioning device,'' and it is identified as a manual, mechanical
device intended to position the field generator of an electromagnetic
based stereotaxic navigation system in proximity to a patient. The
device may operate independently or adapt existing medical equipment,
such as a procedure chair or surgical bed, by using a mechanical
interface.
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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: mechanical failure (which could
damage the field generator or cause the device to physically impact the
patient), interference from items within the projected field, or
movement of the electromagnetic field projection.
Section 510(l)(1) of the FD&C Act provides that a device within a
type that has been classified into class I under section 513 of the
FD&C Act is exempt from premarket notification under section 510(k),
unless the device is of substantial importance in preventing impairment
of human health or presents a potentially unreasonable risk of illness
or injury (21 U.S.C. 360(l)(1)). Devices within this type are exempt
from the premarket notification requirements under section 510(k),
subject to the limitations of exemptions in 21 CFR 882.9.
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 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 882
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
882 is amended as follows:
[[Page 54234]]
PART 882--NEUROLOGICAL DEVICES
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1. The authority citation for part 882 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
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2. Add Sec. 882.4565 to subpart E to read as follows:
Sec. 882.4565 Field generator positioning device.
(a) Identification. A field generator positioning device is a
manual, mechanical device intended to position the field generator of
an electromagnetic based stereotaxic navigation system in proximity to
a patient. The device may operate independently or adapt existing
medical equipment, such as a procedure chair or surgical bed, by using
a mechanical interface.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 882.9.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-21218 Filed 11-25-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on November 26, 2025.
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