Notice2025-23901
Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices
Primary source
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Published
December 29, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing that it has received a petition requesting partial exemption from the premarket notification requirements for radiology computer-aided detection and/or diagnosis devices and computer-aided triage and notification devices. Specifically, the petition requests exemption from the premarket notification requirements for the following generic device types when certain conditions described in the petition are met: radiological computer-assisted diagnostic software for lesions suspicious of cancer; medical image analyzers; radiological computer aided triage and notification software; and radiological computer- assisted detection and diagnosis software. FDA is publishing this notice to obtain comments in accordance with procedures established by the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Full Text
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<title>Federal Register, Volume 90 Issue 245 (Monday, December 29, 2025)</title>
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[Federal Register Volume 90, Number 245 (Monday, December 29, 2025)]
[Notices]
[Pages 60730-60732]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23901]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-P-5560]
Medical Devices; Exemption From Premarket Notification: Radiology
Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided
Triage and Notification Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
that it has received a petition requesting partial exemption from the
premarket notification requirements for radiology computer-aided
detection and/or diagnosis devices and computer-aided triage and
notification devices. Specifically, the petition requests exemption
from the premarket notification requirements for the following generic
device types when certain conditions described in the petition are met:
radiological computer-assisted diagnostic software for lesions
suspicious of cancer; medical image analyzers; radiological computer
aided triage and notification software; and radiological computer-
assisted detection and diagnosis software. FDA is publishing this
notice to obtain comments in accordance with procedures established by
the Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES: Submit either electronic or written comments on the notice by
February 27, 2026.
[[Page 60731]]
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 27, 2026. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2025-P-5560 for ``Medical Devices; Exemption from Premarket
Notification: Radiology Computer-Aided Detection and/or Diagnosis
Devices and Computer-Aided Triage and Notification Devices.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Gugandeep Kaur, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5504, Silver Spring, MD 20993-0002, 240-402-9534.
SUPPLEMENTARY INFORMATION:
I. Statutory Background
The FD&C Act, as amended, establishes a comprehensive system for
the regulation of medical devices intended for human use. Section 513
of the FD&C Act (21 U.S.C. 360c) establishes three classes of devices,
reflecting the regulatory controls needed to provide reasonable
assurance of their safety and effectiveness. The three classes of
devices are class I (general controls), class II (special controls),
and class III (premarket approval).
Section 513(a)(1) of the FD&C Act defines the three classes of
devices. Class I devices are those devices for which the general
controls of the FD&C Act (controls authorized by or under section 501,
502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h,
360i, or 360j) or any combination of such sections) are sufficient to
provide reasonable assurance of safety and effectiveness of the device;
or those devices for which insufficient information exists to determine
that general controls are sufficient to provide reasonable assurance of
safety and effectiveness or to establish special controls to provide
such assurance, but because the devices are not purported or
represented to be for a use in supporting or sustaining human life or
for a use which is of substantial importance in preventing impairment
of human health, and do not present a potential unreasonable risk of
illness or injury, are to be regulated by general controls (section
513(a)(1)(A) of the FD&C Act).
Class II devices are those devices for which general controls by
themselves are insufficient to provide reasonable assurance of safety
and effectiveness, but for which there is sufficient information to
establish special controls to provide such assurance, including the
issuance of performance standards, post-market surveillance, patient
registries, development and dissemination of guidelines,
recommendations, and other appropriate actions FDA deems necessary to
provide such assurance (section 513(a)(1)(B) of the FD&C Act).
Class III devices are those devices for which insufficient
information exists to determine that general controls and special
controls would provide a reasonable assurance of safety and
effectiveness, and are purported or represented to be for a use in
supporting or sustaining human life or for a use which is of
substantial importance in preventing impairment of human health, or
present a potential unreasonable risk of illness or injury (section
513(a)(1)(C) of the FD&C Act).
Under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and FDA's
implementing regulations in part 807 (21 CFR part 807), persons who
propose to begin the introduction or delivery for introduction into
interstate commerce for commercial distribution of a device intended
for human use are required to
[[Page 60732]]
submit a premarket notification (510(k)) to FDA. The device may not be
marketed until FDA finds it ``substantially equivalent'' within the
meaning of section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a
legally marketed device that does not require premarket approval.
The 21st Century Cures Act (Pub. L. 114-255) (Cures Act) was signed
into law on December 13, 2016. Section 3054 of the Cures Act amended
section 510(m) of the FD&C Act. As amended, section 510(m)(1) of the
FD&C Act requires that within 90 days of the date of enactment of the
Cures Act, and at least once every 5 years thereafter (as FDA
determines appropriate), FDA publish in the Federal Register a notice
containing a list of each type of class II device that FDA determines
no longer requires a report under section 510(k) of the FD&C Act to
provide reasonable assurance of safety and effectiveness. Additionally,
section 510(m)(2) of the FD&C Act provides that FDA may exempt a class
II device from the requirement to submit a report under section 510(k)
of the FD&C Act, upon its own initiative or a petition of an interested
person, if FDA determines that a report under section 510(k) is not
necessary to assure the safety and effectiveness of the device. FDA
must publish in the Federal Register notice of its intent to exempt the
device, or of the petition, and provide a 60-calendar-day period for
public comment. Within 120 days after the issuance of this notice, FDA
must publish an order in the Federal Register that sets forth its final
determination regarding the exemption of the device that was the
subject of the notice. If FDA fails to respond to a petition under this
section within 180 days of receiving it, the petition shall be deemed
granted.
II. Criteria for Exemption
There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
Federal Register of January 21, 1998 (63 FR 3142) and subsequently in
the guidance the Agency issued on February 19, 1998, entitled
``Procedures for Class II Device Exemptions from Premarket
Notification, Guidance for Industry and CDRH Staff'' (available at
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff</a>).
Accordingly, FDA generally considers the following factors to
determine whether a report under section 510(k) is necessary or if an
exemption would be appropriate for class II devices: (1) the device
does not have a significant history of false or misleading claims or of
risks associated with inherent characteristics of the device; (2)
characteristics of the device necessary for its safe and effective
performance are well established; (3) changes in the device that could
affect safety and effectiveness will either (a) be readily detectable
by users by visual examination or other means such as routine testing,
before causing harm, or (b) not materially increase the risk of injury,
incorrect diagnosis, or ineffective treatment; and (4) any changes to
the device would not be likely to result in a change in the device's
classification. FDA may also consider that, even when exempting devices
from the 510(k) requirements, these devices would still be subject to
the general limitations on exemptions (see 21 CFR 892.9).
III. Proposed Class II Device Exemptions
FDA has received the following petition requesting partial
exemption from the premarket notification requirements for certain
class II devices: Nancy Stade, J.D., of Rubrum Advising, LLC, 404
Pembroke Rd., Bala Cynwyd, PA 19004, on behalf of Harrison.ai, for the
following devices:
<bullet> Radiological computer-assisted diagnostic software for
lesions suspicious of cancer, classified under Sec. 892.2060 (21 CFR
892.2060), product code POK.
<bullet> Medical image analyzer, classified under Sec. 892.2070
(21 CFR 892.2070), product code MYN.
<bullet> Radiological computer aided triage and notification
software, classified under Sec. 892.2080 (21 CFR 892.2080), product
codes QAS and QFM.
<bullet> Radiological computer-assisted detection and diagnosis
software, classified under Sec. 892.2090 (21 CFR 892.2090), product
codes QBS and QDQ.
The petition requests exemption from the premarket notification
requirements for these devices when:
<bullet> The manufacturer has previously obtained a 510(k);
<bullet> For devices under Sec. 892.2080, the manufacturer must
have at least one clearance under the same classification regulation;
<bullet> For devices under Sec. 892.2060, 892.2070, or 892.2090,
the manufacturer must have at least one clearance under any of those
same three classification regulations;
<bullet> The manufacturer must implement a robust post-market plan,
transparency, and training measures as described in the petition; and
<bullet> All existing special controls, quality systems,
establishment registration, and device listing requirements will remain
in force.
FDA seeks comment on the petition in accordance with section
510(m)(2) of the FD&C Act.
IV. Paperwork Reduction Act of 1995
While this notice contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved 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 807, subpart E, regarding premarket notification submissions, have
been approved under OMB control number 0910-0120.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-23901 Filed 12-23-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on December 29, 2025.
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