[Federal Register Volume 91, Number 179 (Thursday, September 17, 2026)]
[Rules and Regulations]
[Pages 58817-58819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-19074]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 892
[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: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing an order
setting forth its final determination regarding a partial exemption
from the premarket notification requirements for radiology computer-
aided detection and/or diagnosis devices and computer-aided triage and
notification devices that was the subject of a notice published in the
Federal Register of December 29, 2025. That notice announced FDA's
receipt of a petition that requested exemption from the premarket
notification requirements for the following generic device types when
certain conditions described in the petition were 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 denied the petition in a response issued to the
petitioner on April 1, 2026. FDA is publishing this order in accordance
with procedures established by the Federal Food, Drug, and Cosmetic Act
(FD&C Act).
DATES: This order is effective September 17, 2026.
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. Background--Regulatory Authorities
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 (the Agency or we)
deems necessary to provide such assurance (section 513(a)(1)(B) of the
FD&C Act).
[[Page 58818]]
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 and FDA's implementing
regulations in part 807, subpart E (21 CFR part 807, subpart E),
persons who are required to register and 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 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 to a legally marketed device
that does not require premarket approval. A premarket notification is
not required for devices in certain situations, such as when they have
been exempted from that requirement under section 510(m) of the FD&C
Act.
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. After
providing at least a 60-day public comment period, FDA must then
publish in the Federal Register a list representing the final
determination with respect to the devices contained in the list under
section 510(m)(1)(B). 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 a notice of its intent to exempt the device, or of the
petition, and provide a 60-calendar-day period for public comment. If
FDA fails to respond to a petition under this section within 180 days
of receiving it, the petition shall be deemed granted. In addition,
within 120 days after the issuance of the 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.
II. Factors FDA Generally Considers for Exemption
There are several factors FDA may consider to determine whether a
510(k) is not necessary to assure 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'' (Class II 510(k) Exemption Guidance) (available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff).
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 general
limitations of exemptions. Specifically, even if a device is exempted
from premarket notification requirements, a manufacturer of the device
will still be required to submit a premarket notification to FDA before
introducing a device or delivering it for introduction into interstate
commerce for commercial distribution when the device exceeds any of the
limitations of exemptions described in 21 CFR parts 862-892, in the
section of each part entitled ``Limitations of exemptions from section
510(k) of the Federal Food, Drug, and Cosmetic Act (the act)'' (see,
e.g., 21 CFR 892.9).
In addition to the general limitations, partial limitations may
limit an exemption from premarket notification requirements to specific
devices within a device type when the Agency determines that the
factors described in the Federal Register notice (63 FR 3142) and Class
II 510(k) Exemption Guidance do not weigh in favor of exemption for all
devices within a generic type of device. Where partial limitations
exist, FDA has determined that premarket notification is necessary to
provide a reasonable assurance of safety and effectiveness for devices
that fall outside of the limitations.
III. Petition
On October 22, 2025, FDA received a petition requesting partial
exemption from 510(k) requirements for ``radiology Computer-Aided
Detection and/or Diagnosis (CAD) and Computer-Aided Triage and
Notification (CADt) devices'' (the Subject CAD and CADt Devices) from
Nancy Stade, J.D., of Rubrum Advising, LLC, 404 Pembroke Rd., Bala
Cynwyd, PA 19004, on behalf of Harrison.ai (see Docket No. FDA-2025-P-
5560). Specifically, the petition sought partial exemption for the
following devices:
Radiological computer-assisted diagnostic software for
lesions suspicious of cancer, classified under Sec. 892.2060 (21 CFR
892.2060), product code POK (CADx).
Medical image analyzer, classified under Sec. 892.2070
(21 CFR 892.2070), product code MYN (CADe).
Radiological computer aided triage and notification
software, classified under Sec. 892.2080 (21 CFR 892.2080), product
codes QAS and QFM (CADt).
Radiological computer-assisted detection and diagnosis
software, classified under Sec. 892.2090 (21 CFR 892.2090), product
codes QBS and QDQ (CADe/x).
All these devices currently require premarket notification under
section 510(k) of the FD&C Act.
The petition requested exemption from the premarket notification
requirements for the Subject CAD and CADt Devices when:
The manufacturer had previously obtained a 510(k);
For devices under Sec. 892.2080 (the Subject CADt
Devices), the manufacturer had at least one clearance under the same
classification regulation;
For devices under Sec. Sec. 892.2060, 892.2070, or
892.2090 (the Subject CAD Devices), the manufacturer had at least
[[Page 58819]]
one clearance under any of those same three classification regulations;
The manufacturer implemented ``a robust post-market plan,
transparency, and training measures'' as described in the petition; and
All existing ``special controls, quality systems,
establishment registration, and device listing requirements'' remained
in force.
On December 29, 2025, FDA published a notice of the petition in the
Federal Register (90 FR 60730) and requested comments on it, in
accordance with section 510(m)(2) of the FD&C Act. The comment period
closed on February 27, 2026.
FDA considered the information available to the Agency, including
comments from the public docket for the petition and Federal Register
notice, and determined not to exempt devices classified under
Sec. Sec. 892.2060, 892.2070, 892.2080, and 892.2090 from the 510(k)
requirements subject to the partial limitations of exemption proposed
in the petition.\1\ Accordingly, FDA responded to the petition by
letter dated April 1, 2026, denying the petition within the 180-day
timeframe under section 510(m)(2) of the FD&C Act.
---------------------------------------------------------------------------
\1\ In considering the petition and comments submitted to the
docket, FDA has assumed that all elements of petitioner's proposal
were partial limitations on exemption that FDA may consider under
section 510(m)(2) of the FD&C Act and we refer to them as partial
limitations on exemption throughout this order.
---------------------------------------------------------------------------
IV. Order
As discussed in the petition response issued to the petitioner on
April 1, 2026, based on FDA's review of the petition's proposed partial
exemption, and in consideration of the comments submitted to the docket
and FDA's own assessment of each of the four factors for exemption
described in the Federal Register notice (63 FR 3142) and the Class II
510(k) Exemption Guidance, FDA determined that the information
presented in the petition does not demonstrate that premarket
notification is not necessary to assure the safety and effectiveness of
the Subject CAD and CADt Devices that may be covered by the petition's
proposed partial exemption. Therefore, FDA denied the petition request
for partial exemption from premarket notification requirements for the
Subject CAD and CADt Devices and is issuing this order setting forth
the final determination. FDA's response to the petition can be found in
Docket No. FDA-2025-P-5560, available at https://www.regulations.gov/docket/FDA-2025-P-5560.
Manufacturers of the Subject CAD and CADt Devices must continue to
submit and receive FDA clearance of a 510(k) submission before
marketing their devices, as well as comply with all other applicable
requirements under the FD&C Act.
Although FDA determined that the proposal in the petition did not
support a partial exemption from 510(k) requirements under section
510(m)(2) of the FD&C Act, the Agency has a longstanding commitment to
develop and apply innovative approaches to the regulation of medical
device software and other digital health devices to ensure their safety
and effectiveness consistent with least burdensome principles. FDA
supports the continued consideration of innovative and least burdensome
approaches that may accelerate the availability of safe and effective
devices.
V. Analysis of Environmental Impact
We have determined under 21 CFR 25.34(b) that this action is of a
type that does not normally have a significant effect on the human
environment. Therefore, neither an environmental assessment nor an
environmental impact statement is required.
VI. Paperwork Reduction Act of 1995
This final administrative order refers to previously approved
collections of information found in FDA regulations. 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 21 CFR
part 820 (Quality Management System Regulation) have been approved
under OMB control number 0910-0073; the collections of information in
21 CFR part 812 (Investigational Device Exemptions) have been approved
under OMB control number 0910-0078; the collections of information in
part 807, subpart E (Premarket Notification Procedures), have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 822 (Postmarket Surveillance) have been
approved under OMB control number 0910-0449; and the collections of
information under 21 CFR part 801 (Device Labeling) have been approved
under OMB control number 0910-0485.
VII. References
The following reference is on display at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500, and is available for viewing
by interested persons between 9 a.m. and 4 p.m., Monday through Friday;
it is also available electronically at https://www.regulations.gov.
Although FDA verified the website addresses in this document, please
note that websites are subject to change over time.
1. FDA Guidance, ``Procedures for Class II Device Exemptions from
Premarket Notification, Guidance for Industry and CDRH Staff,''
February 19, 1998, available at https://www.fda.gov/media/72685/download.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-19074 Filed 9-16-26; 8:45 am]
BILLING CODE 4164-01-P