Notice2026-02377
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
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
February 6, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) has identified a list of class II devices that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice and requesting public comment in accordance with procedures established by the 21st Century Cures Act. This notice does not represent FDA's final determination with respect to the devices included in this document. FDA will review any comments submitted within the 60-day comment period and will consider whether the list of class II devices should be modified prior to publication of its final determination in the Federal Register.
Full Text
<html>
<head>
<title>Federal Register, Volume 91 Issue 25 (Friday, February 6, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 25 (Friday, February 6, 2026)]
[Notices]
[Pages 5485-5489]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-02377]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0232]
Medical Devices; Exemptions From Premarket Notification: Class II
Devices; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has identified a list
of class II devices that, when finalized, will be exempt from premarket
notification requirements, subject to certain limitations. FDA is
publishing this notice and requesting public comment in accordance with
procedures established by the 21st Century Cures Act. This notice does
not represent FDA's final determination with respect to the devices
included in this document. FDA will review any comments submitted
within the 60-day comment period and will consider whether the list of
class II devices should be modified prior to publication of its final
determination in the Federal Register.
DATES: Submit either electronic or written comments on the notice by
April 7, 2026.
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 April 7, 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
[[Page 5486]]
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-2026-N-0232 for ``Medical Devices; Exemptions from Premarket
Notification: Class II Devices; Request for Comments.'' 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.gpo.gov/fdsys/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: Jismi Johnson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1528, Silver Spring, MD 20993, 301-796-6424,
<a href="/cdn-cgi/l/email-protection#400a29332d296e0a2f282e332f2e002624216e2828336e272f36"><span class="__cf_email__" data-cfemail="4d07243e202463072225233e22230d2b292c6325253e632a223b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Food, Drug, and Cosmetic Act (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).
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 of Title 21 of the Code of Federal Regulations
(CFR), subpart E, 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 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 (Cures Act) (Pub. L. 114-255) 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)(A) 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
[[Page 5487]]
requires a report under section 510(k) of the FD&C Act to provide
reasonable assurance of safety and effectiveness. Additionally, FDA
must provide at least a 60-day comment period for any such notice
published under section 510(m)(1)(A) of the FD&C Act. FDA published its
initial notice under section 510(m)(1)(A) of the FD&C Act in the
Federal Register of March 14, 2017 (82 FR 13609), and issued its final
determination of exemption of the devices in such notice in accordance
with section 510(m)(1)(B) of the FD&C Act in the Federal Register of
July 11, 2017 (82 FR 31976).
FDA is now publishing this notice and requesting public comment in
accordance with section 510(m)(1)(A) of the FD&C Act. In a future
action, and after considering comments, FDA intends to amend the
codified language for each listed regulation to reflect FDA's final
determination with respect to each exempt class II device type. Such
final action will decrease regulatory burdens on the medical device
industry and will eliminate private costs and expenditures required to
comply with Federal regulation. Specifically, regulated industry will
no longer have to invest time and resources in 510(k) submissions for
devices exempt from such requirements.
II. Factors FDA May Consider 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
January 21, 1998, Federal Register notice (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'') (Ref. 1). Accordingly, FDA generally considers
the following factors to determine whether premarket notification 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 limitations of exemptions. FDA's determination
that premarket notification is not necessary to provide a reasonable
assurance of safety and effectiveness for class II devices is based, in
part, on the Agency's knowledge of the devices, including past
experience and relevant reports or studies on device performance (as
appropriate), the applicability of general and special controls, and
the Agency's ability to limit an exemption, as discussed in section III
of this notice.
III. Limitations of Exemptions
A. General Limitations of Exemptions
FDA's proposal to exempt the class II devices listed in table 1 and
table 2 from premarket notification requirements applies only to those
devices that have existing or reasonably foreseeable characteristics of
commercially distributed devices within that generic type. After the
60-day comment period and FDA's issuance of a notice announcing FDA's
final determination, a manufacturer of a device listed in this document
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 meets 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).'' \1\
---------------------------------------------------------------------------
\1\ See 21 CFR 862.9, 864.9, 866.9, 868.9. 870.9, 872.9, 874.9,
876.9, 878.9, 880.9, 882.9, 884.9, 886.9, 888.9, 890.9, and 892.9.
---------------------------------------------------------------------------
B. Partial Limitations of Exemptions
In addition to the general limitations described in section III.A
of this notice, partial limitations may limit an exemption from
premarket notification requirements to devices that satisfy certain
conditions within a device type when the Agency determines that the
factors described in the Class II 510(k) Exemption Guidance (Ref. 1) do
not weigh in favor of exemption for all devices within a generic type
of device. Where a partial limitation of exemption has been identified
in this notice (see table 2), 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.
In table 2, for example, FDA is listing a proposed exemption from
510(k) requirements for uterine tenaculum (21 CFR 884.4530, product
code HDC \2\) but is limiting the proposed exemption to manual
mechanical devices. The proposed exemption thus excludes devices that
are powered. Whereas the characteristics of a manual mechanical uterine
tenaculum necessary for the safe and effective performance of the
device are well-established, a powered uterine tenaculum has a
relatively complex design that carries additional risks beyond those of
a manual mechanical device, and FDA therefore considers premarket
notification requirements for a powered device, such as a vacuum-based
device, to be necessary to provide a reasonable assurance of safety and
effectiveness. If this proposed exemption is finalized, a uterine
tenaculum that meets the partial limitation of exemptions and the
general limitations of exemptions in 21 CFR 884.9 would be exempt from
the 510(k) requirements and would be identified under a new product
code. However, a uterine tenaculum that does not meet the limitations
of exemptions would remain subject to 510(k) requirements and would
remain under the product code HDC.
---------------------------------------------------------------------------
\2\ FDA's Center for Devices and Radiological Health (CDRH) uses
product codes to help categorize and ensure consistent regulation of
medical devices. A product code consists of three characters that
are assigned at the time a product code is generated and is unique
to a product type. The three characters carry no other significance
and are not an abbreviation.
---------------------------------------------------------------------------
IV. List of Class II Devices
FDA has determined that premarket notification is not necessary to
provide a reasonable assurance of safety and effectiveness for the
class II devices listed in table 1 and table 2 of this notice.
In table 1, FDA is identifying the following list of class II
devices that, if finalized, would no longer require premarket
notification under section 510(k) of the FD&C Act, subject to the
general limitations of exemptions described in section III.A of this
notice:
[[Page 5488]]
Table 1--Proposed Exempt Class II Devices Subject to General Limitations
------------------------------------------------------------------------
21 CFR section Device type Product code
------------------------------------------------------------------------
870.1120.................... Blood pressure cuff...... DXQ
872.3920.................... Teeth, porcelain......... ELL
872.6660.................... Powder, porcelain........ EIH
876.1500.................... Image, illumination, FFS
fiberoptic, for
endoscope.
876.1500.................... Jelly, lubricating, for FHX
transurethral surgical
instrument.
876.4300.................... System, alarm, FFI
electrosurgical.
876.5360.................... Laparoscopic accessories, QJN
esophageal sizing.
878.4370.................... Dental barriers and PEM
sleeves.
884.4530.................... Forceps, surgical, HCZ
gynecological.
886.1640.................... Preamplifier, AC-powered, HLT
ophthalmic.
886.1640.................... Preamplifier, battery- HLW
powered, ophthalmic.
888.4515.................... Manual instruments QLQ
designed for use with
total disc replacement
devices.
888.4520.................... Manual instruments QLR
designed for use with
non-fusion spinous
process spacer devices.
------------------------------------------------------------------------
In table 2, FDA is identifying the following list of class II
devices that, if finalized, would no longer require premarket
notification under section 510(k) of the FD&C Act, subject to the
proposed partial limitations of exemptions as well as the general
limitations of exemptions found in Sec. Sec. 862.9 to 892.9. If this
list is finalized, devices listed in table 2 would be exempt only if
they meet the proposed partial limitations of exemptions specified in
table 2 and the corresponding general limitations of exemptions
described in section III.A of this notice.
Table 2--Proposed Exempt Class II Devices Subject to General Limitations and Partial Limitations
----------------------------------------------------------------------------------------------------------------
21 CFR section Device type Product code Partial limitations
----------------------------------------------------------------------------------------------------------------
870.1875...................... Stethoscope, DQD Exemption is limited to devices that
electronic. meet the following conditions:
1. Stethoscopes without algorithms;
2. Stethoscopes without diagnostic
outputs, such as murmur detection,
arrhythmias, or heart failure; and
3. Stethoscopes solely intended for
sound amplification, filtering, and
transferring sounds.
870.5800...................... Sleeve, limb, JOW Exemption is limited to devices that
compressible. meet the following conditions:
1. Device is intended for
prescription use in adults with
intact skin;
2. Device is indicated only for deep
vein thrombosis (DVT) prophylaxis
and for the treatment of lymphedema,
venous stasis ulcers, venous
insufficiency, and/or peripheral
edema;
3. Device is a garment only and
intended for single patient use on
thigh, calf, ankle and/or foot;
4. Device is pneumatic with operating
pressures between 20mmHg and 120mmHG
and inflation time between 5s to 30s
and deflation time between 30s to
120s; and
5. Device is not intended to heat or
cool a patient.
878.4810...................... Light based over the OHS Exemption is limited to devices that
counter wrinkle meet the following conditions:
reduction.
1. Device emitters have a maximum
output that cannot produce
intensities at the skin surface that
exceed 150 mW/cm\2\ and 180 J/cm\2\
per treatment; and
2. Device uses only yellow, red, or
amber, or a combination of yellow,
red, or amber with infrared color
(from 800nm to 900nm) of light.
878.4810...................... Light based over-the- OHT Exemption is limited to devices that
counter hair removal. meet the following conditions:
1. Device emitters have a pulse width
>=0.5 milliseconds, spot size <=7
cm\2\, and fluence <=10 J/cm\2\;
2. Device uses Intense Pulsed Light
(IPL) with a wavelength range of
470nm-1200nm; and
3. Device is intended for use on the
legs, arms, back, chest, upper lip,
and/or armpit.
880.5570...................... Container, sharps..... MMK Exemption is limited to devices that
meet the following conditions:
1. Device is intended for single use;
2. Device is intended to be used in a
healthcare setting;
3. Device is intended to contain only
sharps for disposal;
4. Device does not include software
or electronic components; and
5. Appropriate analysis and non-
clinical testing (such as that
outlined in the currently FDA-
recognized editions of ISO 23908,
``Sharps injury protection--
Requirements and test methods--
Sharps protection features for
single-use hypodermic needles,
introducers for catheters and
needles used for blood sampling,''
and ISO 23907-1, ``Sharps injury
protection--Requirements and test
methods--Part 1: Single-use sharps
containers'') must validate
specifications and performance of
the device.
[[Page 5489]]
884.4530...................... Tenaculum, uterine.... HDC Exemption is limited to manual
mechanical devices.
884.5160...................... Pump, breast, powered. HGX Exemption is limited to devices that
meet the following conditions:
1. Device is a tabletop breast pump
that has a vacuum pressure <250
mmHg, uses AC/DC power only, and
does not include a battery; and
2. Device does not utilize internet,
wireless connection, communication
ports (e.g., USB) capable of
updating software or transmitting
information, or a mobile
application.
884.5300...................... Lubricant, personal... NUC Exemption is limited to devices that
meet the following conditions:
1. Device is made entirely of
silicone (i.e., dimethicone,
dimethiconol, cyclopentasiloxane)
with no additional ingredients;
2. Water activity is <0.3 Aw per
USP<1112> (Application of Water
Activity Determination to Nonsterile
Pharmaceutical Products); and
3. Device is not intended for
treatment of medical conditions or
specific patient populations.
884.6170...................... System, water, MTW Exemption is limited to assisted
reproduction, reproduction water and does not
assisted, and include water purification systems.
purification.
890.5500...................... Laser, comb, hair..... OAP Exemption is limited to devices that
meet the following conditions:
1. Device emitters have a maximum
output that cannot produce
intensities at the scalp surface
that exceed 68 J/cm\2\; and
2. Device only uses red light.
890.5650...................... Massager, powered IRP Exemption is limited to devices that
inflatable tube. meet the following conditions:
1. Device is pneumatic with operating
pressures between 0 mmHg and 200
mmHg positive pressures;
2. Device is indicated for adults in
good health, for the temporary
relief of minor muscle aches and/or
pains, for temporary increase in
circulation to the treated areas,
and/or to simulate kneading and
stroking of tissues;
3. Device is not intended for use on
neck and/or head;
4. If device compresses thoracic
(chest, back) and/or abdominal
areas, the device does not exceed
pressure of 120 mmHg;
5. Device is not intended to heat or
cool a patient; and
6. Device is not intended to be used
for direct skin contact.
----------------------------------------------------------------------------------------------------------------
If the proposed exemptions for the device types listed in table 2
are finalized, FDA will assign new product codes to the device types
that will be exempt subject to the corresponding partial limitations of
exemptions in order to ensure that these devices can be identified
distinctly from devices that do not fall within the partial limitations
of exemptions (which will continue to be assigned to the existing
product code). Exempt and non-exempt devices within a device type will
therefore have different product codes.
V. Reference
The following reference is on display at the Dockets Management
Staff (see ADDRESSES) 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Although FDA
verified the website address 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 <a href="https://www.fda.gov/media/72685/download">https://www.fda.gov/media/72685/download</a>.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2026-02377 Filed 2-5-26; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on February 6, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.