Notice2026-08499
Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments
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Published
May 1, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing its intent to exempt from premarket notification requirements certain class II clinical toxicology test system devices. 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 further consider whether the exemption described in this notice should be modified prior to publication of its final determination in the Federal Register.
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<title>Federal Register, Volume 91 Issue 84 (Friday, May 1, 2026)</title>
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[Federal Register Volume 91, Number 84 (Friday, May 1, 2026)]
[Notices]
[Pages 23427-23431]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-08499]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-4268]
Medical Devices; Exemptions From Premarket Notification: Certain
Class II Devices; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing its
intent to exempt from premarket notification requirements certain class
II clinical toxicology test system devices. 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 further consider whether the
exemption described in this notice should be modified prior to
publication of its final determination in the Federal Register.
DATES: Either electronic or written comments on the notice must be
submitted by June 30, 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 June 30, 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.''
[[Page 23428]]
Instructions: All submissions received must include the Docket No.
FDA-2026-N-4268 for ``Medical Devices; Exemptions from Premarket
Notification: Certain 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 Eastern Time, 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.'' FDA 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: Joseph Kotarek, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3528, Silver Spring, MD 20993, 301-796-2718,
<a href="/cdn-cgi/l/email-protection#6822071b0d18004623071c091a0d03280e0c094600001b460f071e"><span class="__cf_email__" data-cfemail="0943667a6c79612742667d687b6c62496f6d682761617a276e667f">[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, postmarket surveillance, patient
registries, development and dissemination of guidelines,
recommendations, and other appropriate actions FDA (the Agency) 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 (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 (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 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 FDA's 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.
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.
[[Page 23429]]
Exemptions from premarket notification for certain clinical
toxicology test systems falling within the regulations identified in
the instant notice,\1\ in addition to exemptions for other device
types, were proposed and finalized in 2017. FDA published its initial
notice for these clinical toxicology test systems 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 a 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). In the
Federal Register of December 30, 2019 (84 FR 71794), FDA amended the
relevant sections of the CFR to reflect the exemptions finalized in
July 2017.
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\1\ See table 1 for the device types.
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FDA is now publishing this notice to announce its intent to expand
the 510(k) exemptions in the classification regulations included in
this notice to additional devices within the device types, and to
request public comment, in accordance with section 510(m)(2) of the
FD&C Act. If finalized, the expansion of these exemptions will decrease
regulatory burdens on the medical device industry and will eliminate
private costs and expenditures required to comply with certain Federal
regulations. 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 Generally Considers for Exemption
There are a number of factors FDA generally considers 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, titled ``Procedures for Class II Device Exemptions from Premarket
Notification, Guidance for Industry and CDRH Staff'' (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
general limitations of exemptions. FDA's determinations that premarket
notification is not necessary to provide a reasonable assurance of
safety and effectiveness for class II devices are often based 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 exemptions from premarket notification requirements for the
class II device types listed in table 1 apply only to those devices
that have existing or reasonably foreseeable characteristics of
commercially distributed devices within that generic type or, in the
case of in vitro diagnostics, only to the extent that misdiagnosis as a
result of using the device would not be associated with high morbidity
or mortality (see Sec. 862.9 (21 CFR 862.9) (titled ``Limitations of
exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic
Act (the act)''). Thus, 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 exceeds
any of the limitations of exemptions described in Sec. 862.9.
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 specific devices within a device
type.
Currently, the classification regulations included in this notice
already include an exemption from 510(k) requirements (subject to the
general limitations in Sec. 862.9 as discussed in section III.A of
this notice) ``provided the test system is intended for employment and
insurance testing and includes a statement in the labeling that the
device is intended solely for use in employment and insurance
testing,'' and as long as the device is not intended for use in Federal
drug testing programs.\2\ In this notice, FDA is announcing its intent
to remove the exception to the 510(k) exemption for devices intended
for Federal drug testing programs. As such, under the proposal, devices
in the device types listed in table 1 would be exempt from 510(k)
requirements even if intended for use in Federal drug testing programs
as long as they do not exceed any of the general limitations of
exemptions in Sec. 862.9, and provided the test system is intended for
employment and insurance testing and includes a statement in the
labeling that the device is intended solely for use in employment and
insurance testing, as described in table 1.
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\2\ 21 CFR 862.3100, 862.3150, 862.3170, 862.3250, 862.3270,
862.3580, 862.3610, 862.3620, 862.3630, 862.3640, 862.3650,
862.3700, 862.3870, and 862.3910; 84 FR 71794. Federal drug testing
programs include, for example, programs run by the Substance Abuse
and Mental Health Services Administration (SAMHSA), the Department
of Transportation (DOT), and the U.S. military.
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When FDA finalized the partial exemptions from 510(k) requirements
that are currently included in the classification regulations listed in
table 1, FDA assigned new product codes to ensure that exempt and non-
exempt devices within a device type would have separate product codes
(82 FR 31976 at 31977). If the proposed expansion of the 510(k)
exemptions described in this notice is finalized, FDA will continue to
use the previously established product codes; however, the definitions
of the product codes for exempt devices will be modified to accurately
reflect the scope of the exemption,\3\ and devices which are newly
exempt will change from a non-exempt product code to the corresponding
exempt product code.
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\3\ For example, the current definition for product code PUX
(Test, Amphetamine, Employment and Insurance Testing, Exempt)
includes a reference to 82 FR 31976 (the action establishing the
exemption). Should the proposal in this notice be finalized, this
reference, and corresponding ones for the other exempt product
codes, would be replaced with a reference to the Federal Register
document codifying the expanded scope of the exemption.
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IV. List of Class II Devices
FDA has made an initial determination that premarket notification
is no longer necessary to provide a reasonable assurance of safety and
effectiveness for these devices when they are intended for Federal drug
testing programs (see ``Proposed Partial Limitations'' listed in table
1 of this notice). If the proposed expansion of the 510(k) exemptions
described in this
[[Page 23430]]
notice is finalized, devices in the device types listed in table 1
would not require premarket notification under section 510(k) of the
FD&C Act when they are intended for Federal drug testing programs, so
long as they do not exceed the proposed partial limitations of
exemptions specified in table 1 and the corresponding general
limitations of exemptions described in section III.A of this notice.
Table 1--Proposed Exempt Class II Devices Subject to General Limitations and Partial Limitations
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Generic device Exempt Non-exempt Current partial Proposed partial
21 CFR section type product code product codes limitations limitations
----------------------------------------------------------------------------------------------------------------
862.3100...... Amphetamine PUX.......... DIT, DJL, DJP, Exemption is limited to Exemption is limited
test system. DKZ, DNI, DOD, test systems intended to to test systems
DPJ, NFT, NVI, measure amphetamine for intended to measure
OIW. employment and insurance amphetamine for
testing and for which employment and
the test system labeling insurance testing
includes a statement and for which the
that the device is test system
intended solely for labeling includes a
employment and insurance statement that the
testing, and does not device is intended
include devices intended solely for
for Federal drug testing employment and
programs. insurance testing.
862.3150...... Barbiturate PUY.......... DIS, DJN, DKN, Exemption is limited to Exemption is limited
test system. DKX, DLX, DMF, test systems intended to to test systems
KZY, PTH. measure barbiturates for intended to measure
employment and insurance barbiturates for
testing and for which employment and
the test system labeling insurance testing
includes a statement and for which the
that the device is test system
intended solely for labeling includes a
employment and insurance statement that the
testing, and does not device is intended
include devices intended solely for
for Federal drug testing employment and
programs. insurance testing.
862.3170...... Benzodiazepine PUZ.......... JXM, KZZ, LAA, Exemption is limited to Exemption is limited
test system. LAB, NFV. test systems intended to to test systems
measure any of the intended to measure
benzodiazepine compounds any of the
for employment and benzodiazepine
insurance testing and compounds for
for which the test employment and
system labeling includes insurance testing
a statement that the and for which the
device is intended test system
solely for employment labeling includes a
and insurance testing, statement that the
and does not include device is intended
devices intended for solely for
Federal drug testing employment and
programs. insurance testing.
862.3250...... Cocaine and PVA.......... DIN, DIO, DIR, Exemption is limited to Exemption is limited
cocaine DLN, DMN, DNG, test systems intended to to test systems
metabolite DOM, JXO, KLN, measure cocaine and a intended to measure
test system. LAC, NFY. cocaine metabolite cocaine and a
(benzoylecgonine) for cocaine metabolite
employment and insurance (benzoylecgonine)
testing and for which for employment and
the test system labeling insurance testing
includes a statement and for which the
that the device is test system
intended solely for labeling includes a
employment and insurance statement that the
testing, and does not device is intended
include devices intended solely for
for Federal drug testing employment and
programs. insurance testing.
862.3270...... Codeine test PVB.......... DLD, LAD, LAE.. Exemption is limited to Exemption is limited
system. test systems intended to to test systems
measure codeine for intended to measure
employment and insurance codeine for
testing and for which employment and
the test system labeling insurance testing
includes a statement and for which the
that the device is test system
intended solely for labeling includes a
employment and insurance statement that the
testing, and does not device is intended
include devices intended solely for
for Federal drug testing employment and
programs. insurance testing.
862.3580...... Lysergic acid PVC.......... DLB, DOL....... Exemption is limited to Exemption is limited
diethylamide test systems intended to to test systems
(LSD) test measure LSD for intended to measure
system. employment and insurance LSD for employment
testing and for which and insurance
the test system labeling testing and for
includes a statement which the test
that the device is system labeling
intended solely for includes a
employment and insurance statement that the
testing, and does not device is intended
include devices intended solely for
for Federal drug testing employment and
programs. insurance testing.
862.3610...... Methamphetamine PVD.......... DJC, LAF, LAG, Exemption is limited to Exemption is limited
test system. NGG. test systems intended to to test systems
measure methamphetamine intended to measure
for employment and methamphetamine for
insurance testing and employment and
for which the test insurance testing
system labeling includes and for which the
a statement that the test system
device is intended labeling includes a
solely for employment statement that the
and insurance testing, device is intended
and does not include solely for
devices intended for employment and
Federal drug testing insurance testing.
programs.
862.3620...... Methadone test PVE.......... DIW, DJR, DKR, Exemption is limited to Exemption is limited
system. DMB, DNT, DPP, test systems intended to to test systems
PTG. measure methadone for intended to measure
employment and insurance methadone for
testing and for which employment and
the test system labeling insurance testing
includes a statement and for which the
that the device is test system
intended solely for labeling includes a
employment and insurance statement that the
testing, and does not device is intended
include devices intended solely for
for Federal drug testing employment and
programs. insurance testing.
862.3630...... Methaqualone PVF.......... KXS............ Exemption is limited to Exemption is limited
test system. test systems intended to to test systems
measure methaqualone for intended to measure
employment and insurance methaqualone for
testing and for which employment and
the test system labeling insurance testing
includes a statement and for which the
that the device is test system
intended solely for labeling includes a
employment and insurance statement that the
testing, and does not device is intended
include devices intended solely for
for Federal drug testing employment and
programs. insurance testing.
[[Page 23431]]
862.3640...... Morphine test PVG.......... DIQ, DJJ, DLR, Exemption is limited to Exemption is limited
system. DMY, DNA, DNK, test systems intended to to test systems
DOE, DOK, DPK, measure morphine and its intended to measure
NGI. analogs for employment morphine and its
and insurance testing analogs for
and for which the test employment and
system labeling includes insurance testing
a statement that the and for which the
device is intended test system
solely for employment labeling includes a
and insurance testing, statement that the
and does not include device is intended
devices intended for solely for
Federal drug testing employment and
programs. insurance testing.
862.3650...... Opiate test PVH.......... DJF, DJG, DKT, Exemption is limited to Exemption is limited
system. DLT, LAH, LAI, test systems intended to to test systems
NGL. measure any of the intended to measure
addictive narcotic pain- any of the
relieving opiate drugs addictive narcotic
for employment and pain-relieving
insurance testing and opiate drugs for
for which the test employment and
system labeling includes insurance testing
a statement that the and for which the
device is intended test system
solely for employment labeling includes a
and insurance testing, statement that the
and does not include device is intended
devices intended for solely for
Federal drug testing employment and
programs. insurance testing.
862.3700...... Propoxyphene PVI.......... DPN, JXN, LAJ, Exemption is limited to Exemption is limited
test system. LAK, QBF. test systems intended to to test systems
measure propoxyphene for intended to measure
employment and insurance propoxyphene for
testing and for which employment and
the test system labeling insurance testing
includes a statement and for which the
that the device is test system
intended solely for labeling includes a
employment and insurance statement that the
testing, and does not device is intended
include devices intended solely for
for Federal drug testing employment and
programs. insurance testing.
862.3870...... Cannabinoid PVJ.......... DKE, LAT, LDJ, Exemption is limited to Exemption is limited
test system. NFW. test systems intended to to test systems
measure any of the intended to measure
cannabinoids for any of the
employment and insurance cannabinoids for
testing and for which employment and
the test system labeling insurance testing
includes a statement and for which the
that the device is test system
intended solely for labeling includes a
employment and insurance statement that the
testing, and does not device is intended
include devices intended solely for
for Federal drug testing employment and
programs. insurance testing.
862.3910...... Tricyclic PVK.......... LFG, LFH, LFI, Exemption is limited to Exemption is limited
antidepressant MLK, QAW. test systems intended to to test systems
drugs test measure any of the intended to measure
system. tricyclic antidepressant any of the
drugs for employment and tricyclic
insurance testing and antidepressant
for which the test drugs for
system labeling includes employment and
a statement that the insurance testing
device is intended and for which the
solely for employment test system
and insurance testing, labeling includes a
and does not include statement that the
devices intended for device is intended
Federal drug testing solely for
programs. employment and
insurance testing.
----------------------------------------------------------------------------------------------------------------
V. 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.
VI. 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>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-08499 Filed 4-30-26; 8:45 am]
BILLING CODE 4164-01-P
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