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Rule2026-20448

Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems

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Published

October 6, 2026

Effective

October 6, 2026

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA) is publishing an order setting forth its final determination to exempt certain class II clinical toxicology test systems from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k) requirements, subject to certain limitations, is immediately in effect for such devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is amending the classification language within the Code of Federal Regulations (CFR) for certain class II clinical toxicology test systems to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Full Text

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<title>Federal Register, Volume 91 Issue 192 (Tuesday, October 6, 2026)</title>
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[Federal Register Volume 91, Number 192 (Tuesday, October 6, 2026)]
[Rules and Regulations]
[Pages 63478-63487]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20448]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. FDA-2026-N-4268]

Medical Devices; Exemptions From Premarket Notification: Class II
Devices; Certain Clinical Toxicology Test Systems

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA) is publishing an order
setting forth its final determination to exempt certain class II
clinical toxicology test systems from premarket notification (510(k))
requirements, subject to certain limitations. This exemption from
510(k) requirements, subject to certain limitations, is immediately in
effect for such devices. This exemption will decrease regulatory
burdens on the medical device industry and will eliminate private costs
and expenditures required to comply with certain Federal regulations.
FDA is amending the classification language within the Code of Federal
Regulations (CFR) for certain class II clinical toxicology test systems
to reflect this final determination. FDA is publishing this order in
accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: This order is effective October 6, 2026.

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#23694c5046534b0d684c5742514648634547420d4b4b500d444c55"><span class="__cf_email__" data-cfemail="0943667a6c79612742667d687b6c62496f6d682761617a276e667f">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

Under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and FDA's
implementing regulations in part 807, subpart E of the CFR (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 510(k) to FDA. The device may not be marketed
until FDA (we or the Agency) 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. A 510(k) 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) of the FD&C Act. 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 510(k) is not necessary to assure the safety and
effectiveness of the device. FDA must publish in the Federal Register a
notice of intent to exempt a device, or of the petition, and provide a
60-day period for public comment.
Exemptions from premarket notification for certain clinical
toxicology test systems, 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.
In the Federal Register of May 1, 2026 (91 FR 23427) (``the May
2026 notice''), FDA published a notice announcing its intent to expand
the exemptions from premarket notification requirements for certain
class II clinical toxicology test systems to additional devices within
the device types and provided 60 days for interested persons to submit
comments

[[Page 63479]]

by June 30, 2026. Specifically, FDA announced its intent to remove the
exception for devices intended for Federal drug testing programs from
the 510(k) exemptions for the clinical toxicology test systems
identified in the May 2026 notice. FDA received comments from
approximately 70 commenters during the 60-day comment period. FDA's
responses to the timely received comments can be found in section III
of this order. This final order sets forth our final determination to
expand the exemptions for the class II clinical toxicology test systems
that were the subject of the May 2026 notice. Through this action, FDA
is amending the language for the identified classification regulations
(21 CFR 862.3100(b), 862.3150(b), 862.3170(b), 862.3250(b),
862.3270(b), 862.3580(b), 862.3610(b), 862.3620(b), 862.3630(b),
862.3640(b), 862.3650(b), 862.3700(b), 862.3870(b), and 862.3910(b)) to
reflect this final determination.\1\
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\1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
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This final order is expected to result in decreased 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'' (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 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 IV of this notice.

III. Comments on the Proposed Exemptions and FDA's Response

In the May 2026 notice, FDA announced its intent to expand the
510(k) exemptions for certain class II clinical toxicology test systems
to additional devices within the device types, subject to certain
limitations, upon its own initiative, and provided opportunity for
interested persons to submit comments by June 30, 2026. After reviewing
the comments received, FDA is now providing its final determination on
expanding the 510(k) exemptions for the class II clinical toxicology
test systems listed in table 1 to include devices intended for use in
Federal drug testing programs, subject to certain limitations as
identified in this order. FDA is also amending the codified language
for the classification regulations for the class II clinical toxicology
test systems listed in table 1 to reflect this final determination.
In response to the May 2026 notice announcing FDA's intent to
expand the 510(k) exemptions for certain class II clinical toxicology
test systems, FDA received comments from approximately 70 commenters,
including individuals, trade organizations, regulated industry, labor
unions, and other interested parties. Some of the comments contained
one or more comments on one or more issues.
The order of the comments and our response to them is purely for
organizational purposes and does not signify the comment's value or
importance or the order in which comments were received. Certain
comments are grouped together under a single number because the subject
matter is similar. Please note that in some cases we separated
different issues discussed by the same commenter and designated them as
distinct comments for purposes of our responses.
(Comment 1) The majority of commenters expressed support for the
proposed expansion of the 510(k) exemptions. Commenters stated that
they believed the proposal, if finalized, would reduce unnecessary
regulatory burdens. Commenters noted that device manufacturers would no
longer need to invest time and resources into 510(k) submissions for
newly exempt test systems. Many commenters stated that there would be
no drop-off in the quality or accuracy of test systems used in Federal
drug testing programs should the exemptions be finalized, and one
commenter added that unnecessary barriers to adoption of clinical
toxicology test systems in Federal drug testing programs are a public
safety concern. Several commenters described the proposal as ``a
practical, overdue, and well-reasoned step toward a federal drug
testing framework that reflects current science and operational
reality.''
(Response 1) FDA agrees with the commenters' support for the
expansion of the 510(k) exemptions. In this order, FDA is finalizing
the proposed exemptions without modification.
(Comment 2) Some commenters requested clarification regarding the
scope of the proposed expanded 510(k) exemptions included in the May
2026 notice. Specifically, commenters asked whether a test system would
be exempted from 510(k) requirements by the exemptions proposed in the
May 2026 notice when the test system measures a different analyte, uses
a different methodology, or has a different cutoff concentration than
all already cleared devices in a generic device type included in the
May 2026 notice. Another commenter asked FDA to clarify that a
``Federal-program-specific predicate is not required for an eligible
test system to fall within the exemption.'' Many comments encouraged
FDA to liberally interpret the boundaries of the finalized exemptions.
(Response 2) FDA encourages commenters to review the finalized
partial limitations of exemption discussed in section IV of this order
as well as 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)''). Under Sec. 862.9(a), a device that otherwise

[[Page 63480]]

would fall within a 510(k) exemption is not exempt from 510(k)
requirements when ``[t]he device is intended for a use different from
the intended use of a legally marketed device in that generic type of
device.'' As reflected in table 1, a test system must be intended for
employment and insurance testing to fall within the 510(k) exemptions
for the generic device types that are the subject of this order.
Additionally, under Sec. 862.9(b), such a device is not exempt from
510(k) requirements when the ``device operates using a different
fundamental scientific technology than a legally marketed device in
that generic type of device.'' These general limitations of exemption
apply to generic device types exempted from 510(k) requirements by this
order as well as other generic device types classified in 21 CFR part
862.
Whether a specific test system is or is not exempt from 510(k)
requirements depends on the specifics of the test system. FDA
encourages manufacturers who have questions about whether a specific
test system is exempt from 510(k) requirements to discuss their test
system with FDA. Manufacturers may consider submitting a request for
information under section 513(g) of the FD&C Act (21 U.S.C. 360c(g)).
For more information regarding section 513(g) of the FD&C Act requests
for information, please see FDA's guidance document titled ``FDA and
Industry Procedures for Section 513(g) Requests for Information under
the Federal, Food, Drug, and Cosmetic Act'' (Ref. 2).
(Comment 3) Multiple commenters requested that FDA clarify its
authority around Federal drug testing programs and how this authority
interacts with that of the Substance Abuse and Mental Health Services
Administration (SAMHSA) and the National Laboratory Certification
Program (NLCP). Other commenters requested that FDA, SAMHSA, and the
NLCP coordinate to reduce regulatory requirements.
(Response 3) FDA's Center for Devices and Radiological Health aims
to assure that patients and providers have safe, effective, and high-
quality medical devices and safe radiation-emitting products. The term
``device'' is defined under section 201(h) of the FD&C Act (21 U.S.C.
321(h)) to mean, in relevant part, ``an instrument, apparatus,
implement, machine, contrivance, implant, in vitro reagent, or other
similar or related article, including any component, part, or
accessory, which is-- . . . (B) intended for use in the diagnosis of
disease or other conditions, or in the cure, mitigation, treatment, or
prevention of disease, in man or other animals . . . and which does not
achieve its primary intended purposes through chemical action within or
on the body of man or other animals and which is not dependent upon
being metabolized for the achievement of its primary intended
purposes.''
FDA does not administer or implement Federal drug testing programs.
However, FDA regulates test systems used in Federal drug testing
programs. Manufacturers and importers of devices such as clinical
toxicology test systems may be subject to a variety of requirements
under the FD&C Act and FDA's regulations, including establishment
registration, device listing, 510(k), labeling, quality management
system, and medical device reporting requirements. Class II devices
that are 510(k) exempt are still subject to other applicable
requirements.
SAMHSA's Division of Workplace Programs oversees Federal drug-free
workplace programs, which aim to eliminate illicit drug use in Federal
workplaces. It also oversees the NLCP, which certifies laboratories to
conduct forensic drug testing for Federal agencies and federally
regulated industries. SAMHSA has published mandatory guidelines for
drug testing for urine (88 FR 70768) and for oral fluid (88 FR 70814).
FDA agrees that FDA, SAMHSA, and the NLCP should coordinate to best
protect the public health, which may include reducing regulatory
requirements where appropriate. In this final order, FDA is expanding
the 510(k) exemptions for certain clinical toxicology test systems to
include devices intended for Federal drug testing programs. Upon
publication of this order, a 510(k) will no longer be required for such
devices (subject to the general limitations of exemption under Sec.
862.9 and the partial limitations of exemption identified in table 1).
(Comment 4) Two commenters stated that test systems used for
Federal drug testing programs are not devices because they do not meet
the definition of a device in the FD&C Act, and therefore, these test
systems are not subject to FDA regulation.
(Response 4) FDA disagrees. As previously discussed in our response
to comment 3, as defined in section 201(h) of the FD&C Act, the term
``device'' means, in relevant part, ``an instrument, apparatus,
implement, machine, contrivance, implant, in vitro reagent, or other
similar or related article, including any component, part, or
accessory, which is-- . . . (B) intended for use in the diagnosis of
disease or other conditions, or in the cure, mitigation, treatment, or
prevention of disease, in man or other animals . . . and which does not
achieve its primary intended purposes through chemical action within or
on the body of man or other animals and which is not dependent upon
being metabolized for the achievement of its primary intended
purposes.'' Drugs of abuse test systems, even when used for employment
and insurance testing, are intended to provide information about a
condition, namely, whether drugs of abuse are being used or have been
used by the subject (see 65 FR 18230 at 18232). Therefore, the test
systems newly exempted in this order are devices.
(Comment 5) Some commenters stated that the May 2026 notice did not
specify what standards would replace 510(k) requirements for the test
systems newly exempted by this order.
(Response 5) For clinical toxicology test systems that are newly
exempted in this order, FDA has determined that a 510(k) is not
necessary to assure the safety and effectiveness of the device, in
accordance with section 510(m)(2) of the FD&C Act. Clinical toxicology
test systems of the types listed in table 1 are therefore exempt from
510(k) requirements, including when such test systems are intended for
use in Federal drug testing programs, upon publication of this order,
subject to the general limitations of exemption under Sec. 862.9 and
the partial limitations of exemption identified in table 1. No
standards or additional requirements replace 510(k) requirements for
these devices. However, as discussed in our response to comment 3,
510(k) exempt devices remain subject to other applicable regulatory
requirements, including SAMHSA's mandatory guidelines, to the extent
they are used in Federal drug testing programs.
(Comment 6) Many commenters stated that finalizing the expansion of
the 510(k) exemptions proposed in the May 2026 notice is a necessary
step for the implementation of oral fluid testing in Federal drug
testing programs, including those programs administered by SAMHSA and
the Department of Transportation (DOT). Some comments questioned why,
or expressed frustration that, oral fluid testing has not yet been
``approved'' for use in these programs. Other commenters stated that
delays in implementing oral fluid testing in Federal drug testing
programs have had, and will continue to have, effects on transportation
safety.
(Response 6) FDA is expanding the 510(k) exemptions for the
clinical toxicology test systems identified in table 1 of this order
because, in consideration of the factors listed in section II of this
order, FDA has

[[Page 63481]]

determined that a 510(k) is not necessary to assure the safety and
effectiveness of these devices, subject to the general limitations of
exemption under Sec. 862.9 and the partial limitations of exemption
identified in table 1. While FDA understands that the expansion of the
exemptions finalized in this order may facilitate the use of oral fluid
testing in Federal drug testing programs, FDA does not oversee Federal
drug testing programs (as noted in our response to comment 3) and so
does not decide whether oral fluid testing may be used in such
programs.
(Comment 7) Some commenters stated that finalizing the expansion of
the 510(k) exemptions proposed in the May 2026 notice is a necessary
step for the implementation of hair testing in Federal drug testing
programs, including those programs administered by SAMHSA and DOT.
(Response 7) As noted in our response to comment 3, FDA does not
oversee Federal drug testing programs and so does not decide whether
hair testing may be used in such programs. Please see our response to
comment 6.
(Comment 8) Multiple commenters stated that in addition to the
510(k) exemptions proposed in the May 2026 notice, FDA should exempt
additional device types from 510(k) requirements, including test
systems for phencyclidine (PCP); all class II clinical toxicology test
systems intended for employment or insurance testing; all test systems
used in Federal drug testing programs, including automatic additions
when new drugs are added to Federal drug testing programs; unspecified
additional test systems not intended for employment and insurance
testing; and oral fluid collection devices.
(Response 8) These comments are outside the scope of what was
proposed in the May 2026 notice and are, therefore, outside the scope
of this final order. FDA notes that the 510(k) exemptions in this order
are being finalized under the authority of section 510(m)(2) of the
FD&C Act, which allows FDA to exempt only class II devices from 510(k)
requirements, yet some of the additional device types suggested by
comments have not been classified into class II. In addition, some of
the device types suggested by the comments have different safety and
effectiveness profiles (e.g., oral fluid collection devices) than the
test systems for which 510(k) exemptions are being finalized in this
order. FDA has not made a determination that a 510(k) is not necessary
to assure the safety and effectiveness of oral fluid collection
devices; thus, finalizing a 510(k) exemption for them would not be
appropriate. FDA notes that there are 510(k)-cleared oral fluid
collection devices that may be used with test systems for any drug of
abuse analyte.
As indicated in table 1, the list of device types for which FDA is
expanding 510(k) exemptions in this order is unchanged from the list
proposed in the May 2026 notice.
(Comment 9) One commenter requested clarification regarding product
code DJG being listed in the non-exempt product codes in the May 2026
notice and whether fentanyl test systems under product code DJG are
exempt from 510(k) requirements if they are intended solely for
employment and insurance testing. A different commenter requested
clarification regarding whether fentanyl test systems are included in
this order because fentanyl test systems were not mentioned by name in
the May 2026 notice.
(Response 9) While fentanyl test systems and test systems for other
opioids were not mentioned by name in the May 2026 notice, such test
systems generally fall within the classification regulation for opiate
test systems (Sec. 862.3650), which is one of the generic device types
for which FDA is expanding the 510(k) exemptions in this order. Under
Sec. 862.3650(a), an opiate test system is a device intended to
measure any of the addictive narcotic pain-relieving opiate drugs in
blood, serum, urine, gastric contents, and saliva. Section 862.3650(a)
also defines an opiate as any natural or synthetic drug that has
morphine-like pharmacological actions. Test systems intended to test
for fentanyl generally fall under this regulation. Therefore, fentanyl
test systems intended for Federal drug testing programs are included in
the 510(k) exemptions finalized in this order.
Test systems that previously were designated under product code DJG
will now fall under product code PVH and are 510(k) exempt if they do
not exceed the limitations of exemption discussed in section IV of this
order, including the limitation that the test system be intended for
use solely in employment or insurance testing. For each product code
listed in the ``Non-Exempt Product Codes'' column of table 1 of this
order, there is a corresponding product code under the ``Exempt Product
Code'' column in the same row. When a device in the generic device type
does not exceed the limitations of exemption discussed in section IV of
this order, then that device is 510(k) exempt and falls under the
corresponding exempt product code.
(Comment 10) One comment stated that the 510(k) exemption for
opiate test systems (exempt product code PVH) should not include test
systems for fentanyl and its analogs. This commenter implied that it is
uniquely difficult to accurately test for fentanyl and its analogs
compared to other drugs of abuse, and therefore, fentanyl test systems
are not appropriate for 510(k) exemption.
(Response 10) FDA disagrees. FDA's classification of opiate test
systems includes test systems intended to test for fentanyl (see our
response to Comment 9), and FDA has previously exempted opiate test
systems, including test systems intended to test for fentanyl, from
510(k) requirements subject to certain limitations. FDA does not
believe that fentanyl test systems raise unique considerations above
and beyond those that apply to other test systems in this order. In
consideration of the factors which 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 (see section II of this
order), FDA has determined to expand the 510(k) exemption that already
exists for opiate test systems (including test systems intended to test
for fentanyl) to include test systems intended for Federal drug testing
programs.
(Comment 11) Some commenters requested additional specificity
regarding the labeling language needed to avoid exceeding the partial
limitations of exemption applicable to all exemptions in this order,
which state that the exemptions are limited to tests ``for which the
test system labeling includes a statement that the device is intended
solely for employment and insurance testing.''
(Response 11) FDA does not believe it is necessary or appropriate
to provide further specificity regarding the labeling statement
identified in the partial limitations of exemption for the clinical
toxicology test systems covered by this order. The commenters did not
explain why they thought clarification of this statement was necessary
or how the partial limitation as proposed in the May 2026 notice was
unclear. A partial limitation of exemption indicates that FDA has
determined that premarket notification is necessary to provide a
reasonable assurance of safety and effectiveness for devices that
exceed the limitation. Regarding the labeling statement at issue, FDA
has determined that premarket notification is necessary if the labeling
for the device does not indicate that the device is intended solely for
employment and insurance testing, but FDA has not determined

[[Page 63482]]

that specific verbiage must be used for that statement. We therefore
decline to provide additional specificity regarding the labeling
statement identified in the partial limitations of exemption for these
devices.
(Comment 12) Some commenters requested that FDA exercise
enforcement discretion regarding compliance with labeling requirements
for test systems that were previously 510(k) exempt for employment and
insurance testing, and that are labeled as not intended for use in
Federal drug testing programs, when now intended for use in Federal
drug testing programs consistent with the expanded 510(k) exemptions
finalized by this order.
(Response 12) FDA declines to adopt a general enforcement
discretion policy as requested by these commenters. FDA expects the
clinical toxicology test systems covered by this order, whether exempt
from 510(k) requirements or not, to be labeled in accordance with all
applicable labeling requirements under the FD&C Act and 21 CFR parts
801 and 809, including that the labeling not be false or misleading.
(Comment 13) Multiple commenters requested that FDA exercise
enforcement discretion regarding 510(k) requirements for any test
system used in Federal drug testing programs and subject to NLCP
requirements, even when such test systems have not been exempted from
510(k) requirements. Many of these commenters also requested that FDA
``stop regulating'' devices intended for use in Federal drug testing
programs and ``transfer'' any FDA authority over Federal drug testing
programs to NLCP. In contrast, at least one commenter recommended that
if FDA were ``to stop regulating'' test systems intended for use in
Federal drug testing programs, FDA should not transfer its
responsibilities to NLCP.
(Response 13) FDA declines to adopt a general enforcement
discretion policy for 510(k) requirements for all test systems used in
Federal drug testing programs. FDA is expanding the exemptions from
510(k) requirements for clinical toxicology test systems identified in
this order to include test systems intended for use in Federal drug
testing programs based on a determination that a 510(k) is not
necessary to assure the safety and effectiveness of these devices
(subject to the general limitations of exemption under Sec. 862.9 and
the partial limitations of exemption identified in table 1). To the
extent these comments are requesting or recommending that jurisdiction
over these tests systems be transferred from FDA to another Federal
agency, such comments are outside the scope of this final order and
would require statutory changes by Congress. In addition, FDA considers
aspects of these comments to arise from a mistaken premise that FDA
oversees Federal drug testing programs and can transfer that authority
to another agency. That is not the case. As noted in response 3, FDA
regulates devices used in Federal drug testing programs but does not
oversee Federal drug testing programs themselves.
(Comment 14) Some commenters stated their belief that if the
expansion of the exemptions proposed in the May 2026 notice is
finalized, the quality of test systems could decrease, including worse
accuracy and reliability, because the devices will no longer undergo
premarket review. One commenter suggested expanding the exemptions
could lead to decreased confidence in the accuracy of Federal drug
testing. Other commenters opposed the expansion of the 510(k)
exemptions because the commenters believed expanding the exemptions
could lead to increased medical device fraud.
(Response 14) FDA disagrees that the quality of test systems
available for Federal drug testing programs will decrease due to the
expansion of the exemptions from 510(k) requirements finalized in this
order or that fraudulent devices will enter the market because of the
expansion of the exemptions. FDA has determined that premarket
notification is not necessary to assure the safety and effectiveness of
the class II clinical toxicology test systems subject to the
limitations outlined in table 1. While 510(k) exempt test systems
intended for use in Federal drug testing programs generally will no
longer be subject to FDA premarket review requirements, they remain
subject to other requirements under the FD&C Act and FDA's regulations
as discussed in our response to comment 3, including quality management
system requirements, medical device reporting requirements, and
labeling requirements. In addition, laboratories that test samples for
Federal drug testing programs are subject to requirements associated
with Federal drug testing programs and overseen by SAMHSA, including
the mandatory guidelines. These requirements may allow interested
parties to remain confident in the accuracy of Federal drug testing
programs.
(Comment 15) Some commenters did not support the expansion of the
510(k) exemptions proposed in the May 2026 notice because they believed
that the expansion could lead to increased highway safety incidents,
including increased crashes, injuries, and/or loss of life. The
commenters believed that without premarket review, new exempt test
systems that are not currently on the market may fail to correctly
detect positive samples that would be detected by test systems
currently used in Federal drug testing programs. Commenters also
expressed similar concerns about other industries subject to DOT
testing, including aviation, rail, transit, and maritime industries.
(Response 15) FDA disagrees with comments that suggest that
expanding the 510(k) exemptions to include test systems intended for
use in Federal drug testing programs will likely cause harm by leading
to an increased frequency of highway crashes or other mishaps caused by
impaired/intoxicated workers. These comments appear to be premised on
the belief that once premarket review of certain test systems intended
for use in Federal drug testing programs is no longer required, the
test systems will less accurately detect positive samples. However, as
noted in our response to comment 14, we disagree with that premise,
including because other applicable requirements will help to ensure the
safety and effectiveness of these test systems and the accuracy of
testing conducted under Federal drug testing programs. In addition to
the controls imposed by SAMHSA as discussed in response 14, applicable
requirements under the FD&C Act and FDA regulations besides premarket
review requirements will continue to apply to the test systems being
made 510(k) exempt in this order. For example, manufacturers of test
systems exempted from 510(k) requirements by this order remain subject
to establishment registration, device listing, quality management
system, and device labeling requirements, among other requirements and
as applicable (see generally 21 CFR parts 801, 803, 807, 809, and 820).
FDA therefore does not believe this order will result in newly exempted
test systems lacking reasonable effectiveness in detecting positive
samples.
(Comment 16) One commenter stated that they were opposed to the
expansion of the 510(k) exemptions proposed in the May 2026 notice
because, in their view, FDA caused injury in other contexts by lifting
restrictions on medications, and they believed that expansion of the
exemptions could similarly cause injury.
(Response 16) We are not clear as to what actions or events the
commenter was referencing when stating that FDA has ``gotten people
killed or severely sick'' by lifting restrictions on medications.
Nevertheless, FDA disagrees that expanding the 510(k)

[[Page 63483]]

exemptions for the clinical toxicology test systems identified in this
order to include when such test systems are intended for use in Federal
drug testing programs is likely to cause harm to patients. The
expansion of the exemptions only applies to test systems that are
intended for employment and insurance testing. While these test systems
are intended to provide information about a condition, namely, whether
drugs of abuse are being used or have been used by the subject, these
test systems are not intended to be used to make treatment decisions.
Therefore, FDA does not agree that the expansion of the exemptions
finalized in this order is likely to cause harm to patients.
(Comment 17) A few commenters stated that finalizing the expansion
of the exemptions proposed in the May 2026 notice could cause potential
disruption to existing Federal drug testing programs or unintended
compliance challenges for interested parties in the drug testing
industry.
(Response 17) FDA disagrees with these comments. Tests systems
intended for use in Federal drug testing programs that were previously
authorized by FDA can continue to be used in such programs (assuming
compliance with other applicable laws). The final order will enable
additional test systems intended for Federal drug testing programs to
be legally marketed without first obtaining 510(k) clearance from FDA.
Therefore, FDA does not agree that finalization of this order could
cause disruption to existing Federal drug testing programs.
(Comment 18) One commenter alleged that non-Federal workplace drug
testing programs are often poorly run, and that the expansion of the
510(k) exemptions for the clinical toxicology test systems identified
in this order, to include such test systems when intended for use in
Federal drug testing programs, would open Federal drug testing programs
to poor management seen in these other programs.
(Response 18) FDA does not agree that the finalization of the
exemptions in this order will likely affect the management quality of
Federal drug testing programs. This order exempts certain clinical
toxicology test systems intended for use in Federal drug testing
programs from FDA's 510(k) requirements but does not otherwise affect
Federal drug testing programs, including the management thereof. FDA
believes that the only effect this order will have on Federal drug
testing programs is the possible increase in the number of test systems
that may be utilized in such programs.
(Comment 19) Some commenters urged FDA to finalize the expansion of
the exemptions proposed in the May 2026 notice as soon as possible.
(Response 19) FDA agrees with the commenters that the expansion of
the exemptions proposed in the May 2026 notice should be finalized. The
comment period regarding the expansion of the exemptions proposed in
the May 2026 notice closed on June 30, 2026. FDA has worked to finalize
this order as soon as was practicable following consideration of the
comments submitted on the May 2026 notice.
(Comment 20) One commenter requested that FDA open a docket
regarding how it assigns product codes for ``[F]ederally mandated
workplace drug test system devices.'' This commenter indicated that an
analyte-specific categorization framework may be inconsistent with
modern drug testing systems which generally rely on multi-analyte
platforms.
(Response 20) As explained in FDA's guidance document titled
``Medical Device Classification Product Codes'' (the Product Codes
guidance), ``[c]lassification product codes are a method of internally
classifying and tracking medical devices'' (Ref. 3). The Product Codes
guidance states that product codes are assigned and maintained by the
Agency, and are used to, among other things, ``help to delineate
technology and indication subgroups within a regulation.'' FDA
currently does not intend to open a docket regarding product code
assignment. However, as stated in the Product Codes guidance, ``[a]s
technology changes and 510(k) review practice evolves, some
classification product codes may become obsolete. In some cases,
product code definitions may be updated to accommodate new
technology.'' As technology continues to evolve, FDA may consider
modifications to the product codes assigned to the clinical toxicology
test systems covered in this order.
(Comment 21) Various comments expressed displeasure with the
commenters' personal circumstances connected to failed (or invalid)
drug tests administered as part of a Federal drug testing program and/
or displeasure with how SAMHSA, the NLCP, the DOT, and other non-FDA
organizations administer and/or regulate Federal drug testing programs.
Many of these comments were addressed to entities other than FDA. These
comments did not address the expansion of the exemptions proposed in
the May 2026 notice.
(Response 21) These comments are outside the scope of the May 2026
notice and this order. As discussed in more detail in comment 3, FDA
does not oversee Federal drug testing programs.

IV. Limitations of Exemptions

FDA has determined that premarket notification is not necessary to
assure the safety and effectiveness of the class II clinical toxicology
test systems subject to the limitations outlined in table 1. This
determination 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.

A. General Limitations of Exemptions

The 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). Thus, a manufacturer of a device listed
in this order 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 IV.A of
this notice, partial limitations may limit an exemption from premarket
notification requirements to specific devices within a device type. In
such situations where a partial limitation of the exemption has been
identified, FDA has determined that premarket notification is necessary
to assure the safety and effectiveness for devices that exceed the
limitations.
Prior to issuance of this order, the classification regulations
listed in table 1 already included an exemption from 510(k)
requirements (subject to the general limitations in Sec. 862.9 as
discussed in section IV.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 was not
intended for use in Federal drug testing

[[Page 63484]]

programs.\2\ In this order, FDA is removing the exception to the 510(k)
exemption for devices intended for Federal drug testing programs. As
such, devices in the device types listed in table 1 are 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.
---------------------------------------------------------------------------

\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.
---------------------------------------------------------------------------

When FDA finalized the partial exemptions from 510(k) requirements
that were in effect for the classification regulations listed in table
1 prior to issuance of this order, 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). 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.
---------------------------------------------------------------------------

\3\ For example, prior to issuance of this order, the definition
for product code PUX (Test, Amphetamine, Employment and Insurance
Testing, Exempt) included a reference to 82 FR 31976 (the action
establishing the exemption). Following publication of this order,
this reference, and corresponding ones for the other 510(k)-exempt
product codes, will be replaced with a reference to this order which
codifies the expanded scope of the exemption.
---------------------------------------------------------------------------

V. List of Class II Devices

FDA has determined that premarket notification is not necessary to
assure the safety and effectiveness of clinical toxicology test systems
of the types listed in table 1 when they are intended for Federal drug
testing programs (see ``New Partial Limitations'' listed in table 1).
Devices in the device types listed in table 1 no longer 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 partial limitations of exemptions specified in table 1 and
the corresponding general limitations of exemptions found in Sec.
862.9.

Table 1--Class II Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exempt product Non-exempt product Partial limitations prior to issuance of this
21 CFR section Generic device type code codes order New partial limitations
--------------------------------------------------------------------------------------------------------------------------------------------------------
862.3100.......... Amphetamine test PUX.............. DIT, DJL, DJP, DKZ, Exemption is limited to test systems intended Exemption is limited to
system. DNI, DOD, DPJ, to measure amphetamine for employment and test systems intended
NFT, NVI, OIW. insurance testing and for which the test to measure amphetamine
system labeling includes a statement that for employment and
the device is intended solely for employment insurance testing and
and insurance testing, and does not include for which the test
devices intended for Federal drug testing system labeling
programs. includes a statement
that the device is
intended solely for
employment and
insurance testing.
862.3150.......... Barbiturate test PUY.............. DIS, DJN, DKN, DKX, Exemption is limited to test systems intended Exemption is limited to
system. DLX, DMF, KZY, PTH. to measure barbiturates for employment and test systems intended
insurance testing and for which the test to measure barbiturates
system labeling includes a statement that for employment and
the device is intended solely for employment insurance testing and
and insurance testing, and does not include for which the test
devices intended for Federal drug testing system labeling
programs. includes a statement
that the device is
intended solely for
employment and
insurance testing.
862.3170.......... Benzodiazepine test PUZ.............. JXM, KZZ, LAA, LAB, Exemption is limited to test systems intended Exemption is limited to
system. NFV. to measure any of the benzodiazepine test systems intended
compounds for employment and insurance to measure any of the
testing and for which the test system benzodiazepine
labeling includes a statement that the compounds for
device is intended solely for employment and employment and
insurance testing, and does not include insurance testing and
devices intended for Federal drug testing for which the test
programs. system labeling
includes a statement
that the device is
intended solely for
employment and
insurance testing.
862.3250.......... Cocaine and cocaine PVA.............. DIN, DIO, DIR, DLN, Exemption is limited to test systems intended Exemption is limited to
metabolite test DMN, DNG, DOM, to measure cocaine and a cocaine metabolite test systems intended
system. JXO, KLN, LAC, NFY. (benzoylecgonine) for employment and to measure cocaine and
insurance testing and for which the test a cocaine metabolite
system labeling includes a statement that (benzoylecgonine) for
the device is intended solely for employment employment and
and insurance testing, and does not include insurance testing and
devices intended for Federal drug testing for which the test
programs. system labeling
includes a statement
that the device is
intended solely for
employment and
insurance testing.
862.3270.......... Codeine test system PVB.............. DLD, LAD, LAE...... Exemption is limited to test systems intended Exemption is limited to
to measure codeine for employment and test systems intended
insurance testing and for which the test to measure codeine for
system labeling includes a statement that employment and
the device is intended solely for employment insurance testing and
and insurance testing, and does not include for which the test
devices intended for Federal drug testing system labeling
programs. includes a statement
that the device is
intended solely for
employment and
insurance testing.
862.3580.......... Lysergic acid PVC.............. DLB, DOL........... Exemption is limited to test systems intended Exemption is limited to
diethylamide (LSD) to measure LSD for employment and insurance test systems intended
test system. testing and for which the test system to measure LSD for
labeling includes a statement that the employment and
device is intended solely for employment and insurance testing and
insurance testing, and does not include for which the test
devices intended for Federal drug testing system labeling
programs. includes a statement
that the device is
intended solely for
employment and
insurance testing.

[[Page 63485]]

862.3610.......... Methamphetamine PVD.............. DJC, LAF, LAG, NGG. Exemption is limited to test systems intended Exemption is limited to
test system. to measure methamphetamine for employment test systems intended
and insurance testing and for which the test to measure
system labeling includes a statement that methamphetamine for
the device is intended solely for employment employment and
and insurance testing, and does not include insurance testing and
devices intended for Federal drug testing for which the test
programs. system labeling
includes a statement
that the device is
intended solely for
employment and
insurance testing.
862.3620.......... Methadone test PVE.............. DIW, DJR, DKR, DMB, Exemption is limited to test systems intended Exemption is limited to
system. DNT, DPP, PTG. to measure methadone for employment and test systems intended
insurance testing and for which the test to measure methadone
system labeling includes a statement that for employment and
the device is intended solely for employment insurance testing and
and insurance testing, and does not include for which the test
devices intended for Federal drug testing system labeling
programs. includes a statement
that the device is
intended solely for
employment and
insurance testing.
862.3630.......... Methaqualone test PVF.............. KXS................ Exemption is limited to test systems intended Exemption is limited to
system. to measure methaqualone for employment and test systems intended
insurance testing and for which the test to measure methaqualone
system labeling includes a statement that for employment and
the device is intended solely for employment insurance testing and
and insurance testing, and does not include for which the test
devices intended for Federal drug testing system labeling
programs. includes a statement
that the device is
intended solely for
employment and
insurance testing.
862.3640.......... Morphine test PVG.............. DIQ, DJJ, DLR, DMY, Exemption is limited to test systems intended Exemption is limited to
system. DNA, DNK, DOE, to measure morphine and its analogs for test systems intended
DOK, DPK, NGI. employment and insurance testing and for to measure morphine and
which the test system labeling includes a its analogs for
statement that the device is intended solely employment and
for employment and insurance testing, and insurance testing and
does not include devices intended for for which the test
Federal drug testing programs. system labeling
includes a statement
that the device is
intended solely for
employment and
insurance testing.
862.3650.......... Opiate test system. PVH.............. DJF, DJG, DKT, DLT, Exemption is limited to test systems intended Exemption is limited to
LAH, LAI, NGL. to measure any of the addictive narcotic test systems intended
pain-relieving opiate drugs for employment to measure any of the
and insurance testing and for which the test addictive narcotic pain-
system labeling includes a statement that relieving opiate drugs
the device is intended solely for employment for employment and
and insurance testing, and does not include insurance testing and
devices intended for Federal drug testing for which the test
programs. system labeling
includes a statement
that the device is
intended solely for
employment and
insurance testing.
862.3700.......... Propoxyphene test PVI.............. DPN, JXN, LAJ, LAK, Exemption is limited to test systems intended Exemption is limited to
system. QBF. to measure propoxyphene for employment and test systems intended
insurance testing and for which the test to measure propoxyphene
system labeling includes a statement that for employment and
the device is intended solely for employment insurance testing and
and insurance testing, and does not include for which the test
devices intended for Federal drug testing system labeling
programs. includes a statement
that the device is
intended solely for
employment and
insurance testing.
862.3870.......... Cannabinoid test PVJ.............. DKE, LAT, LDJ, NFW. Exemption is limited to test systems intended Exemption is limited to
system. to measure any of the cannabinoids for test systems intended
employment and insurance testing and for to measure any of the
which the test system labeling includes a cannabinoids for
statement that the device is intended solely employment and
for employment and insurance testing, and insurance testing and
does not include devices intended for for which the test
Federal drug testing programs. system labeling
includes a statement
that the device is
intended solely for
employment and
insurance testing.
862.3910.......... Tricyclic PVK.............. LFG, LFH, LFI, MLK, Exemption is limited to test systems intended Exemption is limited to
antidepressant QAW. to measure any of the tricyclic test systems intended
drugs test system. antidepressant drugs for employment and to measure any of the
insurance testing and for which the test tricyclic
system labeling includes a statement that antidepressant drugs
the device is intended solely for employment for employment and
and insurance testing, and does not include insurance testing and
devices intended for Federal drug testing for which the test
programs. system labeling
includes a statement
that the device is
intended solely for
employment and
insurance testing.
--------------------------------------------------------------------------------------------------------------------------------------------------------

VI. Analysis of Environmental Impact

We have determined under 21 CFR 25.30(h) 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.

VII. Paperwork Reduction Act of 1995

FDA concludes that this final order contains no new collection of
information. This final order refers to previously approved collections
of information. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of
information in part 807, subpart E, regarding premarket notification
submissions, have been approved under OMB control number 0910-0120, the
collections of information in 21 CFR parts 801 and 809, regarding
device labeling, have been approved under OMB control number 0910-0485,
and the collections of information in 21 CFR part 820, regarding
quality management system regulation, have been approved under OMB
control number 0910-0073.

VIII. References

The following references are on display at the Dockets Management

[[Page 63486]]

Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are
available for viewing by interested persons between 9 a.m. and 4 p.m.,
Monday through Friday; they are also available electronically at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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,'' February 19, 1998, available at <a href="https://www.fda.gov/media/72685/download">https://www.fda.gov/media/72685/download</a>.
2. FDA Guidance, ``FDA and Industry Procedures for Section 513(g)
Requests for Information Under the Federal, Food, Drug, and Cosmetic
Act,'' August 23, 2024, available at <a href="https://www.fda.gov/media/78456/download">https://www.fda.gov/media/78456/download</a>.
3. FDA Guidance, ``Medical Device Classification Product Codes,''
April 11, 2013, available at <a href="https://www.fda.gov/media/82781/download">https://www.fda.gov/media/82781/download</a>.

List of Subjects in 21 CFR Part 862

Medical devices.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
862 is amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

0
1. The authority citation for part 862 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. In Sec. 862.3100, revise paragraph (b) to read as follows:

Sec. 862.3100 Amphetamine test system.

* * * * *
(b) Classification. Class II (special controls). An amphetamine
test system is not exempt if it is intended for any use other than
employment or insurance testing. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 862.9, 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.

0
3. In Sec. 862.3150, revise paragraph (b) to read as follows:

Sec. 862.3150 Barbiturate test system.

* * * * *
(b) Classification. Class II (special controls). A barbiturate test
system is not exempt if it is intended for any use other than
employment or insurance testing. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 862.9, 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.

0
4. In Sec. 862.3170, revise paragraph (b) to read as follows:

Sec. 862.3170 Benzodiazepine test system.

* * * * *
(b) Classification. Class II (special controls). A benzodiazepine
test system is not exempt if it is intended for any use other than
employment or insurance testing. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 862.9, 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.

0
5. In Sec. 862.3250, revise paragraph (b) to read as follows:

Sec. 862.3250 Cocaine and cocaine metabolite test system.

* * * * *
(b) Classification. Class II (special controls). A cocaine and
cocaine metabolite test system is not exempt if it is intended for any
use other than employment or insurance testing. The device is exempt
from the premarket notification procedures in subpart E of part 807 of
this chapter subject to the limitations in Sec. 862.9, 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.

0
6. In Sec. 862.3270, revise paragraph (b) to read as follows:

Sec. 862.3270 Codeine test system.

* * * * *
(b) Classification. Class II (special controls). A codeine test
system is not exempt if it is intended for any use other than
employment or insurance testing. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 862.9, 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.

0
7. In Sec. 862.3580, revise paragraph (b) to read as follows:

Sec. 862.3580 Lysergic acid diethylamide (LSD) test system.

* * * * *
(b) Classification. Class II (special controls). A lysergic acid
diethylamide (LSD) test system is not exempt if it is intended for any
use other than employment or insurance testing. The device is exempt
from the premarket notification procedures in subpart E of part 807 of
this chapter subject to the limitations in Sec. 862.9, 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.

0
8. In Sec. 862.3610, revise paragraph (b) to read as follows:

Sec. 862.3610 Methamphetamine test system.

* * * * *
(b) Classification. Class II (special controls). A methamphetamine
test system is not exempt if it is intended for any use other than
employment or insurance testing. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 862.9, 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.

0
9. In Sec. 862.3620, revise paragraph (b) to read as follows:

Sec. 862.3620 Methadone test system.

* * * * *
(b) Classification. Class II (special controls). A methadone test
system is not exempt if it is intended for any use other than
employment or insurance testing. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 862.9, 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.

0
10. In Sec. 862.3630, revise paragraph (b) to read as follows:

Sec. 862.3630 Methaqualone test system.

* * * * *
(b) Classification. Class II (special controls). A methaqualone
test system is not exempt if it is intended for any use other than
employment or insurance testing. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 862.9, provided the test
system is intended for employment and insurance testing and

[[Page 63487]]

includes a statement in the labeling that the device is intended solely
for use in employment and insurance testing.

0
11. In Sec. 862.3640, revise paragraph (b) to read as follows:

Sec. 862.3640 Morphine test system.

* * * * *
(b) Classification. Class II (special controls). A morphine test
system is not exempt if it is intended for any use other than
employment or insurance testing. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 862.9, 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.

0
12. In Sec. 862.3650, revise paragraph (b) to read as follows:

Sec. 862.3650 Opiate test system.

* * * * *
(b) Classification. Class II (special controls). An opiate test
system is not exempt if it is intended for any use other than
employment or insurance testing. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 862.9, 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.

0
13. In Sec. 862.3700, revise paragraph (b) to read as follows:

Sec. 862.3700 Propoxyphene test system.

* * * * *
(b) Classification. Class II (special controls). A propoxyphene
test system is not exempt if it is intended for any use other than
employment or insurance testing. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 862.9, 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.

0
14. In Sec. 862.3870, revise paragraph (b) to read as follows:

Sec. 862.3870 Cannabinoid test system.

* * * * *
(b) Classification. Class II (special controls). A cannabinoid test
system is not exempt if it is intended for any use other than
employment or insurance testing. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 862.9, 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.

0
15. In Sec. 862.3910, revise paragraph (b) to read as follows:

Sec. 862.3910 Tricyclic antidepressant drugs test system.

* * * * *
(b) Classification. Class II (special controls). A tricyclic
antidepressant drugs test system is not exempt if it is intended for
any use other than employment or insurance testing. The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9, 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.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20448 Filed 10-5-26; 8:45 am]
BILLING CODE 4164-01-P

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