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Enhancing CLIA Act of 2026
Introduced May 19, 2026 · Last action May 19, 2026 — Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
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Summary
This legislation is called the Enhancing CLIA Act of 2026. It is being reviewed by a committee.
Full bill text
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8890 Introduced in House (IH)]
<DOC>
119th CONGRESS
2d Session
H. R. 8890
To amend the Public Health Services Act, commonly referred to as the
``Clinical Laboratory Improvement Amendments'' or ``CLIA'', with
respect to laboratory developed tests, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 19, 2026
Mr. Dunn of Florida introduced the following bill; which was referred
to the Committee on Energy and Commerce, and in addition to the
Committee on Ways and Means, for a period to be subsequently determined
by the Speaker, in each case for consideration of such provisions as
fall within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To amend the Public Health Services Act, commonly referred to as the
``Clinical Laboratory Improvement Amendments'' or ``CLIA'', with
respect to laboratory developed tests, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Enhancing Clinical Laboratory
Innovation and Access Act of 2026'' or the ``Enhancing CLIA Act of
2026''.
SEC. 2. ENHANCED REGULATION OF LABORATORY DEVELOPED TESTS.
(a) Amendments to the Public Health Services Act, Commonly Referred
to as the ``Clinical Laboratory Improvement Amendments'' or ``Clia''.--
Section 353 of the Public Health Service Act (42 U.S.C. 263a) is
amended--
(1) by striking subsection (a) and inserting:
``(a) Scope of Authority; Definitions.--
``(1) Scope of authority.--Laboratory operations shall be
regulated by the Secretary under this section and not under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et. seq.).
``(2) Definitions.--In this section:
``(A) Analytical validity.--The term `analytical
validity' means, with respect to an examination or
procedure performed by a laboratory, the ability of the
examination or procedure to provide information that is
accurate and reliable with respect to the
identification, measurement, detection, or calculation
of the target analyte in a specimen, within a
reportable range.
``(B) Applicable standard.--The term `applicable
standard' means--
``(i) for a laboratory developed test for
clinical use, that the test has a reasonable
assurance of analytical and clinical validity;
and
``(ii) for a laboratory developed test for
investigational use, that the test has a
reasonable assurance of analytical validity.
``(C) Clinical use.--The term `clinical use'--
``(i) means that an examination or
procedure is used for the purpose of providing
information for the diagnosis, prognosis,
identification, monitoring, screening,
prevention, or treatment of any disease or
impairment of, or the assessment of the health
of, human beings; and
``(ii) does not include--
``(I) investigational use;
``(II) research use; or
``(III) forensic use.
``(D) Clinical validity.--The term `clinical
validity' means, with respect to an examination or
procedure performed by a laboratory, the ability of the
examination or procedure to provide information that is
accurate and reliable for its stated clinical purpose.
``(E) Digital laboratory data.--The term `digital
laboratory data'--
``(i) means digital data derived from a
laboratory examination or procedure performed
by a laboratory on materials taken or derived
from the human body, including--
``(I) a digital image derived from
a glass slide;
``(II) flow cytometry plots;
``(III) cytogenetic karyograms;
``(IV) chromatographic, mass
spectrometric, clinical chemistry,
immunological, hematological and
microbiological data;
``(V) electropherograms;
``(VI) gel images;
``(VII) genetic expression, array
and sequencing data; and
``(VIII) subsequent analyses of
such data; and
``(ii) is patient-specific when it is
accompanied by information that can be used to
identify the individual from whose specimen the
information was derived.
``(F) Investigational use.--The term
`investigational use' means, with respect to a
laboratory developed test, that the test is used in a
clinical investigation, at least 1 purpose of which is
to gather data to establish the clinical validity of
the test.
``(G) Laboratory; clinical laboratory.--The term
`laboratory' or `clinical laboratory' means a facility
for the examination of materials taken or derived from
the human body, including analysis of patient-specific
digital laboratory data, for clinical use or
investigational use.
``(H) Laboratory developed test.--The term
`laboratory developed test'--
``(i) means an examination or procedure,
including an examination or procedure that
modifies an in vitro diagnostic device
regulated under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.), that is--
``(I) developed in a clinical
laboratory certified under this section
to perform tests of high-complexity;
and
``(II) performed only within--
``(aa) the same clinical
laboratory in which it was
developed; or
``(bb) another clinical
laboratory certified under this
section to perform tests of
high-complexity that is
within--
``(AA) the same
corporate organization
and has common
ownership by the same
parent corporation as
the developing
laboratory; or
``(BB) a public
health laboratory
network coordinated or
managed by the Centers
for Disease Control and
Prevention or other
Federal public health
agency, if the
developing laboratory
is a public health
laboratory or a
laboratory managed by
the Centers for Disease
Control and Prevention
or other Federal public
health agency;
``(ii) does not include a protocol for an
examination or procedure that is commercially
distributed for performance in laboratories not
under common ownership by the same parent
corporation as the laboratory that developed
the protocol;
``(iii) is not a medical device subject to
regulation under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.), even if
the laboratory developed test--
``(I) modifies the use of a device
that is lawfully marketed under the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.);
``(II) requires preparation or
modification within the laboratory of
equipment, reagents, instruments,
software, or other materials for use
within the laboratory;
``(III) includes processes,
materials, research, or intellectual
property developed by third parties if
the developing laboratory remains
responsible for compliance with
applicable requirements for laboratory
developed tests under this section; or
``(IV) examines a specimen that was
self-collected by an individual,
regardless of the setting in which the
specimen was collected; and
``(iv) is performed in a laboratory
described in clause (i)(II) even if software
used in the test is executed outside of the
laboratory.
``(I) Laboratory operations.--The term `laboratory
operations'--
``(i) means the conduct of examinations and
other procedures on material taken or derived
from the human body and associated activities,
including analysis of patient-specific digital
laboratory data, for a purpose described in
subparagraph (E), including the development and
performance of laboratory developed tests; and
``(ii) includes--
``(I) the preparation and transfer
of equipment, reagents, instruments,
software, or other materials between
laboratories that are under common
ownership by the same parent
corporation; and
``(II) the distribution of specimen
collection kits for use with laboratory
developed tests if the components of
such specimen collection kits are
intended to be used consistent with the
established intended uses for which
they may otherwise be lawfully
distributed.
``(J) Performance specifications.--The term
`performance specification' means a value or range of
values for a characteristic of an examination or
procedure, such as accuracy, precision, analytical
sensitivity, analytical specificity, reportable range,
or other characteristic required for test performance.
``(K) Research use.--The term `research use' means,
with respect to a laboratory developed test, that the
test's purpose is solely for analytical development or
scientific research, and not for use in making clinical
decisions for individual patients.'';
(2) by adding at the end:
``(r) Laboratory Developed Tests.--
``(1) Reasonable assurance of analytical and clinical
validity of laboratory developed tests.--
``(A) Standard.--Beginning 2 years after enactment
of the Enhancing CLIA Act of 2026, no laboratory may
perform a laboratory developed test unless the test
meets the applicable standard.
``(B) Analytical validity.--For purposes of meeting
the applicable standard under this section, a
laboratory developed test has a reasonable assurance of
analytical validity if--
``(i) the laboratory that develops the test
establishes performance specifications that
support the ability of the test to identify,
measure, detect, calculate, or analyze 1 or
more analytes, biomarkers, substances, or other
targets intended to be identified, measured,
detected, calculated, or analyzed by the test;
and
``(ii) the laboratory that performs the
test, if different than the laboratory that
develops the test, verifies such performance
specifications prior to use.
``(C) Clinical validity.--For purposes of meeting
the applicable standard under this section, a
laboratory developed test has a reasonable assurance of
clinical validity if the laboratory that develops the
test has documented evidence, which may include 1 or
more of the following that supports the ability of the
laboratory developed test to reliably and accurately
achieve its stated purpose--
``(i) peer-reviewed literature;
``(ii) clinical guidelines;
``(iii) bench studies;
``(iv) case studies or histories;
``(v) consensus standards;
``(vi) reference standards;
``(vii) data registries;
``(viii) postmarket data;
``(ix) real world data;
``(x) 1 or more clinical validation
studies; or
``(xi) other evidence deemed appropriate by
the Secretary.
``(D) Supplemental affirmation that standard has
been met.--
``(i) At any time, a laboratory may, but is
not required to, obtain 1 or more supplemental
affirmations that the laboratory developed test
meets the applicable standard from a third
party approved under subparagraph (E), pursuant
to the process in subparagraph (F). Subject to
clause (ii) of this subparagraph, such
supplemental affirmation does not expire.
``(ii) If a third party approved under
subparagraph (E) has its approval withdrawn by
the Secretary, a supplemental affirmation that
a laboratory developed test meets the
applicable standard issued by that third party
shall remain in effect for no longer than the
later of--
``(I) 90 days after the date that a
third party notifies a laboratory under
subparagraph (E)(iv) that its approval
has been withdrawn; or
``(II) if within 60 days of
receiving the notification under
subparagraph (E)(iv) the laboratory
submits information to a different
third party requesting a supplemental
affirmation that the laboratory
developed test meets the applicable
standard, the date on which such
approved third party determines whether
the laboratory developed test meets the
applicable standard under subparagraph
(F)(i)(II).
``(E) Approved third parties.--Beginning 2 years
after enactment of the Enhancing CLIA Act of 2026, the
Secretary shall approve third parties to provide a
supplemental affirmation that a laboratory developed
test meets the applicable standard if--
``(i) the standards and procedures applied
by the third party in determining whether the
laboratory developed test meets the applicable
standard are determined by the Secretary to be
sufficiently risk-based, rigorous, and not
overly burdensome;
``(ii) in the case that the third party
determines under subparagraph (F)(ii)(III)(cc)
that the data and information provided by the
laboratory demonstrates that the laboratory
developed test does not meet the applicable
standard, the laboratory developed test is
being offered with false or deceptive claims,
or that it is probable that the test will cause
serious adverse health consequences, the third
party agrees to notify the Secretary within 10
days of such determination unless the
laboratory stops offering, and notifies the
third party that it no longer offers, the
laboratory developed test;
``(iii) the third party agrees to notify
the Secretary at least 30 days before it
changes its standards and procedures for
determining that a laboratory developed test
meets the applicable standard; and
``(iv) if the third party has its approval
withdrawn by the Secretary, the third party
agrees to notify each laboratory that obtained
a supplemental affirmation that the applicable
standard was met for any laboratory developed
test of the withdrawal within 10 days of the
withdrawal.
``(F) Process for supplemental affirmation by
approved third party.--
``(i) If a laboratory submits information
to a third party approved by the Secretary
under subparagraph (E) requesting a
supplemental affirmation that a laboratory
developed test meets the applicable standard,
the approved third party shall within 60
calendar days of receipt of the submitted
information--
``(I) review the submitted
information, which may include
communication with the laboratory; and
``(II) determine whether the
laboratory developed test meets the
applicable standard and communicate
such determination with the laboratory
as described in clause (ii).
``(ii) The approved third party shall
provide written notice to the laboratory of the
approved third party's determination under
clause (i)(II) as follows:
``(I) The approved third party
shall notify the laboratory if the
approved third party determines that
the laboratory developed test--
``(aa) meets the applicable
standard; or
``(bb) does not meet the
applicable standard and
subclauses (II) and (III) do
not apply.
``(II) If the approved third party
determines that the laboratory
developed test does not meet the
applicable standard but that such
determination may be resolved within a
reasonable time--
``(aa) the approved third
party shall notify the
laboratory of such
determination and the reasons
therefore, and allow the
laboratory to seek a
teleconference to discuss the
finding;
``(bb) the laboratory shall
submit information
demonstrating resolution of the
determination within 60 days of
receiving such notification;
and
``(cc) the approved third
party shall make a
determination within 30 days of
the receipt of such submission
of information as to whether
the laboratory developed test
continues not to meet the
applicable standard.
``(III) If the approved third party
determines that there is a lack of
credible and verifiable information
supporting that the laboratory
developed test meets the applicable
standard, the laboratory developed test
is being offered with false or
deceptive claims, or that it is
probable that the test will cause
serious adverse health consequences--
``(aa) the approved third
party shall notify the
laboratory of such
determination and the reasons
therefore, and allow the
laboratory to seek a
teleconference to discuss the
finding;
``(bb) the laboratory shall
submit information
demonstrating resolution of the
determination within 60 days of
receiving such notification;
and
``(cc) the approved third
party shall make a
determination within 30 days of
the receipt of such submission
of information as to whether
such determination continues to
apply.
``(iii) In the case that the third party
determines under subparagraph (F)(ii)(I)(bb)
that a laboratory developed test does not meet
the applicable standard, the laboratory may
resubmit a request for supplemental affirmation
by the same or different third party for review
without prejudice at any time.
``(iv) In the case that the third party
determines under subparagraph (F)(ii)(III)(cc)
that there is a lack of credible and verifiable
information supporting the analytical or
clinical validity of the laboratory developed
test, the laboratory developed test is being
offered with false or deceptive claims, or that
it is probable that the test will cause serious
adverse health consequences--
``(I) the third party will not
notify the Secretary of such
determination if the laboratory stops
performing such laboratory developed
test, and notifies the third party that
it has stopped performing such
laboratory test, within 10 days; and
``(II) the laboratory may resubmit
a request for supplemental affirmation
by the same or different third party
for review without prejudice at any
time.
``(G) Deemed supplemental affirmation.--A
laboratory developed test shall be deemed to have
obtained a supplemental affirmation that it meets the
applicable standard under subparagraph (D) if it is--
``(i) approved by the New York State
Department of Health;
``(ii) determined to be reasonable and
necessary under Medicare pursuant to a
favorable review of a technical assessment
under the MolDX Program;
``(iii) within a category of tests
identified by the Secretary in regulation that
shall be deemed to have obtained a supplemental
approval.
``(H) Food and drug administration an approved
third party.--
``(i) The Food and Drug Administration
shall be deemed an approved third party under
subparagraph (E).
``(ii) Beginning 2 years after enactment of
the Enhancing CLIA Act of 2026, a laboratory
may request a supplemental affirmation from the
Food and Drug Administration that a laboratory
developed test for clinical use meets the
applicable standard.
``(iii) Any laboratory seeking supplemental
affirmation from the Food and Drug
Administration under clause (ii) shall pay a
fee for such review that is no greater than the
applicable user fee for a premarket
notification submission under section 738 of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j).
``(iv) If a laboratory seeks supplemental
affirmation from the Food and Drug
Administration under clause (ii) and pays the
fee under clause (iii), the Food and Drug
Administration--
``(I) shall review the information
for the laboratory developed test only
in accordance with the standards
applied by the Secretary under
subparagraph (A) and the procedure
applied by approved third parties under
subparagraph (F); and
``(II) shall not apply to the
laboratory developed test the standards
or other requirements that apply to
devices or any other product regulated
under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.).
``(2) Centralized database for laboratory developed tests
for clinical use.--Beginning 2 years after enactment of the
Enhancing CLIA Act of 2026, each laboratory performing 1 or
more laboratory developed tests for clinical use shall submit
to the Secretary the information described in subparagraph (A)
in accordance with the applicable schedule described in
subparagraph (B). Such information shall be submitted
electronically to the centralized database established by the
Secretary under subparagraph (C). If multiple laboratories
within the same corporate organization and with common
ownership by the same parent corporation perform the same
laboratory developed test, a corporate entity with common
ownership of such laboratories may submit the information
described in subparagraph (A) on behalf of such laboratories,
provided that each laboratory performing a laboratory developed
test is separately identified with respect to each laboratory
developed test it performs.
``(A) Submission.--For each laboratory developed
test performed for clinical use by the laboratory, the
laboratory shall submit the following information, as
applicable:
``(i) Name and certificate number of the
laboratory.
``(ii) Name and certificate number of the
laboratory that developed the laboratory
developed test, if different than the
laboratory performing the laboratory developed
test.
``(iii) Name of the laboratory developed
test.
``(iv) Purpose of the laboratory developed
test, including--
``(I) analyte(s) measured;
``(II) disease(s), impairment(s) or
assessment(s) of the health of human
beings for which the laboratory
developed test is used; and
``(III) for what purpose(s) the
information from the laboratory
developed test will be used, such as
for the screening, diagnosis,
prognosis, or other type of assessment.
``(v) Specimen type(s) used with the
laboratory developed test, which may include
digital laboratory data.
``(vi) Type of examination, such as
biological, microbiological, serological,
chemical, immuno-hematological, hematological,
biophysical, cytological, pathological, flow
cytometric, molecular, genomic, or other type
of examination.
``(vii) Summary of performance
specifications for the laboratory developed
test.
``(viii) Whether the laboratory developed
test modifies the use of a device that is
lawfully marketed under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.) and,
if applicable, information identifying the
specific device that is modified.
``(ix) Whether the test is deemed to have a
supplemental affirmation under regulations
issued by the Secretary or an approved third
party has supplementally affirmed that the
laboratory developed test meets the applicable
standard and, if the latter, the name of such
approved third party.
``(x) If the laboratory developed test is
first performed for clinical use by the
laboratory 2 or more years after enactment of
the Enhancing CLIA Act of 2026, is not deemed
to have a supplemental affirmation under
regulations issued by the Secretary, and an
approved third party has not supplementally
affirmed that the test meets the applicable
standard, a brief summary of the information in
paragraph (1)(B)(c) that supports that the
laboratory developed test has a reasonable
assurance of clinical validity.
``(B) Submission schedule.--
``(i) Tests offered 2 or more years after
enactment of the enhancing clia act of 2026.--
If the laboratory developed test is first
performed for clinical use by the laboratory 2
or more years after the date of enactment of
the Enhancing CLIA Act of 2026, the laboratory
must submit the information in subparagraph (A)
for the laboratory developed test by the later
of--
``(I) 30 days after such laboratory
developed test is first performed for
clinical use; or
``(II) 60 days after the
centralized database described in
subparagraph (C) is established.
``(ii) Tests offered prior to the date that
is 2 years after enactment of the enhancing
clia act of 2026.--If the laboratory developed
test is first performed for clinical use by the
laboratory prior to the date that is 2 years
after enactment of the Enhancing CLIA Act of
2026, the laboratory must submit the
information in subparagraph (A) for the
laboratory developed test by the later of--
``(I) 3 years after enactment of
the Enhancing CLIA Act of 2026; or
``(II) 60 days after the
centralized database described in
subparagraph (C) is established.
``(C) Establishment of centralized database.--Not
later than 2 years after enactment of the Enhancing
CLIA Act of 2026, the Secretary shall make available a
centralized database that is designed to--
``(i) provide a transparent interface on
the website of the Centers for Medicare and
Medicaid Services for stakeholders, to the
extent permitted by applicable laws, which may
include access to--
``(I) information submitted by
laboratories under subparagraph (A);
and
``(II) information about test
errors submitted under paragraph (3);
and
``(ii) provide a secure portal for
electronic submission of information under
subparagraph (A) and reports of test errors
under paragraph (3), which provides protections
from unauthorized disclosure of information,
including of--
``(I) trade secret or confidential
commercial financial information;
``(II) information that could
compromise national security; and
``(III) identifiable patient data.
``(D) Updates and corrections.--
``(i) A laboratory must update or correct
the information submitted under this paragraph
for a laboratory developed test within 30 days
of--
``(I) determining that an update or
correction is necessary to maintain the
accuracy of the previously submitted
information; or
``(II) a request from the Secretary
to make a specific correction, unless
the laboratory demonstrates within 21
days of such request that a correction
is not necessary.
``(ii) A laboratory may supplement or
modify the information submitted under this
paragraph for a laboratory developed test when
new information becomes available.
``(3) Test error reporting.--
``(A) Definitions.--In this section:
``(i) Serious harm.--The term `serious
harm' means a misdiagnosis or failure to
diagnose that results in the absence, delay, or
discontinuation of critical medical treatment,
or administration of unnecessary medical
treatment, that causes death or serious injury
to the patient.
``(ii) Serious injury.--The term `serious
injury' means an injury that--
``(I) is life threatening;
``(II) results in permanent
impairment of a body function or
permanent damage to a body structure;
or
``(III) necessitates further
medical or surgical intervention to
preclude permanent impairment of a body
function or permanent damage to a body
structure.
``(B) Submission of individual reports.--Beginning
2 years after enactment of the Enhancing CLIA Act of
2026, a laboratory shall submit a report not later than
5 calendar days after becoming aware of an undetected
inaccurate result for a laboratory developed test for
clinical use that reasonably suggests--
``(i) that a laboratory developed test
caused serious harm that resulted in death; or
``(ii) an imminent threat to public health.
``(C) Submission of quarterly reports.--Beginning 2
years after enactment of the Enhancing CLIA Act of
2026, a laboratory shall submit quarterly reports that
include any undetected inaccurate results of which the
laboratory becomes aware for laboratory developed tests
for clinical use that reasonably suggest that the
laboratory developed test caused serious harm other
than death. Such quarterly reports shall be submitted
not later than the end of the quarter following the
quarter in which the laboratory becomes aware of such
undetected inaccurate results.
``(D) Report not an admission.--A report submitted
by a laboratory under this paragraph and the
Secretary's release of such report or information does
not constitute an admission by the laboratory that the
laboratory developed test caused or contributed to
serious harm.
``(4) Review of analytical and clinical validity.--
``(A) The criteria described in this subparagraph
are that a laboratory developed test in clinical use--
``(i) does not have a supplemental
affirmation under paragraph (1)(D) that the
applicable standard is met, and the test does
not meet the applicable standard; or
``(ii) has a supplemental affirmation under
subparagraph (1)(D) that the applicable
standard is met, and the test--
``(I) is represented for a purpose
that is not supported by the
supplemental affirmation; and
``(II) does not meet the applicable
standard for such purpose.
``(B) Beginning 2 years after enactment of the
Enhancing CLIA Act of 2026, the Secretary may issue to
the developing laboratory of a laboratory developed
test a written request for information that--
``(i) identifies specific scientific
concerns, based on credible and verifiable
information, which indicate that 1 or more of
the criteria described in subparagraph (A)
apply to the laboratory developed test; and
``(ii) requesting information that would
resolve such concern.
``(C) Not later than 45 days after receiving a
request for information under subparagraph (B)--
``(i) the laboratory--
``(I) may seek a teleconference
prior to the submission of information
under subclause (II) to discuss the
Secretary's request; and
``(II) shall submit the information
requested pursuant to subparagraph (B),
and may include in such submission a
request for a teleconference; and
``(ii) the Secretary shall--
``(I) schedule a teleconference
requested under clause (i)(I); and
``(II) hold a teleconference if
requested within 10 days of the
Secretary's receipt of the information
submitted under clause (i)(II).
``(D) Upon receiving a submission under
subparagraph (C), the Secretary shall--
``(i) review the submitted information
within 45 calendar days of such receipt, which
may include communication with the laboratory;
and
``(ii) determine whether the criteria
listed in subparagraph (A) apply to the
laboratory developed test and communicate such
determination with the laboratory as described
in subparagraph (E).
``(E) The Secretary shall provide written notice to
the laboratory of the Secretary's determination under
subparagraph (D) as follows:
``(i) The Secretary shall notify the
laboratory if the Secretary determines that the
criteria in subparagraph (A)--
``(I) do not apply to the
laboratory developed test; or
``(II) apply to the laboratory
developed test and clause (ii) does not
apply.
``(ii) If the Secretary determines that the
criteria in subparagraph (A) apply to the
laboratory developed test but that such
determination may be resolved within a
reasonable time, and the laboratory developed
test has not previously been subject to this
paragraph on the basis of the same or
substantially similar concerns identified in
the written request issued under subparagraph
(B)--
``(I) the Secretary shall notify
the laboratory of such a determination
and allow the laboratory to seek a
teleconference to discuss the finding;
``(II) the laboratory shall submit
information demonstrating resolution of
the determination within 60 days of
receiving such notification; and
``(III) the Secretary shall make a
determination within 30 days of the
receipt of such submission of
information as to whether the criteria
in subparagraph (A) continue to apply
to the laboratory developed test.
``(F) If the Secretary notifies the laboratory
under subparagraph (E)(i)(II) or (E)(ii)(III) that the
criteria in subparagraph (A) apply to the laboratory
developed test, the laboratory must--
``(i) cease performing the laboratory
developed test until the laboratory obtains a
confirmation from the Secretary under
subparagraph (G) that the criteria under
subparagraph (A) no longer apply to the
laboratory developed test; and
``(ii) instruct all laboratories within the
same corporate organization and under common
ownership by the same parent corporation to
cease performing the laboratory developed test
until the developing laboratory obtains the
confirmation described in clause (i).
``(G) The Secretary shall, within 30 days of
receiving the information described in this
subparagraph, provide a confirmation that the criteria
in subparagraph (A) no longer apply to a laboratory
developed test that was previously issued a
notification under subparagraph (F) if the laboratory
that developed the test submits evidence that--
``(i) it has obtained a supplemental
affirmation from an approved third party under
paragraph (1)(D) that the test meets the
applicable standard; and
``(ii) the criteria in subparagraph (A) no
longer apply to the test.
``(5) Investigational use.--Beginning 2 years after
enactment of the Enhancing CLIA Act of 2026, a laboratory
developed test may not be offered for investigational use
unless it meets the applicable standard for such use and the
test report and all other advertising and promotional materials
for the test clearly state, `For investigational use only'.
Clinical validity has not yet been established.'';
(3) in subsection (e)(2)(A)(ii) by adding at the end
``except that such standards shall not require that laboratory
developed tests offered by the laboratory have a supplemental
affirmation from any approved third party that the applicable
standard has been met,'';
(4) in subsection (i)(1)(C) by inserting ``or (r)'' after
``subsection (d)''; and
(5) in subsection (o) by striking the period and inserting
``, except that the Secretary may not delegate to the Food and
Drug Administration the responsibility or authority for
determining whether any laboratory developed test meets the
applicable standard under subsection (r)(4) of this section.
Notwithstanding the prior sentence, the Food and Drug
Administration may provide a supplemental affirmation that a
laboratory developed test meets the applicable standard
pursuant to subsection (r)(4)(F).''.
(b) Amendments to the Federal Food, Drug, and Cosmetic Act.--The
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is
amended--
(1) in section 201(h)(1) by striking the period after
``pursuant to section 520(o)'' and inserting ``or laboratory
developed tests as defined in the Enhancing CLIA Act of 2026.
For clarity, the term `device' does not include articles
intended solely for medical and scientific research using
materials derived from the body of man or other animals, which
are not intended for any use described in subparagraphs (A)
through (C).''.
(2) in section 501(f)(1)(C) by striking the period at the
end and inserting ``, except that this paragraph does not apply
to a device that is distributed for use with a laboratory
developed test as defined under the Enhancing CLIA Act of 2026
if the device could otherwise be lawfully distributed under
this Act.''.
(3) in section 502(o) by striking the period at the end and
inserting, ``except that this subsection does not apply to a
device that is distributed for use with a laboratory developed
test as defined under the Enhancing CLIA Act of 2026 if the
device could otherwise be lawfully distributed under this
Act.''.
(c) National Coverage Determinations for Laboratory Developed
Tests.--Section 1862(l)(1) of the Social Security Act (42 U.S.C.
1395y(l)(1)) is amended by adding at the end, ``For purposes of all
existing and future national coverage determinations for a clinical
laboratory diagnostic test, a supplemental affirmation from any
approved third party that the applicable standard has been met under
section 353 of the Public Health Services Act (42 U.S.C. 263a et seq.),
as amended by the Enhancing CLIA Act of 2026 shall be considered
equivalent to an approval or clearance under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.).''.
(d) Companion Diagnostics.--If a diagnostic test result is required
for the approval of a drug under section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355) or the licensure of a biologic under
section 351 of the Public Health Service Act (42 U.S.C. 262), such test
result may be determined by use of a device regulated under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or based on a
laboratory developed test with a supplemental affirmation from any
approved third party under section 353 of the Public Health Services
Act (42 U.S.C. 263a et seq.) as amended by this Act.
SEC. 3. TRANSITION.
(a) Effective Date.--Except as otherwise provided in this section,
the amendments made by this Act shall take effect immediately upon
enactment.
(b) Transition and Regulations.--
(1) The Secretary of Health and Human Services (in this
subsection referred to as the ``Secretary'') shall take the
following actions, and may expend such funds as the Secretary
determines necessary to ensure an orderly transition--
(A) within 180 days of enactment, promulgate
proposed regulations required under the amendments made
by this Act;
(B) within 2 years of enactment, establish the
centralized database for laboratory developed tests
under section 353(r)(2) of the Public Health Service
Act, as added by section 2(a) of this Act;
(C) within 2 years of enactment, promulgate final
regulations to mitigate potential conflict of interest
by organizations that provide multiple oversight
services under section 353 of the Public Health
Services Act (42 U.S.C. 263a), including accreditation
of laboratories, proficiency testing, and supplemental
affirmation for laboratory developed tests; and
(D) within 30 days of enactment, revise the
definition of ``in vitro diagnostic products'' at
section 809.3 of Title 21 of the Code of Federal
Regulations, effective immediately, to clarify that
such term--
(i) does not include laboratory developed
tests as defined in subsection (a) of section 2
of this Act; and
(ii) includes protocols for use in the
diagnosis of disease or other conditions,
including a determination of the state of
health, in order to cure, mitigate, treat, or
prevent disease or its sequelae when such
protocols are--
(I) commercially distributed for
performance in laboratories not under
common ownership by the same parent
corporation as the laboratory that
developed the protocol; or
(II) commercially distributed by an
entity or individual that is not a
laboratory;
except that such protocols are not commercially
distributed solely because they are published,
including in public or scientific
presentations, or patented.
(2) Applicability of regulations.--Notwithstanding the date
on which regulations are issued under paragraph (1), no
regulations issued pursuant to the amendments made by this Act
shall be implemented or take effect until 2 years after
enactment, except as otherwise specified in this section.
(c) Conversion.--
(1) This subsection applies to a laboratory developed test
as defined in subsection (a) of section 2 of this Act that
has--
(A) a premarket approval under section 515 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e),
an approved humanitarian device exemption under section
520(m) of such Act (21 U.S.C. 360j(m)), a clearance
under section 510(k) of such Act (21 U.S.C. 360(k)), an
authorization under section 513(f)(2) of such Act (21
U.S.C. 370c(f)(2)), an investigational device exemption
under section 520(g) of such Act (21 U.S.C. 360j(g)),
or a licensure under section 351 of the Public Health
Service Act (42 U.S.C. 262); or
(B) a premarket approval application under section
515 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360e), an application for humanitarian device
exemption under section 520(m) of such Act (21 U.S.C.
360j(m)), a premarket notification under section 510(k)
of such Act (21 U.S.C. 360(k)), a de novo
classification request under section 513(f)(2) of such
Act (21 U.S.C. 370c(f)(2)), an investigational device
exemption under section 520(g) of such Act (21 U.S.C.
360j(g)), or an application for licensure under section
351 of the Public Health Service Act (42 U.S.C. 262)
pending on the date of enactment.
(2) Notwithstanding any other provision of this Act, a
laboratory developed test under paragraph (1) shall be a device
under section 201(h)(1) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(h)(1)) until--
(A) if a notification is submitted under paragraph
(3)(A), the date of such notification; or
(B) if a notification is submitted under paragraph
(3)(B), the earlier of--
(i) approval, clearance, authorization,
exemption, or licensure of a modification to
such test such that it meets the definition of
device under section 201(h)(1) of such Act (21
U.S.C. 321(h)(1));
(ii) 2 years after enactment;
(iii) the date a subsequent notification is
submitted under paragraph (3)(A); or
(iv) 60 days after enactment if no
notification is submitted under paragraph (3).
(3) For a laboratory developed test under paragraph (1),
within 60 days of enactment, a laboratory may submit to the
Food and Drug Administration a notification that the
laboratory--
(A) does not intend to modify the test to meet the
definition of a device under section 201(h)(1) of the
Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)(1)); or
(B) intends to modify the test to meet the
definition of a device under section 201(h)(1) of the
Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)(1)).
(4) For a laboratory developed test under paragraph (1)(A),
upon the applicable date in paragraph (2) that such test is no
longer a device, such test is deemed to have a supplemental
affirmation from the Food and Drug Administration under section
353(r)(1)(D) of the Public Health Service Act (42 U.S.C.
263a(r)(1)(D)), as added by section 2(a) of this Act, that the
laboratory developed test meets the applicable standard.
SEC. 4. CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) UPDATES.
(a) CLIA Specialties.--No later than 180 days after enactment, the
Secretary shall issue a proposed regulation to establish new types of
examinations that may be performed by laboratories under section 353 of
the Public Health Service Act (42 U.S.C. 263a) consistent with the
current state of clinical laboratory science and technology, including
the advancements with respect to molecular diagnostics, digital
pathology, and next generation sequencing. Within 1 year of finalizing
such regulations, the Secretary must evaluate whether additional
proficiency testing programs should be approved for these new
specialties under section 353(f)(3)(C) of such Act (42 U.S.C.
263a(f)(3)(C)).
(b) Notice of Subregulatory Changes.--If the Centers for Medicare
and Medicaid Services intend to issue new or revised sub-regulatory
guidance and policies related to the regulation of laboratories under
section 353 of the Public Health Service Act (42 U.S.C. 263a),
including new or revised State operations manuals applicable to the
regulation of laboratories, it must describe such proposed action in a
public report at least 90 days prior to taking such action and allow an
opportunity for public comment.
(c) Engagement With Laboratories.--The Centers for Medicare and
Medicaid Services must hold regular open door forums with clinical
laboratories, no less frequently than annually, to discuss issues
related to the regulation of laboratories under section 353 of the
Public Health Service Act (42 U.S.C. 263a).
(d) Regulation Updates.--At least once every 5 years, the Centers
for Medicare and Medicaid Services must review the regulations
promulgated under section 353 of the Public Health Service Act (42
U.S.C. 263a), and--
(1) issue a request for information in the Federal Register
regarding whether updates to such regulations are necessary to
reflect advancements in laboratory science and technology; and
(2) establish a public docket, to remain open for no less
than 180 days, to solicit public comments on the request for
information issued under paragraph (1).
<all>Official legislative text sourced from the public record (cached on CivicsHQ).
Official source
View the original bill, actions, and full legislative record on Congress.gov.
Status
In Committee
- 1Introduced
- 2Committee
- 3Floor
- 4Passed
- 5Signed
Timeline reflects current normalized status only. Full action history is not yet stored in the API.
Sponsors
- Rep. Dunn, Neal P. [R-FL-2]RHouseFL
Cosponsors
No cosponsors on record.
Votes
Voting records are not yet available for this bill.