‘‘(G) RISK OF IMMEDIATE HARM.— 
‘‘(i) ORDER.—The Secretary may 
order a laboratory or test-offering entity to 
cease offering or marketing a test with re-
spect to one or more claimed uses if the 
Secretary makes a final determination 
that— 
‘‘(I) the information submitted in 
notifications under paragraph (2) for 
such uses does not demonstrate the 
clinical validity of the claimed uses; 
and 
‘‘(II) the test poses a risk of im-
mediate harm to the public health 
with respect to such claimed uses. 
‘‘(ii) EFFECTIVE UPON RECEIPT.—An 
order under clause (i) shall be effective im-
mediately upon receipt by the laboratory or 
test-offering entity. 
‘‘(iii) CONTENTS.—An order under 
clause (i) shall set forth with specificity the 
reasons for the determinations under each 
of subclauses (I) and (II) of clause (i) and 
shall notify the recipient of the right to ap-
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peal the Secretary’s determinations and 
the procedures for such appeal. 
‘‘(5) ADMINISTRATIVE
APPEAL.—If the Sec-
retary makes a final determination under paragraph 
(4)(A) or (4)(C)(iii) that clinical validity has not 
been established, or issues an order under paragraph 
(4)(G), with respect to one or more clinical uses of 
a test, the laboratory or test-offering entity may, not 
later than 30 days after the date of the final deter-
mination or issuance of the order, bring an adminis-
trative appeal by selecting the procedures set forth 
in one (and only one) of the following subpara-
graphs: 
‘‘(A) DISPUTE RESOLUTION BY ADVISORY 
COMMITTEE.— 
‘‘(i) IN GENERAL.—The laboratory or 
test-offering entity may seek dispute reso-
lution by referral to an advisory committee 
of non-governmental experts who are quali-
fied by training and experience to make a 
recommendation regarding the clinical va-
lidity of the claimed uses of the test. 
‘‘(ii) PROCESS.—In the case of an ap-
peal under this subparagraph, the com-
mittee shall hold a hearing to consider the 
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evidence of clinical validity, shall keep a 
written record of the hearing, and shall 
provide an opportunity for testimony from 
experts presented by both the appellant 
and the Secretary. The committee shall 
make a recommendation to the Secretary 
at the conclusion of the hearing. The Sec-
retary shall consider the record and the 
recommendations of the committee and 
shall make a decision within 90 calendar 
days after the conclusion of the hearing. 
‘‘(iii) 
SELECTION
OF
COMMITTEE 
MEMBERS.—The members of an advisory 
committee under this subparagraph shall 
be selected by the Secretary from among 
individuals, including physicians, with dem-
onstrated expertise in and experience with 
the analytical validity and clinical validity 
of laboratory-developed tests and the lit-
erature related to the validity of such tests. 
‘‘(B) REVIEW
BY
ADMINISTRATIVE
LAW 
JUDGE.—The laboratory or test-offering entity 
may seek review by an administrative law judge 
pursuant to procedures established by the Sec-
retary. 
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‘‘(6) FINAL AGENCY ACTION.— 
‘‘(A) IN GENERAL.—Subject to judicial re-
view under subsection (h), upon final agency ac-
tion under paragraphs (4) and (5) determining 
that clinical validity of one or more claimed 
uses of a test has not been established or upon 
issuance of an order under paragraph (4)(G) 
for one or more claimed uses of a test, the lab-
oratory or test-offering entity shall imme-
diately— 
‘‘(i) cease offering the test for such 
uses; and 
‘‘(ii) cease reporting test results to 
health care providers or individuals for 
such uses. 
‘‘(B) REPORTING
FOR
CERTAIN
SPECI-
MENS.—For specimens that have been received 
or tests that have been ordered but results not 
yet reported, the laboratory or test-offering en-
tity shall notify the person who ordered the test 
that test results will not be reported because 
clinical validity for such clinical uses has not 
been established. 
‘‘(7) 
COMPANION
DIAGNOSTIC
TESTS.—An 
LDT may be authorized under this subsection for a 
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claimed use as a companion diagnostic test for pur-
poses of specifying the use of a drug or biological 
product for therapeutic purposes. An LDT for use 
as a companion diagnostic test shall be reviewed ex-
clusively pursuant to the requirements of this section 
and not under the Federal Food, Drug, and Cos-
metic Act. 
‘‘(d) REGISTRATION
BY
TEST-OFFERING
ENTI-
TIES.— 
‘‘(1) REGISTRATION REQUIREMENT.—A test-of-
fering entity may not offer or market a DTC DNA 
test unless the entity registers with the Secretary in 
accordance with this subsection and maintains such 
registration in effect. 
‘‘(2) TIMING.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), registration by a test-offer-
ing entity under this subsection shall occur be-
fore— 
‘‘(i) the entity offers or markets a 
DTC DNA test; or 
‘‘(ii) submits a premarket notification 
under subsection (c)(2)(A). 
‘‘(B) EXCEPTIONS.— 
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‘‘(i) ENTITIES ALREADY OFFERING OR 
MARKETING TESTS.—In the case of a test- 
offering entity that is offering or mar-
keting a DTC DNA test as of the date on 
which the Secretary establishes interim 
procedures for carrying out this subsection 
under paragraph (4)(B), registration by 
the entity shall occur not later than 60 
days after such date. 
‘‘(ii) 
AUTHORITY
TO
ESTABLISH 
OTHER EXCEPTIONS.—The Secretary may 
establish exceptions to clause (i) in the 
regulations required by paragraph (4)(A). 
‘‘(3) INAPPLICABILITY TO CERTIFIED LABORA-
TORIES.—If a certified laboratory offers a DTC 
DNA test that is not offered or marketed by a test- 
offering entity, such laboratory— 
‘‘(A) is not required to register as a test- 
offering entity under this subsection; and 
‘‘(B) shall not, because of offering such 
test, be regulated as a test-offering entity in-
stead of a laboratory under section 353 or this 
section. 
‘‘(4) REGULATIONS.— 
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‘‘(A) IN GENERAL.—In promulgating regu-
lations under subsection (i)(1), the Secretary 
shall include regulations governing registration 
under this subsection. 
‘‘(B) INTERIM
PROCEDURES.—The Sec-
retary shall establish interim procedures gov-
erning registration under this subsection during 
the period beginning on the date of the enact-
ment of this section and ending on the effective 
date of the regulations required by subpara-
graph (A). The Secretary shall establish such 
interim procedures not later than 90 calendar 
days after the date of the enactment of this sec-
tion. The Secretary may establish such interim 
procedures by a guidance document or other 
means of public notification. 
‘‘(e) INFORMATION REGARDING TEST CAPABILITIES 
AND LIMITATIONS.— 
‘‘(1) INCLUSION OF INFORMATION.—A labora-
tory or test-offering entity that offers an LDT or a 
DTC DNA test shall include in its test result re-
ports, directories of services, marketing materials, 
and advertising— 
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‘‘(A) truthful, accurate, and nondeceptive 
information regarding the capabilities and limi-
tations of the tests; and 
‘‘(B) a statement that the test has been 
validated by the laboratory performing the test 
in accordance with the requirements of the 
Clinical Laboratory Improvement Amendments 
(referred to in this section as ‘CLIA’). 
‘‘(2) CLAIMS NOT IMPUTED TO LABORATORY.— 
A laboratory shall not be subject to a sanction or 
other action under section 353 or this section be-
cause of a claim made by a test-offering entity. 
‘‘(f) REPORTING.— 
‘‘(1) DEATH OR SERIOUS INJURY REPORT.—If 
a laboratory or test-offering entity that offers or 
markets an LDT or DTC DNA test has reason to 
believe that the test may have caused or contributed 
to a death or serious bodily injury— 
‘‘(A) the laboratory or entity shall prompt-
ly investigate the incident; 
‘‘(B) if the laboratory or entity determines 
that the LDT or DTC DNA test may have 
caused or contributed to a death or serious bod-
ily injury, within 10 working days of making 
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such determination the laboratory or entity 
shall report the incident to the Secretary; and 
‘‘(C) the laboratory or entity shall provide 
such additional information regarding the inci-
dent or the test associated with the incident as 
the Secretary may request. 
‘‘(2) COMPLAINT
RECORDS.—A laboratory or 
test-offering entity that offers or markets an LDT 
or DTC DNA test shall maintain a record of— 
‘‘(A) each incident investigated under 
paragraph (1)(A), and each report made under 
paragraph (1)(B), with respect to the test; and 
‘‘(B) for any incident that was determined 
under paragraph (1)(B) not to meet the re-
quirements for reporting to the Secretary, the 
basis for such determination. 
‘‘(3) NO ADMISSION OF CAUSATION.—A report 
submitted under this subsection with respect to an 
event shall not be treated as an admission that the 
test, or the laboratory or its employees, caused or 
contributed to the event. 
‘‘(g) SANCTIONS.— 
‘‘(1) APPLICABILITY OF SANCTIONS TO CLIN-
ICAL LABORATORIES.— 
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‘‘(A) 
INTERMEDIATE
SANCTIONS.—The 
reference in section 353(h)(1) to the ‘require-
ments for the issuance of a certificate’ is 
deemed to include the requirements of this sec-
tion. 
‘‘(B) SUSPENSION, REVOCATION, AND LIM-
ITATION OF CERTIFICATE.— 
‘‘(i) 
The 
reference 
in 
section 
353(i)(1)(A) to ‘misrepresentation in ob-
taining the certificate’ is deemed to include 
any misrepresentation of information in a 
submission to the Secretary pursuant to 
this section. 
‘‘(ii) 
The 
reference 
in 
section 
353(i)(1)(F) to ‘any provisions of this sec-
tion’ is deemed to include any provisions of 
this section. 
‘‘(2) APPLICABILITY OF SANCTIONS TO TEST- 
OFFERING ENTITIES.— 
‘‘(A) INTERMEDIATE SANCTIONS.— 
‘‘(i) IN
GENERAL.—If the Secretary 
determines that a test-offering entity reg-
istered under subsection (d) is no longer 
meeting the requirements of this section, 
the Secretary may impose intermediate 
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sanctions in lieu of the actions authorized 
by subparagraph (B). 
‘‘(ii) TYPES
OF
SANCTIONS; PROCE-
DURES.—The provisions of paragraphs (2) 
and (3) of section 353(h) shall apply with 
respect to intermediate sanctions against a 
test-offering entity under clause (i) to the 
same extent and in the same manner as 
such provisions apply with respect to inter-
mediate sanctions against a laboratory 
under section 353(h). 
‘‘(B) SUSPENSION, REVOCATION, AND LIM-
ITATION
OF
REGISTRATION.—The registration 
of a test-offering entity under subsection (d) 
may be suspended, revoked, or limited if the 
Secretary finds, using the procedures applicable 
under section 353(i)(1) to suspension, revoca-
tion, or limitation of a laboratory’s certificate, 
that the owner or operator or any employee of 
the test-offering entity— 
‘‘(i) has misrepresented information in 
a submission to the Secretary pursuant to 
this section; 
‘‘(ii) has failed to comply with the re-
quirements of this section; 
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‘‘(iii) has failed to comply with rea-
sonable requests of the Secretary for— 
‘‘(I) any information or materials 
that the Secretary concludes are nec-
essary to determine the test-offering 
entity’s continued compliance with the 
requirements of this section; or 
‘‘(II) work on materials, that the 
Secretary concludes is necessary to 
determine the test-offering entity’s 
continued compliance with the re-
quirements of this section; 
‘‘(iv) has refused a reasonable request 
of the Secretary (or, if designated by the 
Secretary, any Federal officer, government 
employee, or a nongovernmental organiza-
tion or an accreditation body designated 
under subsection (k)) for permission to in-
spect the test-offering entity and its oper-
ations and pertinent records during the 
hours the test-offering entity is in oper-
ation; 
‘‘(v) has violated or aided and abetted 
in the violation of any provisions of this 
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