123 
‘‘(B)(i) develops an vitro clinical test or in-
dications for use; or 
‘‘(ii) modifies another developer’s in vitro 
clinical test in that certified laboratory in a 
manner described in section 587(6)(C); and 
‘‘(C) develops an in vitro clinical test or in-
dications for use that are for use only within 
that certified laboratory or within another cer-
tified laboratory with common ownership, 
shall establish and maintain quality requirements 
that comply with the requirements set forth in sub-
section (b)(2). 
‘‘(3) APPLICABILITY
FOR
CERTAIN
IN
VITRO 
CLINICAL TESTS.—The applicable requirements set 
forth in subsection (b)(1) shall apply to any instru-
ment, specimen receptacle, or component or part 
that is developed for use by a clinical laboratory to 
which paragraph (2) applies. 
‘‘(4) REGULATIONS.—In promulgating regula-
tions under this section, the Secretary shall consider 
whether and to what extent international harmoni-
zation is appropriate. 
‘‘(b) QUALITY REQUIREMENTS.— 
‘‘(1) QUALITY
REQUIREMENTS
FOR
LABORA-
TORIES WITHOUT CLIA CERTIFICATION TO CONDUCT 
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HIGH-COMPLEXITY
TESTS.—The quality require-
ments applicable under this section shall— 
‘‘(A) avoid duplication of regulations under 
section 353 of the Public Health Service Act; 
‘‘(B) apply only to the development, valida-
tion, production, preparation, propagation, or 
assembly related to the design and associated 
manufacture and distribution of an in vitro clin-
ical test offered under this subchapter; 
‘‘(C) not apply with respect to laboratory 
operations; and 
‘‘(D) shall include the following, subject to 
paragraphs (2) and (3)— 
‘‘(i) management responsibility; 
‘‘(ii) quality audits; 
‘‘(iii) personnel; 
‘‘(iv) design controls; 
‘‘(v) document controls; 
‘‘(vi) purchasing controls; 
‘‘(vii) identification and traceability; 
‘‘(viii) production and process con-
trols; 
‘‘(ix) acceptance activities; 
‘‘(x) nonconforming product; 
‘‘(xi) corrective and preventive action; 
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125 
‘‘(xii) labeling and packaging controls; 
‘‘(xiii) handling, storage, distribution, 
and installation; 
‘‘(xiv) records; 
‘‘(xv) servicing; and 
‘‘(xvi) statistical techniques. 
‘‘(2) QUALITY
REQUIREMENTS
FOR
LABORA-
TORIES CERTIFIED TO CONDUCT HIGH-COMPLEXITY 
TESTS.—Quality requirements applicable to the in 
vitro clinical tests and developers described in sub-
section (a)(2) shall— 
‘‘(A) avoid duplication of regulations under 
section 353 of the Public Health Service Act; 
and 
‘‘(B) consist of, as directed related to the 
design and development— 
‘‘(i) design controls; 
‘‘(ii) purchasing controls; 
‘‘(iii) acceptance activities; 
‘‘(iv) corrective and preventative ac-
tion; and 
‘‘(v) records. 
‘‘(3) QUALITY
REQUIREMENTS
FOR
CERTAIN 
LABORATORIES
DISTRIBUTING
IN
VITRO
CLINICAL 
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126 
TESTS OR TEST PROTOCOLS WITHIN ORGANIZATIONS 
OR PUBLIC HEALTH NETWORKS.— 
‘‘(A) IN GENERAL.—Quality requirements 
applicable to the developer who is distributing 
in vitro clinical test distributed as described in 
subparagraph (B) shall consist of the following: 
‘‘(i) The requirements in paragraph 
(2). 
‘‘(ii) The labeling requirements in 
paragraph (1)(C)(xii). 
‘‘(iii) The requirement to maintain 
records of the laboratories to which the in 
vitro clinical test or test protocol is distrib-
uted. 
‘‘(B) DISTRIBUTING
LABORATORY.—Sub-
paragraph (A) shall apply to developers that 
meet the following conditions: 
‘‘(i) The laboratory distributing the 
test protocol is certified by the Secretary 
under section 353 of the Public Health 
Service Act and meets the requirements for 
performing high-complexity testing. 
‘‘(ii) The laboratory develops its own 
in vitro clinical test or modifies another de-
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127 
veloper’s in vitro clinical test in a manner 
described in section 587(6)(C). 
‘‘(iii) The laboratory distributes the in 
vitro clinical test or test protocol for such 
test only to another laboratory that— 
‘‘(I) is certified by the Secretary 
under section 353 of the Public 
Health Service Act and meets the re-
quirements for performing high-com-
plexity testing; 
‘‘(II) is within the same cor-
porate organization and having com-
mon ownership by the same parent 
corporation; or as applicable, is a lab-
oratory within a public health labora-
tory network coordinated or managed 
by the Centers for Disease Control 
and Prevention; and 
‘‘(III) implements the test pro-
tocol without further modification. 
‘‘(c) REGULATIONS.—In implementing quality re-
quirements for test developers under this section, the Sec-
retary shall— 
‘‘(1) for purposes of facilitating international 
harmonization, consider whether the developer par-
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128 
ticipates in an audit program in which the United 
States participates or the United States recognizes 
or conforms with standards recognized by the Sec-
retary; and 
‘‘(2) ensure a least burdensome approach de-
scribed in section 587B(j) by leveraging, to the ex-
tent applicable, the quality assurance requirements 
applicable to developers certified by the Secretary 
under section 353 of the Public Health Service Act. 
‘‘SEC. 587K. LABELING REQUIREMENTS. 
‘‘(a) IN GENERAL.—An in vitro clinical test shall 
bear or be accompanied by labeling, and a label as applica-
ble, that meet the requirements set forth in subsections 
(b) and (c), unless such test is exempt as specified in sub-
section (d) or (e). 
‘‘(b) LABELS.— 
‘‘(1) IN GENERAL.—The label of an in vitro 
clinical test shall meet the requirements set forth in 
paragraph (2), except this requirement shall not 
apply to an in vitro clinical test that— 
‘‘(A) consists solely of a test protocol; or 
‘‘(B) is developed, manufactured, and used 
solely within a single laboratory certified by the 
Secretary under section 353 of the Public 
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129 
Health Service Act that meets the requirements 
for performing high-complexity testing. 
‘‘(2) REGULATIONS.—The label of an in vitro 
clinical test shall state the name and place of busi-
ness of its developer and meet the requirements set 
forth in regulations promulgated under this section. 
‘‘(c) LABELING.— 
‘‘(1) IN GENERAL.—Labeling accompanying an 
in vitro clinical test, including labeling in the form 
of a package insert, standalone laboratory reference 
document, or other similar document except the la-
beling specified in paragraph (2), shall include ade-
quate directions for use and shall meet the require-
ments set forth in regulations promulgated under 
this section, except as provided in subsection (d) or 
(e). 
‘‘(2) CONTENT.— 
‘‘(A) 
IN
GENERAL.—Labeling 
accom-
panying an in vitro clinical test that is in the 
form of a test report template or ordering infor-
mation shall include— 
‘‘(i) the test listing number that was 
provided to the developer at the time of 
listing; 
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130 
‘‘(ii) instructions for how and where 
to report an adverse event under section 
587L; 
‘‘(iii) instructions for how and where 
to access the performance summary data 
displayed in the listing database for the 
test; 
‘‘(iv) the intended use of the in vitro 
clinical test; and 
‘‘(v) any warnings, contraindications, 
or limitations. 
‘‘(B) PUBLIC AVAILABILITY OF INFORMA-
TION.—The Secretary shall make all of the in-
formation described in subparagraph (A) with 
respect to each in vitro clinical test available to 
the public, as applicable, in accordance with 
section 587T, except to the extent that the Sec-
retary determines that such information is— 
‘‘(i) trade secret or commercial con-
fidential information; or 
‘‘(ii) national security or counter-
measures or is restricted from disclosure 
pursuant to another provision of law. 
‘‘(3) ADDITIONAL
REQUIREMENTS.—Labeling 
for 
an 
in 
vitro 
clinical 
test 
used 
for 
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131 
immunohematology testing shall meet the applicable 
requirements set forth in part 660 of title 21, Code 
of Federal Regulations (or any successor regula-
tions), related to the labeling of blood grouping re-
agents, reagent red blood cells, and anti-human 
globulin. 
‘‘(d) EXEMPTIONS
AND ALTERNATIVE REQUIRE-
MENTS.— 
‘‘(1) IN GENERAL.— 
‘‘(A) IN GENERAL.—With respect to an in 
vitro clinical test that meets the criteria of sub-
paragraph (B), the ‘state in one place’ regula-
tions under section 809.10(b) of title 21 of the 
Code of Federal Regulations (or any successor 
regulations) may be satisfied by the laboratory 
posting such information on its website or in 
multiple documents, if such documents are 
maintained and accessible in one place. 
‘‘(B) APPLICABLE
TESTS.—An in vitro 
clinical test meets the criteria of this subpara-
graph if such test is— 
‘‘(i) designed and manufactured by a 
laboratory certified by the Secretary under 
section 353 of the Public Health Service 
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132 
Act that meets the requirements for per-
forming high-complexity testing; and 
‘‘(ii) performed in the same laboratory 
in which it was developed or by another 
such laboratory certified by the Secretary 
under section 353 of the Public Health 
Service Act that meets the requirements 
for performing high complexity testing and 
is under common ownership with the lab-
oratory that designed and manufactured 
the test. 
‘‘(2) TEST INSTRUMENT LABELING.—The label-
ing for an instrument is not required to bear the in-
formation indicated in paragraphs (3), (4), (5), (7), 
(8), (9), (10), (11), (12), and (13) of section 
809.10(b) of title 21 of the Code of Federal Regula-
tions (or any successor regulations). 
‘‘(3) REAGENT
LABELING.—For purposes of 
compliance with subsection (c)(1), the labeling for a 
reagent intended for use as a replacement in an in 
vitro clinical test may be limited to that information 
necessary to identify the reagent adequately and to 
describe its proper use in the system. 
‘‘(4) LAB
RESEARCH
OR
INVESTIGATIONAL 
USE.—A shipment or other delivery of an in vitro 
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133 
clinical test for research or investigational use pur-
suant to section 587A(m) shall be exempt from the 
labeling requirements of subsections (b) and (c)(1) 
and from any standard promulgated through regula-
tions, except as required under section 353 of the 
Public Health Service Act or section 587R of this 
Act. 
‘‘(5) GENERAL
PURPOSE
LABORATORY
RE-
AGENTS.—The labeling of general purpose labora-
tory reagents (such as hydrochloric acid) whose uses 
are generally known by persons trained in their use 
need not bear the directions for use required by sub-
sections (b) and (c)(1). 
‘‘(6) ANALYTE SPECIFIC REAGENTS.—The la-
beling for analyte specific reagents shall bear the fol-
lowing statement: ‘This product is intended solely 
for further development of an in vitro clinical test 
and is exempt from most FDA regulation. This 
product must be evaluated by the in vitro clinical 
test developer in accordance with applicable require-
ments.’. If the labeling of an analyte specific reagent 
bears the statement set forth in this paragraph, it 
need not bear the information required by subsection 
(c)(1). 
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134 
‘‘(7) OVER-THE-COUNTER TEST SAMPLE COL-
LECTION
SYSTEMS
LABELING.—The labeling for 
over-the-counter test sample collection systems for 
drugs of abuse testing shall bear the name and place 
of business of the developer included in the registra-
tion listing under section 587I, in language appro-
priate for the intended users. 
‘‘(e) TESTS IN THE STRATEGIC NATIONAL STOCK-
PILE.— 
‘‘(1) IN GENERAL.—The Secretary may grant 
an exception or alternative to any provision listed in 
this section, unless explicitly required by a statutory 
provision outside this subchapter, for specified lots, 
batches, or other units of an in vitro clinical test, if 
the Secretary determines that compliance with such 
labeling requirement could adversely affect the safe-
ty, effectiveness, or availability of such products that 
are or will be included in the Strategic National 
Stockpile under section 319F–2 of the Public Health 
Service Act. 
‘‘(2) REGULATIONS.—The Secretary may issue 
regulations amending section 809.11 of title 21 of 
the Code of Federal Regulations or any successor 
regulation to apply in full or in part to in vitro clin-
ical tests and in vitro clinical test developers. 
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135 
‘‘(f) GUIDANCE.—The Secretary may, in collabora-
tion with developers, issue guidance on standardized, gen-
eral content and format for in vitro clinical test labeling 
to help ensure compliance with applicable requirements in 
this subsection. 
‘‘SEC. 587L. ADVERSE EVENT REPORTING. 
‘‘(a) APPLICABILITY.— 
‘‘(1) IN GENERAL.—Each in vitro clinical test 
developer shall establish and maintain a system for 
reporting adverse events in accordance with sub-
section (b), except as provided in section 587A. 
‘‘(2) REGULATIONS.—The Secretary shall pro-
mulgate regulations to implement this section, in-
cluding information necessary to be reported to en-
sure the analytical and clinical validity of in vitro 
clinical tests, and the safety of articles for taking or 
deriving specimens from the human body. 
‘‘(b) 
ADVERSE
EVENT
REPORTING
REQUIRE-
MENTS.—Each developer shall report to the Secretary 
whenever information that reasonably suggests that one 
of the developer’s in vitro clinical tests is associated with 
an adverse event becomes known to the developer. 
‘‘(c) REPORTS.—Reports required under this section 
shall be submitted as follows: 
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‘‘(1) An individual adverse event report shall be 
submitted for the following events not later than— 
‘‘(A) 5 calendar days after an in vitro clin-
ical test developer receives or otherwise becomes 
aware of information that reasonably suggests 
the adverse event involves a patient death; or 
‘‘(B) 5 calendar days after an in vitro clin-
ical test developer receives or otherwise becomes 
aware of information that reasonably suggests 
the event presents an imminent threat to public 
health. 
‘‘(2) Quarterly reports shall be submitted for all 
other adverse events, if any, and no later than the 
end of the quarter following the quarter in which the 
adverse event information was received by the in 
vitro clinical test developer. 
‘‘(d) DEFINITIONS.—In this section— 
‘‘(1) the term ‘adverse event’— 
‘‘(A) means— 
‘‘(i) death of, or serious injury to, a 
specific patient or user for which it is rea-
sonably believed that an in vitro clinical 
test error contributed to such death or se-
rious injury; or 
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137 
‘‘(ii) an in vitro clinical test error that 
may have reasonable likelihood to cause se-
rious injury or death; and 
‘‘(B) excludes laboratory errors that are 
subject to the requirements of section 353 of 
the Public Health Service Act and corrective or 
preventive actions to prevent such errors; 
‘‘(2) the term ‘in vitro clinical test error’— 
‘‘(A) means a failure in an in vitro clinical 
test to meet the analytical or clinical validity 
standard or otherwise perform as intended by 
the developer; and 
‘‘(B) includes an inaccurate false result 
that reaches a health care provider, patient, or 
consumer, except that such term excludes any 
such event or error related to laboratory oper-
ations pursuant to section 353 of the Public 
Health Service Act; and 
‘‘(3) the term ‘serious injury’ means— 
‘‘(A) a significant delay in a critical diag-
nosis or causing the absence, delay, or dis-
continuation of critical medical treatment or 
that irreversibly or seriously and negatively al-
ters the course of the disease or condition; or 
‘‘(B) an injury that— 
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138 
‘‘(i) is life threatening; 
‘‘(ii) results in permanent impairment 
of a body function or permanent damage 
to a body structure; or 
‘‘(iii) necessitates medical or surgical 
intervention to preclude permanent impair-
ment of a body function or permanent 
damage to a body structure. 
‘‘SEC. 587M. CORRECTIONS AND REMOVALS. 
‘‘(a) IN GENERAL.—The Secretary shall promulgate 
regulations to implement this section, including informa-
tion necessary to be reported to ensure the analytical and 
clinical validity of in vitro clinical tests, and the safety of 
specimen receptacles. 
‘‘(b) REPORTS OF REMOVALS AND CORRECTIONS.— 
‘‘(1) IN GENERAL.—Each in vitro clinical test 
developer or importer shall report to the Secretary 
any correction or removal of an in vitro clinical test 
undertaken by such developer or importer if the re-
moval or correction was undertaken— 
‘‘(A) to reduce the risk to health posed by 
the in vitro clinical test; or 
‘‘(B) to remedy a violation of this Act 
caused by the in vitro clinical test which may 
present a risk to health. 
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139 
‘‘(2) EXCEPTION.—No report of the correction 
or removal of an in vitro clinical test is required 
under paragraph (1) if a report of the correction or 
removal is required under, and has been submitted 
under, section 587L. 
‘‘(c) TIMING.—A developer or importer shall submit 
any report required under this subsection to the Secretary 
within 15 business days of initiating such correction or 
removal. 
‘‘(d) RECORDKEEPING.—A developer or importer of 
an in vitro clinical test who undertakes a correction or re-
moval of an in vitro clinical test which is not required to 
be reported under this subsection shall keep a record of 
such correction or removal. 
‘‘(e) RECALL
COMMUNICATIONS.—Upon the vol-
untary reporting of a correction or removal by the devel-
oper— 
‘‘(1) the Secretary shall classify such correction 
or removal under this section within 15 calendar 
days; and 
‘‘(2) not later than 45 calendar days after the 
developer or other responsible party notifies the Sec-
retary that it has completed a recall action, the Sec-
retary shall provide the developer or other respon-
sible party with a written statement closing the re-
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140 
call action or stating the reasons the Secretary can-
not close the recall at that time. 
‘‘(f) LIMITATION.—The developer is not required to 
report a correction or removal of an in vitro clinical test 
based solely on an adverse event report under section 
587L that captures an error within the approved perform-
ance standards for such test. 
‘‘(g) DEFINITIONS.—For purposes of this section— 
‘‘(1) the term ‘correction’ means the repair, 
modification, adjustment, relabeling, destruction, or 
inspection (including patient monitoring) of an in 
vitro clinical test without its physical removal from 
its point of use to another location, and does not in-
clude routine servicing; and 
‘‘(2) the term ‘removal’ means the physical re-
moval of an in vitro clinical test from its point of use 
to another location for repair, modification, adjust-
ment, relabeling, destruction, or inspection, and does 
not include routine servicing. 
‘‘SEC. 587N. RESTRICTED IN VITRO CLINICAL TESTS. 
‘‘(a) APPLICABILITY.— 
‘‘(1) IN GENERAL.—The Secretary, in issuing 
an approval of an in vitro clinical test under section 
587B of a category described in paragraph (3) may 
require that such test be restricted to sale, distribu-
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141 
tion, or use upon such conditions as the Secretary 
may prescribe under paragraph (2). 
‘‘(2) CONDITIONS
PRESCRIBED
BY
THE
SEC-
RETARY.—The conditions prescribed by the Sec-
retary under this paragraph, with respect to an in 
vitro clinical test described in paragraph (3), are 
those conditions which the Secretary determines due 
to the potentiality for harmful effect of such test (in-
cluding any resulting absence, delay, or discontinu-
ation of appropriate medical treatment), are nec-
essary to assure the analytical or clinical validity of 
the test, or the safety of a specimen receptacle. 
‘‘(3) IN VITRO CLINICAL TESTS SUBJECT TO 
RESTRICTIONS.—The restrictions authorized under 
this section may be applied by the Secretary to any 
high-risk in vitro clinical test, prescription home-use 
in vitro clinical test, direct-to-consumer in vitro clin-
ical test, or over-the-counter in vitro clinical test. 
‘‘(b) LABELING AND ADVERTISING OF A RESTRICTED 
IN VITRO CLINICAL TEST.—The label, labeling, and ad-
vertising of an in vitro clinical test to which restrictions 
apply under subsection (a) shall bear such appropriate 
statements of the restrictions as the Secretary may pre-
scribe in the approval, provisional approval, technology 
certification, or regulation, as applicable. 
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142 
‘‘(c) REQUIREMENTS PRIOR TO ENACTMENT.—An in 
vitro clinical test that was offered, sold, or distributed as 
a restricted device prior to the enactment date of this sub-
chapter shall continue to comply with the applicable re-
strictions under section 515 or section 520(e) until the 
effective date of restrictions issued under subsection (a). 
‘‘SEC. 587O. APPEALS. 
‘‘(a) SIGNIFICANT DECISION.— 
‘‘(1) IN GENERAL.—The Secretary shall provide 
a substantive summary of the scientific and regu-
latory rationale for any significant decision of the 
Center for Devices and Radiological Health regard-
ing submission of an application for, or a review of, 
an in vitro clinical test under section 587B or sec-
tion 587D or regarding an exemption under section 
587A, including documentation of significant con-
troversies or differences of opinion and the resolu-
tion of such controversies or differences of opinion. 
‘‘(2) PROVISION
OF
DOCUMENTATION.—Upon 
request, the Secretary shall furnish a substantive 
summary described in paragraph (1) to the person 
who has made, or is seeking to make, a submission 
described in such paragraph. 
‘‘(3) APPLICATION OF LEAST BURDENSOME RE-
QUIREMENTS.—The substantive summary required 
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143 
under this subsection shall include a brief statement 
regarding how the least burdensome requirements 
were considered and applied consistent with section 
587B(j), as applicable. 
‘‘(b) REVIEW OF SIGNIFICANT DECISIONS.— 
‘‘(1) REQUEST FOR SUPERVISORY REVIEW OF 
SIGNIFICANT DECISION.—Any person may request a 
supervisory review of the significant decision de-
scribed in subsection (a)(1). Such review may be 
conducted at the next supervisory level or higher 
above the agency official who made the significant 
decision. 
‘‘(2) SUBMISSION OF REQUEST.—A person re-
questing a supervisory review under paragraph (1) 
shall submit such request to the Secretary not later 
than 30 days after the decision for which the review 
is requested and shall indicate in the request wheth-
er such person seeks an in-person meeting or a tele-
conference review. 
‘‘(3) TIMEFRAME.—The Secretary shall sched-
ule an in-person or teleconference review, if so re-
quested, not later than 30 days after such request 
is made. The Secretary shall issue a decision to the 
person requesting a review under this subsection not 
later than 45 days after the request is made under 
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144 
paragraph (1), or, in the case of a person who re-
quests an in-person meeting or teleconference, 30 
days after such meeting or teleconference. 
‘‘(c) ADVISORY PANELS.—The process established 
under subsection (a) shall permit the appellant to request 
review by an advisory committee established under section 
513 or 587G. The Secretary shall provide a response to 
an appellant under this subsection not later than 45 days 
after the requested advisory committee is convened. 
‘‘SEC. 587P. ACCREDITED PERSONS. 
‘‘(a) IN GENERAL.— 
‘‘(1) REVIEW OF APPLICATIONS.— 
‘‘(A) ACCREDITATION
FOR
APPLICATION 
REVIEW.—Subject to subparagraph (C), during 
the period beginning on the date of enactment 
of the Verifying Accurate Leading-edge IVCT 
Development Act of 2021 and ending 2 years 
after the date of enactment of such Act, the 
Secretary shall accredit persons for any of the 
following purposes: 
‘‘(i) Reviewing applications for pre-
market approval under section 587B and 
applications for technology certification 
under section 587D. 
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‘‘(ii) Making recommendations to the 
Secretary with respect to an approval of an 
application under section 587B or issuance 
of a technology certification order under 
section 587D. 
‘‘(B) REQUIREMENT
REGARDING
REVIEW 
RECOMMENDATIONS.— 
‘‘(i) IN GENERAL.—In making a rec-
ommendation to the Secretary under this 
section, an accredited person shall notify 
the Secretary in writing of the reasons for 
the recommendation concerning the appli-
cation. 
‘‘(ii) TIME
PERIOD
FOR
REVIEW.— 
Not later than 30 calendar days after the 
date on which the Secretary is notified of 
a recommendation under this section with 
respect to an application for premarket ap-
proval or technology certification, the Sec-
retary shall make a determination with re-
spect to the application. 
‘‘(C) LACK OF APPLICATIONS WITHIN 2- 
YEAR TIMEFRAME.—If the Secretary does not 
receive applications from persons that meet the 
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criteria under subsection (c) within such period, 
the Secretary— 
‘‘(i) may accredit persons under this 
paragraph after the 2-year period de-
scribed in subparagraph (A); and 
‘‘(ii) shall issue a public notice on the 
website of the Food and Drug Administra-
tion calling for applications for such ac-
creditation. 
‘‘(2) INSPECTIONS.— 
‘‘(A) ACCREDITATION FOR INSPECTIONS.— 
Subject to subparagraph (B), during the period 
beginning on the date of enactment of the 
Verifying Accurate Leading-edge IVCT Devel-
opment Act of 2021 and ending 2 years after 
the date of enactment of such Act, the Sec-
retary shall accredit persons for the purpose of 
conducting inspections of in vitro clinical test 
developers and other persons required to reg-
ister pursuant to section 587I. 
‘‘(B) LACK OF APPLICATIONS WITHIN 2- 
YEAR TIMEFRAME.—If no persons who meet the 
criteria for such accreditation apply during the 
2-year period described in subparagraph (A), 
the Secretary— 
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‘‘(i) may accredit persons under this 
subparagraph after such period; and 
‘‘(ii) shall issue a public notice on the 
website of the Food and Drug Administra-
tion calling for applications for such ac-
creditation. 
‘‘(C) EFFECT OF ACCREDITATION.— 
‘‘(i) IN GENERAL.—Persons accredited 
under subparagraph (A) to conduct inspec-
tions, when conducting such inspections, 
shall record in writing their specific obser-
vations and shall present their observations 
to the designated representative of the in-
spected establishment. 
‘‘(ii) INSPECTION
REPORT
REQUIRE-
MENTS.—Each person accredited under 
this paragraph shall prepare and submit to 
the Secretary an inspection report in a 
form and manner designated by the Sec-
retary for conducting inspections, taking 
into consideration the goals of inter-
national harmonization of quality systems 
standards. Any official classification of the 
inspection shall be determined by the Sec-
retary. Any statement or representation 
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made by an employee or agent of an estab-
lishment to a person accredited to conduct 
inspections shall be subject to section 1001 
of title 18, United States Code. 
‘‘(D) SAVINGS CLAUSE.—Nothing in this 
section affects the authority of the Secretary to 
inspect any in vitro clinical test developer or 
other person registered under section 587I. 
‘‘(E) INSPECTION LIMITATIONS.—The Sec-
retary shall ensure that inspections carried out 
under this section are not duplicative of inspec-
tions carried out under section 353 of the Pub-
lic Health Service Act. Inspections under this 
section shall be limited to the data and informa-
tion necessary— 
‘‘(i) for routine surveillance activities 
associated with applications under sections 
587B and 587D; or 
‘‘(ii) to meet the requirements to re-
ceive premarket approval under section 
587B or a technology certification order 
under section 587D, as applicable. 
‘‘(b) ACCREDITATION.— 
‘‘(1) ACCREDITATION PROGRAM.— 
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‘‘(A) IN
GENERAL.—The Secretary may 
provide for accreditation under this section 
through programs administered by the Food 
and Drug Administration, by other non-Federal 
government agencies, or by qualified nongovern-
mental organizations. A person may be accred-
ited for the review of both applications sub-
mitted under sections 587B and 587D as de-
scribed in subsection (a)(1)(A) and to conduct 
inspection activities under subsection (a)(2)(A), 
or for a subset of such review or activities. 
‘‘(B) ELIGIBLE PERSONS.—Not later than 
180 days after the date of enactment of the 
Verifying Accurate Leading-edge IVCT Devel-
opment Act of 2021, the Secretary shall issue 
draft guidance on the criteria that the Sec-
retary will use to accredit or deny accreditation 
to a person who requests such accreditation 
under subsection (a), and not later than one 
year after the close of the comment period for 
the draft guidance issued in this section, issue 
final guidance. 
‘‘(C) REQUIREMENTS.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall not accredit or maintain accreditation 
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for a person unless such person meets the 
minimum qualifications required under 
subsection (c). 
‘‘(ii) SCOPE
OF
ACCREDITATION.— 
The accreditation of a person under this 
section shall specify the particular activi-
ties under subsection (a) for which such 
person is accredited. 
‘‘(D) PUBLIC LIST.—The Secretary shall 
publish on the website of the Food and Drug 
Administration a list of persons who are accred-
ited under this section. Such list shall be up-
dated on at least a monthly basis. The list shall 
specify the particular activity or activities under 
this section for which the person is accredited. 
‘‘(2) ACCREDITATION PROCESS.— 
‘‘(A) 
ACCREDITATION
PROCESS
GUID-
ANCE.—The Secretary shall— 
‘‘(i) not later than 180 days after the 
date of enactment of the Verifying Accu-
rate Leading-edge IVCT Development Act 
of 2021, issue draft guidance specifying 
the process for submitting a request for 
each type of accreditation and reaccredita-
tion under this section, including the form 
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and content of information to be submitted 
in such a request; and 
‘‘(ii) not later than 1 year after the 
close of the comment period for the draft 
guidance, issue final guidance. 
‘‘(B) RESPONSE TO REQUEST.—The Sec-
retary shall respond to a request for accredita-
tion or reaccreditation within 60 calendar days 
of the receipt of the request. The Secretary’s 
response may be to accredit or reaccredit the 
person, to deny accreditation, or to request ad-
ditional information in support of the request. 
If the Secretary requests additional informa-
tion, the Secretary shall respond within 60 cal-
endar days of receipt of such additional infor-
mation to accredit or deny the accreditation. 
‘‘(C) TYPE OF ACCREDITATION.—The ac-
creditation or reaccreditation of a person shall 
specify the particular activity or activities under 
subsection (a) for which such person is accred-
ited, and shall include any limitation to certain 
eligible in vitro clinical tests. 
‘‘(D) AUDIT.—The Secretary may audit 
the performance of persons accredited under 
this section for purposes of ensuring that such 
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persons continue to meet the published criteria 
for accreditation, and may modify the scope or 
particular activities for which a person is ac-
credited if the Secretary determines that such 
person fails to meet one or more criteria for ac-
creditation. 
‘‘(E) SUSPENSION OR WITHDRAWAL.—The 
Secretary may suspend or withdraw accredita-
tion of any person accredited under this section, 
after providing notice and an opportunity for an 
informal hearing, when such person is substan-
tially not in compliance with the requirements 
of this section or the published criteria for ac-
creditation, or poses a threat to public health, 
or fails to act in a manner that is consistent 
with the purposes of this section. 
‘‘(F) REACCREDITATION.—Accredited per-
sons may be initially accredited for up to 4 
years. After expiration of such initial period, 
persons may be reaccredited for unlimited addi-
tional 4-year periods, as determined by the Sec-
retary. 
‘‘(c) QUALIFICATIONS OF ACCREDITED PERSONS.— 
‘‘(1) ELIGIBILITY.—An accredited person, at a 
minimum, shall— 
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‘‘(A) not be an employee of the Federal 
Government; 
‘‘(B) not engage in the activities of a de-
veloper, as defined in section 587(7); 
‘‘(C) not be a person required to register 
under section 587I, unless such person has es-
tablished sufficient processes and protocols to 
separate activities to develop in vitro clinical 
tests and the activities for which such person 
would be accredited under subsection (a) and 
discloses applicable information under this sec-
tion; 
‘‘(D) not be owned or controlled by, and 
shall have no organizational, material or finan-
cial affiliation with, an in vitro clinical test de-
veloper or other person required to register 
under section 587I; 
‘‘(E) be a legally constituted entity per-
mitted to conduct the activities for which it 
seeks accreditation; 
‘‘(F) ensure that the operations of such 
person are in accordance with generally accept-
ed professional and ethical business practices; 
and 
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‘‘(G) include in its request for accredita-
tion a commitment to, at the time of accredita-
tion and at any time it is performing activities 
pursuant to this section— 
‘‘(i) certify that the information re-
ported to the Secretary accurately reflects 
the data or protocol reviewed, and the doc-
umented inspection findings, as applicable; 
‘‘(ii) limit work to that for which com-
petence and capacity are available; 
‘‘(iii) treat information received or 
learned, records, reports, and recommenda-
tions as proprietary information of the per-
son submitting such information; and 
‘‘(iv) in conducting the activities for 
which the person is accredited in respect to 
a particular in vitro clinical test, protect 
against the use of any employee or consult-
ant who has a financial conflict of interest 
regarding that in vitro clinical test. 
‘‘(2) WAIVER.—The Secretary may waive any 
requirements in subparagraph (A), (B), (C), or (D) 
of paragraph (1) upon making a determination that 
such person has implemented other appropriate con-
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trols sufficient to ensure a competent and impartial 
review. 
‘‘(d) COMPENSATION OF ACCREDITED PERSONS.— 
‘‘(1) IN
GENERAL.—Compensation of an ac-
credited person who reviews an application for pre-
market approval submitted under section 587B or 
an application for technical certification submitted 
under section 587D shall be determined by agree-
ment between the accredited person and the person 
who engages the services of the accredited person, 
and shall be paid by the person who engages such 
services. 
‘‘(2) INSPECTION ACCREDITATION.—Compensa-
tion of an accredited person who is conducting an 
inspection under section 704 shall be determined by 
agreement between the accredited person and the 
person who engages the services of the accredited 
person, and shall be paid by the person who engages 
such services. 
‘‘(e) COOPERATIVE AGREEMENTS.—The Secretary is 
authorized to enter into cooperative arrangements with of-
ficials of foreign countries to ensure that adequate and 
effective means are available for purposes of determining, 
from time to time, whether in vitro clinical tests intended 
for use in the United States by a person whose facility 
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is located outside the United States shall be refused ad-
mission on any of the grounds set forth in section 801(a). 
‘‘(f) INFORMATION SHARING AGREEMENTS.—An ac-
credited person may enter into an agreement with a test 
developer to provide information to the comprehensive test 
information system under section 587T, including any re-
quirements under section 587I. 
‘‘SEC. 587Q. RECOGNIZED STANDARDS. 
‘‘(a) IN GENERAL.—The Secretary may by order es-
tablish performance standards for an in vitro clinical test 
or tests with the same indication for use to provide reason-
able assurance of the analytical validity, clinical validity, 
or as applicable safety, of that in vitro clinical test or tests 
with the same indications for use. 
‘‘(b) OTHER STANDARDS.—The Secretary may recog-
nize all or part of appropriate standards established by 
nationally or internationally recognized standard develop-
ment organizations for which a person may submit a dec-
laration of conformity in order to meet a requirement 
under this subchapter to which that standard is applicable. 
In recognizing a standard, any person requesting recogni-
tion of a standard or seeking to use a recognized standard, 
the Secretary shall follow the processes and requirements, 
in accordance with section 514(c). Standards for in vitro 
diagnostic devices previously recognized under section 
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514(c) shall be considered recognized standards under this 
section. The application of any such consensus standard 
shall only apply prospectively. The Secretary shall issue 
guidance establishing the criteria and process for such rec-
ognition and adoption. 
‘‘(c) ORDER PROCESS.—In establishing a standard 
under subsection (a), the Secretary shall issue a draft 
order proposing to establish a standard and shall provide 
for a comment period of not less than 60 calendar days. 
The Secretary may seek the recommendation of an advi-
sory committee under section 587G concerning a proposed 
standard either prior to or after issuance of a proposed 
order. After considering the comments and within 90 days 
of the close of the comment period, the Secretary shall 
issue a final order adopting the proposed standard, adopt-
ing a modification of the proposed standard or terminating 
the proceeding. 
‘‘(d) AMENDMENT PROCESS.—The procedures estab-
lished in this section or in guidance issued under this sec-
tion shall apply to amendment of an existing standard. 
‘‘SEC. 587R. INVESTIGATIONAL USE. 
‘‘(a) IN GENERAL.—Except as provided in subsection 
(c), an in vitro clinical test for investigational use shall 
be exempt from the requirements of this subchapter other 
than sections 587A, 587O, and 587U. 
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‘‘(b) REGULATIONS.—Not later than 2 years after 
the date of enactment of the Verifying Accurate Leading- 
edge IVCT Development Act of 2021, the Secretary shall 
promulgate regulations to implement this section. 
‘‘(c) APPLICATION FOR INVESTIGATIONAL USE.— 
‘‘(1) IN GENERAL.—The following shall apply 
with respect to in vitro clinical tests for investiga-
tional use: 
‘‘(A) STREAMLINING
APPLICATIONS
SUB-
MITTED UNDER THIS SECTION.—Requirements 
with respect to such tests shall be completed in 
accordance with current, at the time of submit-
ting the application, investigational use require-
ments for institutional review boards and cur-
rent processes for any analytical or clinical vali-
dation. 
‘‘(B) VARIATION.—The requirements in 
the regulations promulgated under this section 
shall take into account variations based on— 
‘‘(i) the scope and duration of clinical 
testing to be conducted under investigation 
that is the subject of such application; 
‘‘(ii) the number of human subjects 
that are to be involved in such testing; 
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‘‘(iii) the need to permit changes to be 
made in the in vitro clinical test involved 
during testing conducted in accordance 
with a plan required under paragraph 
(3)(B); or 
‘‘(iv) whether the clinical testing of 
such in vitro clinical test is for the purpose 
of developing data to obtain approval to 
offer such test. 
‘‘(C) SIGNIFICANT RISK STUDIES.—In the 
case of an in vitro clinical test the investiga-
tional use of which poses a significant risk, a 
sponsor of an investigation of such a test seek-
ing an investigational use exemption shall sub-
mit to the Secretary an investigational use ap-
plication with respect to the test in accordance 
with paragraphs (2) and (3). For purposes of 
this subparagraph, the term ‘significant risk’ 
means, with respect to an in vitro clinical test 
that is a high-risk test, and that the use of the 
test— 
‘‘(i) is a use of substantial importance 
in performing an activity or activities de-
scribed in subsection (ss)(1)(A) for, a seri-
ous or life-threatening disease or condition 
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without confirmation of the diagnosis by a 
medically established means; 
‘‘(ii) requires an invasive sampling 
procedure that presents a significant risk 
to the human subject; or 
‘‘(iii) otherwise presents a reasonably 
foreseeable serious risk to the health of a 
human subject. 
‘‘(D) NON-SIGNIFICANT
RISK
TESTS.—In 
the case of an in vitro clinical test, the inves-
tigational use of which does not pose a signifi-
cant risk— 
‘‘(i) the sponsor of such investigation 
shall— 
‘‘(I) conduct such investigation in 
compliance with an investigational 
plan specified in paragraph (5) and 
labeling 
specified 
in 
paragraph 
(3)(A)(ii); 
‘‘(II) ensure each investigator ob-
tains informed consent under part 50 
of title 21, Code of Federal Regula-
tions (or any successor regulations), 
subject to the exceptions set forth in 
paragraphs (5)(A)(iii) and (5)(B); 
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‘‘(III) submit a listing to the Sec-
retary of such investigation; and 
‘‘(IV) maintain records with re-
spect to all requirements in this sub-
paragraph; and 
‘‘(ii) the sponsor may rely on any ex-
ception or exemption identified in para-
graph (5)(B) or as established by the Sec-
retary in regulations issued under sub-
section (b). 
‘‘(2) APPLICATION
CONTENT.—An investiga-
tional use application shall be submitted in such 
time and manner and contain such information as 
the Secretary may require in regulation, and shall 
include an investigational plan for proposed clinical 
testing and assurances that the sponsor submitting 
the application will— 
‘‘(A) establish and maintain records rel-
evant to the investigation of such in vitro clin-
ical test; and 
‘‘(B) submit to the Secretary annual re-
ports of data obtained as a result of the inves-
tigational use of the in vitro clinical test during 
the period covered by the exemption that the 
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Secretary reasonably determines will enable the 
Secretary— 
‘‘(i) to ensure compliance with the 
conditions for the exemption specified in 
paragraph (3); 
‘‘(ii) to review the progress of the in-
vestigation involved; and 
‘‘(iii) to evaluate the analytical valid-
ity and clinical validity of such test. 
‘‘(3) CONDITIONS FOR EXEMPTION.— 
‘‘(A) IN GENERAL.—A request for an in-
vestigational use exemption with respect to sig-
nificant risk tests shall be granted only if each 
of the following conditions is met: 
‘‘(i) The risks to the subjects of the in 
vitro clinical test are outweighed by the an-
ticipated benefits to the subjects and the 
importance of the knowledge to be gained, 
and adequate assurance of informed con-
sent is provided in accordance with para-
graph (5)(A)(iii). 
‘‘(ii) The proposed labeling for the in 
vitro clinical test involved clearly and con-
spicuously states ‘For investigational use’. 
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‘‘(iii) Such other requirements the 
Secretary determines to be necessary for 
the protection of the public health and 
safety as long as the requirements do not 
unduly delay investigation after finding 
that the results of such investigation estab-
lish sufficient data to support clinical or 
analytical validity. 
‘‘(B) CERTAIN SIGNIFICANT RISK IN VITRO 
CLINICAL TESTS FOR AN UNMET NEED.—As a 
condition for granting an exemption under this 
paragraph, the Secretary shall not impose a 
limit on the sample size for a significant risk in 
vitro clinical test that meets the requirements 
of section 587C, as long as such test is devel-
oped within a laboratory that is certified to con-
duct high-complexity testing under section 353 
of the Public Health Service Act. 
‘‘(4) COORDINATION
WITH
INVESTIGATIONAL 
NEW
DRUG
APPLICATIONS.—Any requirement for 
the submission of a report to the Secretary pursuant 
to a request for an investigational new drug exemp-
tion involving an in vitro clinical test shall supersede 
the reporting requirement in paragraph (2)(B), but 
only to the extent the requirement with respect to 
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the request for exemption with respect to the drug 
is duplicative of the reporting requirement under 
such paragraph. 
‘‘(5) INVESTIGATION PLAN REQUIREMENTS.— 
‘‘(A) IN GENERAL.—With respect to an in-
vestigational plan submitted under paragraph 
(2)(A), the sponsor submitting such plan 
shall— 
‘‘(i) in the case of such a plan sub-
mitted to an institutional review com-
mittee, promptly notify the Secretary of 
the approval or the suspension or termi-
nation of the approval of such plan by an 
institutional review committee; 
‘‘(ii) in the case of an in vitro clinical 
test made available to investigators for 
clinical testing, assurance that all inves-
tigators will comply with this section, regu-
lations promulgated or revised under this 
section, and applicable human subjects reg-
ulations; and 
‘‘(iii) submit an assurance to the Sec-
retary that informed consent will be ob-
tained from each human subject (or the 
representative of such subject) of proposed 
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clinical testing involving such in vitro clin-
ical test, except in the case that— 
‘‘(I) there is a life-threatening 
situation involving the human subject 
of such testing which necessitates the 
use of such in vitro clinical test; 
‘‘(II) it is not feasible to obtain 
informed consent from the subject; 
and 
‘‘(III) there is not sufficient time 
to obtain such consent from a rep-
resentative of such subject. 
‘‘(B) EXCEPTION.—The informed consent 
of human subjects shall not be required with re-
spect to clinical testing conducted as part of an 
investigation, if— 
‘‘(i) the clinical testing uses remnants 
of specimens collected for routine clinical 
care or analysis that would have been dis-
carded, leftover specimens that were pre-
viously collected for other research pur-
poses, or specimens obtained from speci-
men repositories; 
‘‘(ii) the identity of the subject of the 
specimen is not known to, and may not 
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readily be ascertained by, the investigator 
or any other individual associated with the 
investigation, including the sponsor; 
‘‘(iii) any clinical information that ac-
companies the specimens does not make 
the specimen source identifiable to the in-
vestigator or any other individual associ-
ated with the investigation, including the 
sponsor; 
‘‘(iv) the individuals caring for the 
human subjects as patients are different 
from, and do not share information about 
the patient with, the individuals conducting 
the investigation; and 
‘‘(v) the specimens are provided to the 
investigators without personally identifiable 
information and the supplier of the speci-
mens has established policies and proce-
dures to prevent the release of personally 
identifiable information. 
‘‘(d) REVIEW OF APPLICATIONS.— 
‘‘(1) IN GENERAL.—The Secretary may issue 
an order approving an investigation as proposed, ap-
proving it with conditions or modifications, or dis-
approving it. 
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‘‘(2) FAILURE TO ACT.—Unless the Secretary, 
not later than the date that is 30 calendar days 
after the date of the submission of an investigational 
use exemption request that meets the requirements 
of subsection (c)(2), issues an order under sub-
section (d)(1) and notifies the sponsor submitting 
the application, the request shall be treated as 
granted as of such date without further action by 
the Secretary. 
‘‘(3) DISAPPROVAL.—The Secretary may deny 
an investigational use request submitted under this 
subsection if the Secretary determines that the in-
vestigation with respect to which the request is sub-
mitted does not conform to the requirements of sub-
section (c)(3). A listing of such denial submitted to 
the sponsor with respect to such a request shall con-
tain the order of disapproval and a complete state-
ment of the reasons for the Secretary’s denial of the 
request. 
‘‘(e) WITHDRAWAL OF APPROVAL.— 
‘‘(1) IN GENERAL.—The Secretary may, by ad-
ministrative order, withdraw an exemption granted 
under this section with respect to an in vitro clinical 
test, including an exemption granted based on the 
Secretary’s failure to act pursuant to subsection 
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(d)(2), if the Secretary determines that the test does 
not meet the applicable conditions under subsection 
(c)(3) for such exemption. 
‘‘(2) OPPORTUNITY TO BE HEARD.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), an order withdrawing the exemption 
granted under this section may be issued only 
after the Secretary provides the applicant or 
sponsor of the test with an opportunity for an 
informal hearing. 
‘‘(B) EXCEPTION.—An order referred to in 
subparagraph (A) with respect to an exemption 
granted under this subsection may be issued on 
a preliminary basis before the provision of an 
opportunity for an informal hearing if the Sec-
retary determines that the continuation of test-
ing under the exemption will result in an unrea-
sonable risk to the public health. The Secretary 
will provide an opportunity for an informal 
hearing promptly following any preliminary ac-
tion under this subparagraph. 
‘‘(f) CHANGES.— 
‘‘(1) IN
GENERAL.—The regulations promul-
gated under subsection (b) shall provide, with re-
spect to an in vitro clinical test for which an exemp-
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tion under this subsection is in effect, procedures 
and conditions under which the changes to the test 
are allowed without the additional determination on 
a request for an exemption or submission of a sup-
plement to such a request. Such regulations shall 
provide that such a change may be made if— 
‘‘(A) the sponsor or applicant determines, 
on the basis of credible information (as defined 
by the Secretary) that the change meets the 
conditions specified in paragraph (2); and 
‘‘(B) the sponsor or applicant submits to 
the Secretary, not later than 5 calendar days 
after making the change, a notice of the 
change. 
‘‘(2) CONDITIONS.—The conditions specified in 
this paragraph are that— 
‘‘(A) in the case of developmental changes 
to an in vitro clinical test (including manufac-
turing changes), the changes— 
‘‘(i) do not constitute a significant 
change in design or in basic principles of 
operation; 
‘‘(ii) do not affect the rights, safety, 
or welfare of the human subjects (if any) 
involved in the investigation; and 
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‘‘(iii) are made in response to infor-
mation gathered during the course of an 
investigation; and 
‘‘(B) in the case of changes to clinical pro-
tocols applicable to the test, the changes do not 
affect— 
‘‘(i) the validity of data or information 
resulting from the completion of an ap-
proved clinical protocol; 
‘‘(ii) the scientific soundness of a plan 
submitted under subsection (c)(5); or 
‘‘(iii) the rights, safety, or welfare of 
the human subjects (if any) involved in the 
investigation. 
‘‘(g) CLINICAL HOLD.— 
‘‘(1) IN GENERAL.—At any time, the Secretary 
may impose a clinical hold with respect to an inves-
tigation of an in vitro clinical test if the Secretary 
makes a determination described in paragraph (2). 
The Secretary shall, in imposing such clinical hold, 
specify the basis for the clinical hold, including the 
specific information available to the Secretary which 
served as the basis for such clinical hold, and con-
firm such determination in writing. The applicant or 
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