an application under this section, the Secretary re-
fuses to file such application, the Secretary shall 
provide to the developer, within 60 calendar days of 
receipt of such application, a description of the rea-
son for such refusal, and identify the information re-
quired, if any, to allow for the filing of the applica-
tion. 
‘‘(5) SUBSTANTIVE REVIEW FOR DEFICIENT AP-
PLICATION.—If, after receipt of an application under 
this section, the Secretary determines that any por-
tion of such application is deficient, the Secretary 
shall provide to the applicant, within 75 calendar 
days of receipt of such application, a description of 
such deficiencies and identify the information re-
quired to correct such deficiencies. 
‘‘(d) SPECIAL PREMARKET REVIEW.— 
‘‘(1) IN GENERAL.—Any person may file with 
the Secretary an application for special premarket 
approval for— 
‘‘(A) an instrument; 
‘‘(B) a specimen receptacle; 
‘‘(C) an in vitro clinical test eligible for a 
technology certification order under section 
587D; or 
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‘‘(D) a first-of-a-kind test, unless it is a 
high-risk test, a direct-to-consumer test, or 
cross-referenced test that does not have miti-
gating measures. 
‘‘(2) APPLICATION
CONTENT.—An application 
under paragraph (1) shall include— 
‘‘(A) the information required for applica-
tions submitted under subsection (c)(2), except 
that applications under paragraph (1) need not 
include— 
‘‘(i) quality requirement information; 
or 
‘‘(ii) raw data unless explicitly re-
quested by the Secretary; 
‘‘(B) in the case of a specimen receptacle, 
safety information; and 
‘‘(C) data, as applicable, to support soft-
ware validation, electromagnetic compatibility, 
and electrical safety, and information dem-
onstrating compliance with maintaining quality 
systems documentation. 
‘‘(3) INSPECTIONS.—With respect to an appli-
cation under paragraph (1), preapproval inspections 
authorized by an employee of the Food and Drug 
Administration or a person accredited under section 
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587P need not occur unless requested by the Sec-
retary. 
‘‘(e) INSTRUMENT FAMILY.—When an in vitro clin-
ical test has been approved, or is otherwise legally mar-
keted, for use on a specific approved or legally marketed 
instrument within an instrument family, a submission 
under this section shall not be required for that in vitro 
clinical test in order for it to be used on a new instrument 
within that instrument’s family. 
‘‘(f) AMENDMENTS TO AN APPLICATION.— 
‘‘(1) IN GENERAL.—An applicant may amend 
an original or supplemental application under sub-
section (c) or (d). 
‘‘(2) REQUIRED
AMENDMENT
OR
SUPPLE-
MENT.—An applicant shall amend or supplement an 
application submitted under subsection (c) or (d) if 
the applicant becomes aware of information that— 
‘‘(A) could reasonably affect an evaluation 
of whether the applicable standard has been 
met; or 
‘‘(B) could reasonably affect the statement 
of contraindications, warnings, precautions, and 
adverse reactions in the proposed labeling. 
‘‘(3) REQUEST FOR AMENDMENT OR SUPPLE-
MENT.—The Secretary may request that an appli-
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cant amend or supplement an application under sub-
section (c) or (d) with any information necessary for 
review under this section. 
‘‘(g) ACTION ON AN APPLICATION FOR PREMARKET 
APPROVAL.— 
‘‘(1) REVIEW.— 
‘‘(A) DISPOSITION.—As promptly as pos-
sible, but not later than 90 calendar days after 
an application under subsection (c) is accepted 
for submission (unless the Secretary determines 
that an extension is necessary to review one or 
more major amendments to the application), or 
not later than 60 calendar days after an appli-
cation under subsection (d) is accepted for sub-
mission, the Secretary, after considering any 
applicable report and recommendations pursu-
ant to advisory committees under section 587G, 
or prior to the establishment of such advisory 
committees, any recommendations by a classi-
fication panel under section 513, shall issue an 
order approving the application, unless the Sec-
retary finds that the grounds for approval in 
paragraph (2) are not met. 
‘‘(B) RELIANCE
ON
PROPOSED
LABEL-
ING.—In determining whether to approve or 
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deny an application under paragraph (1), the 
Secretary shall rely on the intended use in-
cluded in the proposed labeling, provided that 
such labeling is not false or misleading based on 
a fair evaluation of all material facts. 
‘‘(2) APPROVAL OF AN APPLICATION.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
approve an application submitted under sub-
section (c) with respect to an in vitro clinical 
test if the Secretary finds that there is a rea-
sonable assurance that the applicable standard 
is met, and— 
‘‘(i) except as provided under sub-
section (d), the applicant is in compliance 
with applicable quality requirements in sec-
tion 587J or as otherwise specified in a 
condition of approval, or maintains the 
documentation required to be in compli-
ance with such requirements if the appli-
cant is not required to submit such docu-
mentation as a part of the application 
under this section; 
‘‘(ii) the application does not contain 
a false statement of material fact; 
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‘‘(iii) based on a fair evaluation of all 
material facts, the proposed labeling is 
truthful and non-misleading and complies 
with the requirements of section 587K; 
‘‘(iv) except as provided under sub-
section (d), the applicant permits, if re-
quested, authorized employees of the Food 
and Drug Administration and persons ac-
credited under section 587P an oppor-
tunity— 
‘‘(I) to inspect at a reasonable 
time and in a reasonable manner the 
facilities and all pertinent equipment, 
finished and unfinished materials, 
containers, and labeling therein, in-
cluding all things (including records, 
files, papers, and controls) bearing on 
whether an in vitro clinical test is 
adulterated, misbranded, or otherwise 
in violation of this Act; and 
‘‘(II) to view and to copy and 
verify all records pertinent to the ap-
plication and the in vitro clinical test; 
‘‘(v) the test conforms with any appli-
cable performance standards under section 
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tended use may meet an exemption set 
forth in section 587A. 
‘‘(D) PUBLICATION.—The Secretary shall 
publish each order approving an application 
pursuant to this paragraph on the public 
website of the Food and Drug Administration 
and make publicly available a summary of the 
data used to grant the approval, except to the 
extent the Secretary determines that such 
order— 
‘‘(i) contains commercially confidential 
or trade secret information; or 
‘‘(ii) relates to national security or 
countermeasures is restricted from disclo-
sure pursuant to statutory provisions other 
than this section. 
‘‘(3) REVIEW
OF
DENIALS.—An applicant 
whose application submitted under subsection (c) or 
(d) has been denied approval may, by petition filed 
not more than 60 calendar days after the date on 
which the applicant receives notice of such denial, 
obtain review of the denial in accordance with sec-
tion 587O. 
‘‘(h) SUPPLEMENTS TO AN APPLICATION.— 
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‘‘(1) RISK
ANALYSIS.—Prior to implementing 
any modification to an in vitro clinical test, the hold-
er of the application approved under subsection (c) 
or (d) for such test shall perform risk analyses in 
accordance with section 587J, unless such modifica-
tion is included in the change protocol submitted by 
the applicant and approved under this section or ex-
empt under section 587A(l). 
‘‘(2) SUPPLEMENT REQUIREMENT.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), or otherwise specified by the 
Secretary, the holder of the application ap-
proved under subsection (g) for an in vitro clin-
ical test shall submit to the Secretary and re-
ceive approval of a supplement before imple-
menting a modification to the test, unless such 
modification is exempt under section 587A(l). 
‘‘(B) ADJUSTMENTS
TO
CHANGE
PRO-
TOCOL.—A person may submit under this para-
graph a supplemental application adjusting the 
change protocol of the test at any time after the 
initial filing of an application under subsection 
(c) or (d). 
‘‘(C) EXCEPTIONS.—Subject to subpara-
graphs (D) and (E), and so long as the holder 
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of an approved application submitted under 
subsection (c) or (d) for an in vitro clinical test 
does not add a manufacturing site, or change 
activities at an existing manufacturing site, 
with respect to the test, the holder may, with-
out prior approval of a supplement, implement 
the following modifications to the test: 
‘‘(i) Modifications included in and im-
plemented in accordance with an approved 
change protocol under subsection (c)(2)(I). 
‘‘(ii) 
Modifications 
that 
do 
not 
change— 
‘‘(I) the analytical or clinical va-
lidity of the test; 
‘‘(II) the intended use of the test 
unless provided under an approved 
change 
protocol 
under 
subsection 
(c)(2)(I); or 
‘‘(III) the safety of the specimen 
receptacles. 
‘‘(iii) Labeling changes to address a 
safety concern. 
‘‘(iv) Modifications that are exempt 
under section 587A(l). 
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‘‘(D) REPORTING FOR CHANGE PROTOCOL 
MODIFICATIONS.—As a component of the report 
required under subsection (k), the holder of an 
application approved under subsection (g) for 
an in vitro clinical test shall— 
‘‘(i) report any modification to the 
test described in clause (i) or (ii) of sub-
paragraph (B) in the next annual report 
for the test under subsection (k) following 
the date on which the test, with such modi-
fication, is introduced into interstate com-
merce; and 
‘‘(ii) include in such report— 
‘‘(I) a description of the modi-
fication; and 
‘‘(II) as applicable, a summary of 
the analytical validity and clinical va-
lidity of the test, as modified, and any 
changes to acceptance criteria. 
‘‘(E) REPORTING FOR OTHER CATEGORY 
OF EXCEPTIONS.—The holder of the application 
approved under subsection (c) or (d) for an in 
vitro clinical test shall— 
‘‘(i) report to the Secretary any modi-
fication to the test described in clause (iii) 
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of subparagraph (C) not more than 60 
days after the date on which the test, with 
the modification, is introduced into inter-
state commerce; and 
‘‘(ii) include in the report— 
‘‘(I) a summary of the relevant 
change or changes; 
‘‘(II) the rationale for imple-
menting such change or changes; and 
‘‘(III) a description of how the 
change or changes were evaluated. 
‘‘(F) REQUEST FOR SUPPLEMENT.—Upon 
review of the information received under sub-
paragraph (D) and a finding that the relevant 
modification is inconsistent with the standard 
specified under subparagraph (C), the Secretary 
may require a supplement under subparagraph 
(A). If the Secretary determines that a supple-
ment under subparagraph (A) is required, the 
Secretary shall notify the applicant of such de-
termination. Such notification shall include a 
justification for the submission of a supplement. 
Prior to the submission of a supplement under 
this subparagraph, the applicant may request a 
meeting or written correspondence to gain agen-
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cy feedback as to the necessity of such supple-
mental filing. The Secretary shall respond to 
such meeting request within 30 calendar days 
of receipt. 
‘‘(3) CONTENTS OF SUPPLEMENT.—Unless oth-
erwise specified by the Secretary, a supplement 
under this subsection shall include— 
‘‘(A) for modifications other than manufac-
turing site changes— 
‘‘(i) a description of the modification; 
‘‘(ii) data to demonstrate that the ap-
plicable standard is met; 
‘‘(iii) acceptance criteria; and 
‘‘(iv) any revised labeling; and 
‘‘(B) for manufacturing site changes— 
‘‘(i) the matter listed in subparagraph 
(A); and 
‘‘(ii) information regarding the meth-
ods used in, or the facilities or controls 
used for, the development of the test to 
demonstrate compliance with the applicable 
quality requirements under section 587J. 
‘‘(4) ADDITIONAL DATA.—The Secretary may 
require, when necessary, data to evaluate a modifica-
tion to an in vitro clinical test that is in addition to 
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the data otherwise required under the preceding 
paragraphs if the data request is in accordance with 
the least burdensome requirements under subsection 
(j). 
‘‘(5) CONDITIONS OF APPROVAL.—In an order 
approving a supplement under this subsection, the 
Secretary may require conditions of approval for the 
in vitro clinical test, including compliance with re-
strictions under section 587N and conformance to 
performance standards under section 587Q. 
‘‘(6) APPROVAL.—The Secretary shall approve 
a supplement under this subsection if— 
‘‘(A) the data demonstrate that the modi-
fied in vitro clinical test meets the applicable 
standard; and 
‘‘(B) the holder of the application approved 
under subsection (g) for the test has dem-
onstrated compliance with applicable quality 
and inspection requirements, as applicable and 
appropriate. 
‘‘(7) PUBLICATION.—The Secretary shall pub-
lish on the public website of the Food and Drug Ad-
ministration notice of any order approving a supple-
ment under this subsection, except that such publi-
cation shall exclude— 
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‘‘(A) commercial confidential or trade se-
cret information; and 
‘‘(B) any other information that the Sec-
retary determines to relate to national security 
or countermeasures or to be restricted from dis-
closure pursuant to another provision of law. 
‘‘(8) REVIEW OF DENIAL.—An applicant whose 
supplement under this subsection has been denied 
approval may, by petition filed on or before the 60th 
calendar day after the date upon which the applicant 
receives notice of such denial, obtain review of the 
denial in accordance with section 587O. 
‘‘(i) WITHDRAWAL AND TEMPORARY SUSPENSION OF 
APPROVAL.— 
‘‘(1) ORDER WITHDRAWING APPROVAL.— 
‘‘(A) IN
GENERAL.—The Secretary may, 
within 10 calendar days of providing due notice 
and an opportunity for an informal hearing to 
the holder of an approved application for an in 
vitro clinical test under this section, issue an 
order withdrawing approval of the application if 
the Secretary finds that— 
‘‘(i) the grounds for approval in sub-
section (g) are no longer met; or 
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‘‘(ii) there is a reasonable likelihood 
that the test would cause death or serious 
adverse health consequences, including by 
causing the absence, delay, or discontinu-
ation of life-saving or life sustaining med-
ical treatment. 
‘‘(B) CONTENT.—An order under subpara-
graph (A) withdrawing approval of an applica-
tion shall state each ground for withdrawal and 
shall notify the holder of such application 60 
calendar days prior to issuing such order. 
‘‘(C) PUBLICATION.—The Secretary shall 
publish any order under subparagraph (A) on 
the public website of the Food and Drug Ad-
ministration, except that such publication shall 
exclude— 
‘‘(i) commercial confidential or trade 
secret information; and 
‘‘(ii) any other information that the 
Secretary determines to relate to national 
security or countermeasures or to be re-
stricted from disclosure pursuant to an-
other provision of law. 
‘‘(2) ORDER OF TEMPORARY SUSPENSION.—If, 
after providing due notice and an opportunity for an 
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informal hearing to the holder of an approved appli-
cation for an in vitro clinical test under this section, 
the Secretary determines there is a reasonable likeli-
hood that the in vitro clinical test would cause death 
or serious adverse health consequences, including by 
causing the absence, delay, or discontinuation of life- 
saving or life-sustaining medical treatment, the Sec-
retary shall by order temporarily suspend the ap-
proval of the application. If the Secretary issues 
such an order, the Secretary shall proceed expedi-
tiously under paragraph (1) to withdraw approval of 
such application. 
‘‘(j) LEAST BURDENSOME REQUIREMENTS.— 
‘‘(1) IN GENERAL.—In carrying out this sub-
chapter, the Secretary shall consider the least bur-
densome means necessary to provide a reasonable 
assurance of analytical and clinical validity, or appli-
cable standard, and other regulatory requirements, 
as determined by the Secretary. 
‘‘(2) NECESSARY DEFINED.—For purposes of 
paragraph (1) and paragraph (3), the term ‘nec-
essary’ means the minimum required information 
that would support a determination by the Secretary 
that the application provides a reasonable assurance 
of analytical and clinical validity, or other applicable 
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standard or regulatory requirement, as determined 
by the Secretary. 
‘‘(3) 
CONSIDERATION
OF
ROLE
OF 
POSTMARKET INFORMATION.—For purposes of this 
subsection, the Secretary shall consider the role of 
postmarket information in determining the least bur-
densome appropriate means necessary to dem-
onstrate that the applicable standard and other reg-
ulatory requirements have been met. 
‘‘(k) ANNUAL REPORT.— 
‘‘(1) IN GENERAL.—Unless the Secretary speci-
fies otherwise, the holder of an approved application 
under this section shall submit an annual report 
each year at a time designated by the Secretary in 
the approval order. Such report shall— 
‘‘(A) identify all modifications required to 
be reported that an approved application holder 
has made to any test that is covered by the ap-
proval order, including any modification that 
requires a supplement under subsection (h)(2); 
and 
‘‘(B) include any other information re-
quired by the Secretary. 
‘‘(2) EXCEPTION.—The annual reporting re-
quirement in paragraph (1) shall not apply to in 
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vitro clinical tests that are deemed to have a pre-
market approval based on a prior approval under 
section 515(c), clearance under section 510(k), or 
authorization under section 513(f). 
‘‘(l) SERVICE OF ORDERS.—Orders of the Secretary 
under this section with respect to applications under sub-
section (c) or (d) or supplements under subsection (h) 
shall be served— 
‘‘(1) in person by any officer or employee of the 
Department of Health and Human Services des-
ignated by the Secretary; or 
‘‘(2) by mailing the order by registered mail or 
certified mail or electronic equivalent addressed to 
the applicant at the last known address in the 
records of the Secretary. 
‘‘SEC. 587C. BREAKTHROUGH IN VITRO CLINICAL TESTS. 
‘‘(a) IN GENERAL.—The purpose of this section is 
to encourage the Secretary and provide the Secretary with 
sufficient authority to apply efficient and flexible ap-
proaches to expedite the development of, and prioritize the 
review of, in vitro clinical tests that represent break-
through technologies. 
‘‘(b) ESTABLISHMENT OF PROGRAM.—The Secretary 
shall establish a program to expedite the development of, 
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and provide for the priority review of, in vitro clinical 
tests. 
‘‘(c) ELIGIBILITY.—The program developed under 
subsection (b) shall be available for any in vitro clinical 
test that— 
‘‘(1) provides or enables more effective treat-
ment or diagnosis of life-threatening or irreversibly 
debilitating human disease or conditions compared 
to existing approved or precertified alternatives; and 
‘‘(2) is a test— 
‘‘(A) that represents a breakthrough tech-
nology; 
‘‘(B) for which no approved or precertified 
alternative exists; 
‘‘(C) that offers a clinically meaningful ad-
vantage over existing approved or precertified 
alternatives, including the potential, compared 
to existing approved or precertified alternatives, 
to reduce or eliminate the need for hospitaliza-
tion, improve patient quality of life, facilitate 
patients’ ability to manage their own care (such 
as through self-directed personal assistance), or 
establish long-term clinical efficiencies; or 
‘‘(D) the availability of which is in the best 
interest of patients or public health. 
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‘‘(d) DESIGNATION.— 
‘‘(1) REQUEST.—To receive breakthrough ap-
proval under this section, an applicant may request 
that the Secretary designate the in vitro clinical test 
for expedited development and priority review. Any 
such request for designation may be made at any 
time prior to the submission of an application under 
section 587B, and shall include information dem-
onstrating that the test is eligible for designation 
under subsection (c). 
‘‘(2) DETERMINATION.—Not later than 60 cal-
endar days after the receipt of a request under para-
graph (1), the Secretary shall determine whether the 
in vitro clinical test that is the subject of the request 
meets the criteria described in subsection (c). If the 
Secretary determines that the test meets the criteria, 
the Secretary shall designate the test for expedited 
development and priority review. 
‘‘(3) REVIEW.—Review of a request under para-
graph (1) shall be undertaken by a team that is 
composed of experienced staff and senior managers 
of the Food and Drug Administration. 
‘‘(4) WITHDRAWAL.— 
‘‘(A) IN GENERAL.—The designation of an 
in vitro clinical test under this subsection is 
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deemed to be withdrawn, and such in vitro clin-
ical test shall no longer be eligible for designa-
tion under this section, if an application for ap-
proval under section 587B is denied. Such test 
would be eligible for designation upon a new re-
quest for such designation. 
‘‘(B) EXCEPTION.—The Secretary may not 
withdraw a designation granted under this sub-
section based on the subsequent approval or 
technology certification of another test that— 
‘‘(i) is designated under this section; 
or 
‘‘(ii) was given priority review under 
section 515B. 
‘‘(e) ACTIONS.—For purposes of expediting the devel-
opment and review of in vitro clinical tests under this sec-
tion, the Secretary may take the actions and additional 
actions set forth in section 515B(e) when reviewing such 
tests. Any reference or authorization in section 515B(e) 
with respect to a device shall be deemed a reference or 
authorization with respect to an in vitro clinical test for 
purposes of this section. 
‘‘(f) GUIDANCE.— 
‘‘(1) IN GENERAL.—Not later than one year 
after the date of enactment of the Verifying Accu-
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rate Leading-edge IVCT Development Act of 2020, 
the Secretary shall issue draft guidance on the im-
plementation of this section. Such guidance shall— 
‘‘(A) set forth the process by which a per-
son may seek a designation under subsection 
(d); 
‘‘(B) provide a template for request under 
subsection (d); 
‘‘(C) identify the criteria the Secretary will 
use in evaluating a request for designation; and 
‘‘(D) identify the criteria and processes the 
Secretary will use to assign a team of staff, in-
cluding team leaders, to review in vitro clinical 
tests designated for expedited development and 
priority review, including any training required 
for such personnel to ensure effective and effi-
cient review. 
‘‘(2) PROCESS.—Prior to finalizing the guid-
ance under paragraph (1), the Secretary shall seek 
public comment on the draft guidance. The Sec-
retary shall issue final guidance one year after the 
close of the comment period for the draft guidance. 
‘‘(g) ANNUAL REPORT.—Unless otherwise specified 
by the Secretary, the requirements under section 587B(k) 
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apply to in vitro clinical tests designated under this sec-
tion. 
‘‘(h) SERVICE OF ORDERS.—Orders of the Secretary 
under this section shall be served— 
‘‘(1) in person by any officer or employee of the 
Department of Health and Human Services des-
ignated by the Secretary; or 
‘‘(2) by mailing the order by registered mail or 
certified mail or electronic equivalent addressed to 
the applicant at his last known address in the 
records of the Secretary. 
‘‘SEC. 587D. TECHNOLOGY CERTIFICATION. 
‘‘(a) IN GENERAL.— 
‘‘(1) ELIGIBILITY.—Any eligible person may 
seek a technology certification in accordance with 
this section. 
‘‘(2) EXCEPTION.—An in vitro clinical test is 
exempt from premarket review under section 587B 
if the developer is eligible under this section and the 
in vitro clinical test— 
‘‘(A) is an eligible in vitro clinical test 
under subsection (b)(2); and 
‘‘(B) falls within the scope of a technology 
certification order issued under this section, 
and such order is in effect. 
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‘‘(b) ELIGIBILITY.— 
‘‘(1) ELIGIBLE PERSON.—In this section, the 
term ‘eligible person’ means an in vitro clinical test 
developer unless, at the time such person seeks or 
would seek technology certification order, the per-
son— 
‘‘(A) has been found to have committed a 
significant violation of section 353 of the Public 
Health Service Act, unless— 
‘‘(i) such violation occurred more than 
5 years prior to the date on which such 
technology certification order is or would 
be sought; 
‘‘(ii) such violation has been resolved; 
or 
‘‘(iii) such violation is not pertinent to 
any in vitro clinical test within the scope of 
the technology certification order that such 
person seeks or would seek; or 
‘‘(B) such person fails to maintain re-
quired certifications under section 353 of the 
Public Health Service Act; 
‘‘(C) has been found to have submitted in-
formation that— 
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‘‘(i) makes false or misleading state-
ments about a technology certification 
order previously issued or an application 
approved under section 587B; or 
‘‘(ii) violates any requirement of this 
subchapter related to technology certifi-
cation under this section or approval under 
section 587B, where such violation exposes 
persons to serious risk of illness, injury, or 
death. 
‘‘(2) ELIGIBLE IN VITRO CLINICAL TEST.—An 
in vitro clinical test is eligible under subsection 
(a)(2) for exemption from premarket review under 
section 587B unless— 
‘‘(A) such test is— 
‘‘(i) a component or part of an in 
vitro clinical test as described under sec-
tion 201(ss)(1)(B)(v); 
‘‘(ii) an instrument under section 
201(ss)(1)(B)(ii); 
‘‘(iii) a specimen receptacle under sec-
tion 201(ss)(1)(B)(iii); or 
‘‘(iv) an in vitro clinical test, including 
reagents used in such tests, intended for 
use for testing donors, donations, and re-
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cipients 
of 
blood, 
blood 
components, 
human cells, tissues, cellular-based prod-
ucts, or tissue-based products; or 
‘‘(B) unless otherwise permitted pursuant 
to section 587F, such test is— 
‘‘(i) a first-of-a-kind in vitro clinical 
test; 
‘‘(ii) a test system for home use; 
‘‘(iii) a high-risk in vitro clinical test; 
‘‘(iv) a cross-referenced in vitro clin-
ical test; or 
‘‘(v) a direct-to-consumer in vitro clin-
ical test. 
‘‘(c) PUBLIC MEETING AND INPUT.— 
‘‘(1) PUBLIC DOCKET.—Not later than 30 days 
after the date of enactment of the Verifying Accu-
rate Leading-edge IVCT Development Act of 2020, 
the Secretary shall establish a public docket to re-
ceive comments concerning recommendations for im-
plementation of this section, including criteria and 
procedures for subsections (e) through (j). The pub-
lic docket shall remain open for the duration of time 
that this section remains in effect. 
‘‘(2) PUBLIC
MEETING.—Not later than 180 
days after the date of enactment of the Verifying 
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Accurate Leading-edge IVCT Development Act of 
2020, the Secretary shall convene a public meeting 
to which stakeholders from organizations rep-
resenting patients and consumers, academia, and the 
in vitro clinical test industry are invited in order to 
discuss components of the technology certification 
process including application requirements, inspec-
tions, alignment with third-party accreditors, and 
the definition of ‘technology’ under section 587(17). 
The public meeting shall be assigned a docket num-
ber by the Commissioner of Food and Drugs and 
made available for the submission of public com-
ments. 
‘‘(d) GUIDANCE.—In accordance with section 5 of the 
Verifying Accurate Leading-edge IVCT Development Act 
of 2020, the Secretary shall issue a draft guidance on 
technology review including describing criteria or proce-
dures relating to technology review under this section, 
which shall be subject to public comment for a minimum 
of 60 days from issuance prior to finalizing such guidance 
documents after considering the comments received. The 
guidance shall include an outline of the application and 
recertification process, opportunities to meet with officials 
of the Food and Drug Administration, plans to streamline 
inspections, and a list of applicable technologies. The guid-
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ance shall be updated as appropriate, and not less fre-
quently than each time the Secretary identifies a unique 
technology. 
‘‘(e) APPLICATION
FOR
TECHNOLOGY
CERTIFI-
CATION.— 
‘‘(1) IN GENERAL.—A person seeking a tech-
nology certification order shall submit an application 
under this subsection, which shall contain the infor-
mation specified under paragraph (2). 
‘‘(2) CONTENT OF APPLICATION.—An applica-
tion for technology certification shall contain— 
‘‘(A) a statement identifying the scope of 
the proposed technology certification, which 
shall be no broader than a single technology in-
tended to be offered under the application; 
‘‘(B) information showing that the person 
seeking a technology certification order is an el-
igible person under subsection (b)(1); 
‘‘(C) information showing that the methods 
used in, and the facilities and controls used for, 
the development of eligible in vitro clinical tests 
covered by the scope of the technology certifi-
cation conform to the applicable quality require-
ments of section 587J; 
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‘‘(D) procedures for analytical validation, 
including all procedures for validation, verifica-
tion, and acceptance criteria, and an expla-
nation as to how such procedures, when used, 
provide a reasonable assurance of analytical va-
lidity of all eligible in vitro clinical tests within 
the proposed scope of technology certification 
order; 
‘‘(E) information showing that the person 
has an established clinical program, including 
procedures for clinical validation, including all 
procedures for validation, verification, and ac-
ceptance criteria, and an explanation as to how 
such procedures, when used, provide a reason-
able assurance of clinical validity of all eligible 
in vitro clinical tests within the proposed scope 
of technology certification order; 
‘‘(F) a notification under section 587I for 
each applicable in vitro clinical test that the de-
veloper plans to offer initially upon receiving a 
technology certification order and that would be 
introduced or delivered for introduction into 
interstate commerce upon the issuance of the 
technology certification order; 
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‘‘(G) information concerning one or more 
representative in vitro clinical tests, including— 
‘‘(i) one of the tests within the scope 
of the technology certification application 
with the greatest analytical complexity at 
the time of the filing of the application 
under this section that would be introduced 
or delivered for introduction into interstate 
commerce upon the issuance of the tech-
nology certification order to serve as the 
representative test and validate and run 
within the developer’s stated scope, and a 
rationale for such selection; 
‘‘(ii) the information specified in sub-
section (c) or (d) of section 587B for the 
representative in vitro clinical test or tests, 
except that raw data shall be provided for 
any such in vitro clinical test unless the 
Secretary determines otherwise; 
‘‘(iii) an explanation of the choice of 
the representative in vitro clinical test or 
tests for the technology certification appli-
cation and how such test adequately dem-
onstrates the range of procedures that the 
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developer includes in the application under 
subparagraphs (C), (D), (E), and (F); and 
‘‘(iv) a brief explanation of the ways 
in which the procedures included in the ap-
plication under subparagraphs (C), (D), 
(E), and (F) have been applied to the rep-
resentative in vitro clinical test or tests; 
‘‘(H) such other information relevant to 
the subject matter of the application as the Sec-
retary may require; and 
‘‘(I) a statement that the applicant believes 
to the best of the applicant’s knowledge that all 
data and information submitted to the Sec-
retary are truthful and accurate and that no 
material fact has been omitted. 
‘‘(f) ACTION ON AN APPLICATION FOR TECHNOLOGY 
CERTIFICATION.— 
‘‘(1) SECRETARY RESPONSE.— 
‘‘(A) IN GENERAL.—As promptly as prac-
ticable, and no later than 90 days after receipt 
of an application under subsection (c), the Sec-
retary shall— 
‘‘(i) issue a technology certification 
order granting the application, which shall 
specify the scope of the technology certifi-
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cation, if the Secretary finds that all of the 
grounds in paragraph (3) are met; or 
‘‘(ii) deny the application if the Sec-
retary finds (and sets forth the basis of 
such finding as part of or accompanying 
such denial) that one or more grounds for 
granting the application specified in para-
graph (3) are not met. 
‘‘(B) EXTENSION.—The timeline described 
in subparagraph (A) may be extended by mu-
tual agreement between the Secretary and the 
applicant. 
‘‘(2) DEFICIENT APPLICATIONS.—If, after re-
ceipt of an application under this section, the Sec-
retary determines that any portion of such applica-
tion is deficient, the Secretary, not later than 90 
days after receipt of such application, shall provide 
to the applicant a description of such deficiencies 
and identify the information required to correct such 
deficiencies. 
‘‘(3) APPROVAL.—The Secretary shall grant a 
technology certification order under this section if, 
on the basis of the information submitted to the Sec-
retary as part of the application and any other infor-
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mation with respect to such applicant, the Secretary 
finds that— 
‘‘(A) 
in 
accordance 
with 
subsection 
(e)(2)(D), there is a showing of reasonable as-
surance of analytical validity for all eligible in 
vitro clinical tests within the proposed scope of 
the technology certification, as evidenced by the 
procedures for analytical validation; 
‘‘(B) 
in 
accordance 
with 
subsection 
(e)(2)(E), there is a showing of reasonable as-
surance of clinical validity for all eligible in 
vitro clinical tests within the proposed scope of 
the technology certification, as evidenced by the 
clinical program, including procedures for clin-
ical validation; 
‘‘(C) the methods used in, or the facilities 
or controls used for, the development of eligible 
in vitro clinical tests covered by the proposed 
scope of the technology certification conform to 
the applicable requirements of section 587J; 
‘‘(D) based on a fair evaluation of all ma-
terial facts, the applicant’s proposed labeling 
and advertising is not false or misleading in any 
particular; 
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‘‘(E) the application does not contain a 
false statement of material fact; 
‘‘(F) there is a showing that the represent-
ative in vitro clinical test or tests— 
‘‘(i) meets the applicable standard for 
approval; and 
‘‘(ii) reasonably represent the range of 
procedures for analytical validation and 
clinical validation included in the applica-
tion, as applicable; and 
‘‘(G) the applicant permits authorized em-
ployees of the Food and Drug Administration 
or persons accredited under this Act an oppor-
tunity to inspect at a reasonable time and in a 
reasonable manner the facilities and all perti-
nent equipment, finished and unfinished mate-
rials, containers, and labeling therein, including 
all things (including records, files, papers, and 
controls) bearing on whether an in vitro clinical 
test is adulterated, misbranded, or otherwise in 
violation of this Act, and permits such author-
ized employees or persons accredited under this 
Act to view and to copy and verify all records 
pertinent to the application and the in vitro 
clinical test. 
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‘‘(4) REVIEW
OF
DENIALS.—An applicant 
whose application has been denied may, by petition 
filed on or before the date that is 30 calendar days 
after the date upon which such applicant receives 
notice of such denial, obtain review thereof in ac-
cordance with section 587O. 
‘‘(g) DURATION; SUBSEQUENT SUBMISSIONS.— 
‘‘(1) ORDER DURATION.—A technology certifi-
cation order shall remain in effect until the earlier 
of— 
‘‘(A) the expiration of such technology cer-
tification order under paragraph (2); or 
‘‘(B) the withdrawal of such technology 
certification order under subsection (j). 
‘‘(2) EXPIRATION.—An initial technology cer-
tification order issued under subsection (f)(3) shall 
expire on such date specified by the Secretary that 
is not later than 4 years after the date that such 
order is issued, except that if an application for re-
newal under paragraph (3) has been received not 
later than 30 days prior to the expiration of such 
order under this paragraph, such order shall expire 
on the date on which the Secretary has granted or 
denied the application for renewal. Any such subse-
quent renewal of a technology certification shall ex-
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pire on such date specified by the Secretary that is 
not later than 4 years after the date that such tech-
nology certification order is issued. 
‘‘(3) RENEWAL.— 
‘‘(A) IN
GENERAL.—Any person with a 
technology certification order in effect with re-
spect to development of in vitro clinical tests 
may seek renewal of such order provided that— 
‘‘(i) such person is an eligible person 
under subsection (b)(1); and 
‘‘(ii) none of the information specified 
in subsection (e)(2) has substantially 
changed, except as described in supple-
ments approved under paragraph (4). 
‘‘(B) CONTENT.—An application for re-
newal under this paragraph shall include infor-
mation concerning one or more representative 
in vitro clinical tests in accordance with sub-
section (e)(2)(G), except that such representa-
tive test or tests shall be different from the rep-
resentative test or tests relied upon as the rep-
resentative assay in any prior technology certifi-
cation that has not yet been reviewed, if appli-
cable. 
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‘‘(C) PROCESS.—The Secretary’s action on 
an application for renewal of technology certifi-
cation under this paragraph shall be conducted, 
to the extent practicable, in coordination with 
inspections conducted under section 353 of the 
Public Health Service Act, and any order re-
sulting from such renewal application shall be 
treated as a technology certification order for 
purposes of this subchapter. 
‘‘(4) SUPPLEMENTS AND REPORTS.— 
‘‘(A) SUPPLEMENTS.—Except as provided 
in subparagraph (B), any person with a tech-
nology certification order in effect may seek a 
supplement to such order upon a change or 
changes to the information provided in the ap-
plication for technology certification under sub-
paragraphs (C), (D), and (E) of subsection 
(e)(2), provided that— 
‘‘(i) such person is an eligible person 
under subsection (b)(1); and 
‘‘(ii) that such change does not ex-
pand the scope of the technology certifi-
cation unless the Secretary deems appro-
priate. 
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A supplement may contain only information rel-
evant to the change or changes. The Secretary’s 
action on a supplement shall be in accordance 
with subsection (f), and any order resulting 
from such supplement shall be treated as an 
amendment to a technology certification order 
that is in effect. 
‘‘(B) REPORTS.— 
‘‘(i) IN
GENERAL.—If a change de-
scribed in subparagraph (A) is made in 
order to address a potential risk to public 
health by adding a new specification or 
test method, the person may immediately 
implement such change or changes and 
shall report such changes or changes to the 
Secretary within 30 days. 
‘‘(ii) CONTENT.—Any report to the 
Secretary under this subparagraph shall 
include— 
‘‘(I) a summary of the relevant 
change or changes; 
‘‘(II) the rationale for imple-
menting such change or changes; and 
‘‘(III) a description of how the 
change or changes were evaluated. 
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‘‘(iii) 
SUPPLEMENTAL
REPORTS.— 
Upon review of such report and a finding 
that the relevant change or changes are in-
consistent with the standard specified 
under this subparagraph, the Secretary 
may require a supplement under subpara-
graph (A). 
‘‘(h) MAINTENANCE REQUIREMENTS.—For the dura-
tion of a technology certification order, a holder of a tech-
nology certification order shall— 
‘‘(1) use the procedures included in the relevant 
application, supplement, or report under subsections 
(b) and (e); 
‘‘(2) ensure compliance with any applicable 
mitigating measures; 
‘‘(3) maintain, and provide to the Secretary 
upon request, records related to any in vitro clinical 
test offered without premarket review under the 
technology certification order, where those records 
are necessary to demonstrate compliance with appli-
cable provisions of this subchapter; and 
‘‘(4) comply with the notification requirements 
under section 587I for each in vitro clinical test of-
fered without premarket review under the technology 
certification order. 
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‘‘(i) TEMPORARY HOLD.— 
‘‘(1) IN GENERAL.—Upon one or more findings 
under paragraph (4) and after promptly notifying 
the developer of such findings, the Secretary may 
issue a temporary hold prohibiting any holder of a 
technology certification order from introducing into 
interstate commerce an in vitro clinical test that was 
not previously the subject of a notification under 
section 587I. The temporary hold must identify the 
grounds for the temporary hold under paragraph (4) 
and the rationale for such finding. 
‘‘(2) NOTIFICATION TO THE DEVELOPER.—The 
Secretary shall not place a temporary hold under 
this subsection unless the Secretary has promptly 
notified the developer of such hold and provided 30 
calendar days for the developer to come into compli-
ance with or resolve the findings under paragraph 
(4). 
‘‘(3) WRITTEN
REQUESTS.—Any written re-
quest to the Secretary from the holder of a tech-
nology certification order that a temporary hold 
under paragraph (1) be removed shall receive a deci-
sion, in writing and specifying the reasons therefore, 
within 90 days after receipt of such request. Any 
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such request shall include information to support the 
removal of the temporary hold. 
‘‘(4) GROUNDS
FOR
TEMPORARY
HOLD.—A 
temporary hold under this subsection may be 
instated upon a finding or findings that the holder 
of a technology certification order— 
‘‘(A) is not in compliance with any mainte-
nance requirements under subsection (h); 
‘‘(B) labels or advertises one or more in 
vitro clinical tests with false or misleading 
claims; or 
‘‘(C) is no longer an eligible person under 
subsection (b)(1). 
‘‘(j) WITHDRAWAL.—The Secretary may, after due 
notice and opportunity for informal hearing, issue an 
order withdrawing a technology certification order if the 
Secretary finds that— 
‘‘(1) the application, supplement, or report 
under subsection (e) or (g) contains false or mis-
leading information or fails to reveal a material fact; 
‘‘(2) such holder fails to correct false or mis-
leading labeling or advertising upon the request of 
the Secretary; 
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100 
‘‘(3) in connection with a technology certifi-
cation, the holder provides false or misleading infor-
mation to the Secretary; or 
‘‘(4) the holder of such technology certification 
order fails to correct the grounds for temporary hold 
within a timeframe specified in the temporary hold 
order. 
‘‘(k) REPORTS TO CONGRESS.— 
‘‘(1) IN GENERAL.—Not later than one year 
after the effective date, and annually for 4 years 
thereafter, the Secretary shall prepare and submit to 
the Committee on Energy and Commerce of the 
House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate, and make publicly available, including through 
posting on the internet website of the Food and 
Drug Administration, a report containing the infor-
mation required under paragraph (2). 
‘‘(2) CONTENT.— 
‘‘(A) IN
GENERAL.—Each report under 
paragraph (1) shall address, at a minimum— 
‘‘(i) the total number and type of ap-
plications 
for 
technology 
certifications 
filed, granted, withdrawn or denied; 
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101 
‘‘(ii) the total number of technology 
certification orders put on temporary hold 
under subsection (i) and the number of 
technology certification orders withdrawn 
under subsection (j); 
‘‘(iii) the types of technologies for 
which technology certification orders were 
granted; and 
‘‘(iv) the total number of laboratories 
and developers with technology certifi-
cation orders in effect. 
‘‘(B) FINAL
REPORT.—The fifth report 
submitted under paragraph (1) shall include a 
summary of, and responses to, comments raised 
in the meeting and docket. 
‘‘(C) PERFORMANCE
REPORTS.—The re-
ports required under this section may be issued 
as a component of performance reports as re-
quired under section 9 of the Verifying Accu-
rate Leading-edge IVCT Development Act of 
2020. 
‘‘SEC. 587E. MITIGATING MEASURES. 
‘‘(a) ESTABLISHMENT OF MITIGATING MEASURES.— 
‘‘(1) ESTABLISHING, 
CHANGING, 
OR
WITH-
DRAWING.— 
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102 
‘‘(A) ESTABLISHMENT.—If the Secretary 
determines that the establishment of mitigating 
measures is necessary for either of the reasons 
described in clause (i) or (ii) of section 
587(15)(A) for any in vitro clinical test with 
the same indications for use, the Secretary may 
require that the in vitro clinical test comply 
with such mitigating measures. 
‘‘(B) 
PROCESS.—Notwithstanding 
sub-
chapter II of chapter 5 of title 5, United States 
Code, the Secretary may— 
‘‘(i) establish, change, or withdraw 
mitigating measures by— 
‘‘(I) publishing a proposed ad-
ministrative order in the Federal Reg-
ister; 
‘‘(II) providing an opportunity 
for public comment for a period of not 
less than 30 calendar days; and 
‘‘(III) after consideration of any 
comments submitted, publishing a 
final administrative order in the Fed-
eral Register; and 
‘‘(ii) may establish mitigating meas-
ures with respect to a category in a pre-
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103 
market approval order or technology cer-
tification order. 
‘‘(2) IN
VITRO
CLINICAL
TESTS
PREVIOUSLY 
APPROVED, CLEARED, OR EXEMPTED AS DEVICES.— 
‘‘(A) IN GENERAL.—Any special controls 
or restrictions applicable to an in vitro clinical 
test with the same indications for use pursuant 
to section 587(10) based on prior regulation as 
a device approved under section 515, cleared or 
exempt under section 510(k), or classified 
under section 513(f)(2), including any such spe-
cial controls or restrictions established during 
the period beginning on the date of enactment 
of the Verifying Accurate Leading-edge IVCT 
Development Act of 2020 and ending on the ef-
fective date of such Act (as described in section 
5(b) of such Act)— 
‘‘(i) shall continue to apply to such 
approved, cleared, or exempted in vitro 
clinical test after such effective date; and 
‘‘(ii) are deemed to be mitigating 
measures as of the effective date of such 
approval, clearance, or exemption. 
‘‘(B) CHANGES.—The Secretary may es-
tablish, change, or withdraw mitigating meas-
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ures for such a test or indications for use the 
procedures under paragraph (1). 
‘‘(b) DOCUMENTATION.— 
‘‘(1) TESTS
SUBJECT
TO
PREMARKET
RE-
VIEW.—The developer of an in vitro clinical test sub-
ject to premarket review under section 587B and to 
which mitigating measures apply shall— 
‘‘(A) 
in 
accordance 
with 
section 
587B(c)(2)(G)(i), submit documentation to the 
Secretary as part of the application for the test 
under subsection (c) or (d) of section 587B 
demonstrating that such mitigating measures 
have been met; 
‘‘(B) if such application is approved, main-
tain documentation demonstrating that such 
mitigating measures continue to be met fol-
lowing a test modification by the developer; and 
‘‘(C) after responding to any informal com-
munications from the Secretary, make such 
documentation available to the Secretary upon 
request or inspection. 
‘‘(2) OTHER TESTS.—The developer of an in 
vitro clinical test that is marketed within the scope 
of a technology certification order or other exemp-
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tion from premarket review under section 587B and 
to which mitigating measures apply shall— 
‘‘(A) maintain documentation in accord-
ance with the applicable quality requirements 
under section 587J demonstrating that such 
mitigating measures continue to be met fol-
lowing a test modification by the developer; 
‘‘(B) after responding to any informal 
communications from the Secretary, make such 
documentation available to the Secretary upon 
request or inspection; and 
‘‘(C) include in the performance summary 
for such test a brief description of how such 
mitigating measures are met, if applicable. 
‘‘(c) MITIGATING
MEASURES
FOR
CROSS-REF-
ERENCED TESTS.—Not later than 1 year after the imple-
mentation of the Verifying Accurate Leading-edge IVCT 
Development Act of 2020, the Secretary shall issue miti-
gating measures for cross-referenced tests. 
‘‘SEC. 587F. REGULATORY PATHWAY REDESIGNATION. 
‘‘(a) TECHNOLOGY CERTIFICATION AND EXEMPTION 
DETERMINATIONS.— 
‘‘(1) IN GENERAL.—Based on new information, 
including the establishment of mitigating measures 
under section 587E, and after considering available 
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evidence respecting tests with the same indications 
for use pursuant to section 587(10), the Secretary 
may, upon the initiative of the Secretary or upon pe-
tition of an interested person— 
‘‘(A) revoke any exemption or requirement 
in effect under this subchapter with respect to 
such indications for use; or 
‘‘(B) determine that such indications for 
use are eligible for technology certification in 
accordance with section 587D(b)(2), or are oth-
erwise exempt from premarket review under 
section 587B. 
‘‘(2) PROCESS.—Any action under paragraph 
(1) shall be made by publication of a notice of such 
proposed action on the internet website of the Food 
and Drug Administration, the consideration of com-
ments to a public docket on such proposal, and pub-
lication of a final action on such internet website 
within 60 calendar days of the close of the comment 
period posted to such public docket, notwithstanding 
subchapter II of chapter 5 of title 5, United States 
Code. 
‘‘(b) REVOCATION.—The Secretary may revoke any 
exemption with respect to such test or indications for use 
pursuant to section 587(10), if— 
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‘‘(1) new clinical information indicates that the 
exemption of an in vitro clinical test or tests from 
premarket review under section 587B or exemption 
under section 587A has a reasonable probability of 
severe adverse health consequences, including the 
absence, delay, or discontinuation of appropriate 
medical treatment. 
‘‘(2) PROCESS.—Any action under this sub-
section shall be made by publication of a notice of 
such proposed action in the Federal Register, con-
sideration of comments to a public docket on such 
proposal, and publication of a final notice in the 
Federal Register, notwithstanding subchapter II of 
chapter 5 of title 5, United States Code. 
‘‘SEC. 587G. ADVISORY COMMITTEES. 
‘‘(a) IN GENERAL.—The Secretary may establish ad-
visory committees or use advisory committee panels of ex-
perts established before the date of enactment of this sec-
tion for the purposes of providing expert scientific advice 
and making recommendations related to— 
‘‘(1) the approval of an application for an in 
vitro clinical test submitted under this subchapter, 
including for evaluating, as applicable, the analytical 
validity, clinical validity, and safety of in vitro clin-
ical tests; 
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‘‘(2) the potential effectiveness of mitigating 
measures for a determination on the applicable regu-
latory pathway under section 587F or risk evalua-
tion for an in vitro clinical test or tests; 
‘‘(3) quality requirements under section 587J 
or applying such requirements to in vitro clinical 
tests developed or imported by developers; or 
‘‘(4) such other purposes as the Secretary de-
termines appropriate. 
‘‘(b) APPOINTMENTS.— 
‘‘(1) VOTING MEMBERS.—The Secretary shall 
appoint to each committee established under sub-
section (a), as voting members, individuals who are 
qualified by training and experience to evaluate in 
vitro clinical tests referred to the committee for the 
purposes specified in subsection (a), including indi-
viduals with, to the extent feasible, scientific exper-
tise in the development, manufacture, or utilization 
of such in vitro clinical tests, laboratory operations, 
and the use of in vitro clinical tests. The Secretary 
shall designate one member of each committee to 
serve as chair. 
‘‘(2) NONVOTING MEMBERS.—In addition to the 
individuals appointed pursuant to paragraph (1), the 
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Secretary shall appoint to each committee estab-
lished under subsection (a), as nonvoting members— 
‘‘(A) a representative of consumer inter-
ests; and 
‘‘(B) a representative of interests of in 
vitro clinical test developers not directly af-
fected by the matter to be brought before the 
committee. 
‘‘(3) LIMITATION.—No individual who is in the 
regular full-time employee of the United States and 
engaged in the administration of this Act may be a 
member of any advisory committee established under 
subsection (a). 
‘‘(4) EDUCATION
AND
TRAINING.—The Sec-
retary shall, as appropriate, provide education and 
training to each new committee member before such 
member participates in a committee’s activities, in-
cluding education regarding requirements under this 
Act and related regulations of the Secretary, and the 
administrative processes and procedures related to 
committee meetings. 
‘‘(5) MEETINGS.—The Secretary shall ensure 
that scientific advisory committees meet regularly 
and at appropriate intervals so that any matter to 
be reviewed by such a committee can be presented 
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to the committee not more than 60 calendar days 
after the matter is ready for such review. Meetings 
of the committee may be held using electronic com-
munication to convene the meetings. 
‘‘(6) COMPENSATION.—Members of an advisory 
committee established under subsection (a), while at-
tending meetings or conferences or otherwise en-
gaged in the business of the advisory committee— 
‘‘(A) shall be entitled to receive compensa-
tion at rates to be fixed by the Secretary, but 
not to exceed the daily equivalent of the rate in 
effect for positions classified above level GS–15 
of the General Schedule; and 
‘‘(B) may be allowed travel expenses as au-
thorized by section 5703 of title 5, United 
States Code, for employees serving intermit-
tently in the Government service. 
‘‘(c) GUIDANCE.—The Secretary may issue guidance 
on the policies and procedures governing advisory commit-
tees established under subsection (a). 
‘‘SEC. 587H. REQUEST FOR INFORMAL FEEDBACK. 
‘‘Before submitting a premarket application or tech-
nology certification application for an in vitro clinical 
test— 
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‘‘(1) the developer of the test may submit to the 
Secretary a written request for a meeting or con-
ference to discuss and provide information relating 
to the regulation of such in vitro clinical test which 
may include— 
‘‘(A) the submission process and the type 
and amount of evidence expected to dem-
onstrate the applicable standard; 
‘‘(B) which regulatory pathway is appro-
priate for an in vitro clinical test; and 
‘‘(C) an investigation plan for an in vitro 
clinical test, including a clinical protocol; and 
‘‘(2) upon receipt of such a request, the Sec-
retary shall— 
‘‘(A) within 60 calendar days after such 
receipt, or within such time period as may be 
agreed to by the developer, meet or confer with 
the developer submitting the request; and 
‘‘(B) within 15 calendar days after such 
meeting or conference, provide to the developer 
a written record or response describing the 
issues discussed and conclusions reached in the 
meeting or conference. 
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112 
‘‘SEC. 587I. REGISTRATION AND LISTING. 
‘‘(a) REGISTRATION OF ESTABLISHMENTS FOR IN 
VITRO CLINICAL TESTS.— 
‘‘(1) IN GENERAL.—Each person described in 
subsection (b)(1), or an accredited person under sec-
tion 587P, acting on behalf of such a person, shall— 
‘‘(A) during the period beginning on Octo-
ber 1 and ending on December 31 of each year, 
register with the Secretary the name of such 
person, places of business of such person, all es-
tablishments engaged in the activities specified 
under this paragraph, the establishment reg-
istration number of each such establishment, 
and a point of contact for each such establish-
ment, including an electronic point of contact; 
and 
‘‘(B) submit an initial registration con-
taining the information required under subpara-
graph (A) not later than— 
‘‘(i) the date of implementation of this 
section if such establishment is engaged in 
any activity described in subsection (b)(1) 
on the date of enactment of this section, 
unless the Secretary establishes by guid-
ance a date later than such implementation 
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date for all or a category of such establish-
ments; or 
‘‘(ii) 30 days prior to engaging in any 
activity described in subsection (b)(1) after 
enactment of this section, if such establish-
ment is not engaged in any activity de-
scribed in this paragraph on the date of 
enactment of this section. 
‘‘(2) REGISTRATION NUMBERS.—The Secretary 
may assign a registration number to any person or 
an establishment registration number to any estab-
lishment registered in accordance with this section. 
Registration information shall be made publicly 
available by publication on the internet website 
maintained by the Food and Drug Administration, 
in accordance with subsection (d). 
‘‘(3) INSPECTION.—Every person or establish-
ment that is required to be registered with the Sec-
retary under this section shall be subject to inspec-
tion pursuant to section 704. 
‘‘(b) LISTING INFORMATION FOR IN VITRO CLINICAL 
TESTS.— 
‘‘(1) IN GENERAL.—Each person who— 
‘‘(A) is a developer, a contract manufac-
turer (including contract packaging), contract 
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sterilizer, repackager, relabeler, or distributor of 
an in vitro clinical test; and 
‘‘(B) introduces or proposes to begin the 
introduction or delivery for introduction into 
interstate commerce through an exemption 
under section 587A(f)(2)(b) or 587A(g) or 
through the filing of an application under sec-
tion 587B or 587D, 
shall submit a listing to the Secretary containing the 
information described in paragraph (2) in accord-
ance with the applicable schedule described under 
subsection (c). Such listing shall be prepared in such 
form and manner as the Secretary may specify in 
guidance. Listing information shall be submitted 
through the comprehensive test information system 
in accordance with section 587T, as appropriate. 
‘‘(2) SUBMISSIONS.—Each developer submitting 
a listing under paragraph (1) shall electronically 
submit to the comprehensive test information system 
under section 587T the following information for 
each in vitro clinical test for which such person is 
a developer in the form and manner prescribed by 
the Secretary: 
‘‘(A) Name of the establishment and its fa-
cility registration number. 
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‘‘(B) Contact information for the official 
correspondent for the listing. 
‘‘(C) Name (common name and trade 
name, if applicable) of the in vitro clinical test 
and its test listing number (when available). 
‘‘(D) CLIA certificate number for any lab-
oratory certified by the Secretary under section 
263a of title 42 that meets the requirements for 
performing high-complexity testing that is the 
developer of the in vitro clinical test, and CLIA 
certificate number for any laboratory under 
common ownership that is performing the test 
developed by such test developer. 
‘‘(E) Whether the in vitro clinical test is, 
as applicable, offered as a test approved under 
section 587B, offered under a technology cer-
tification order issued under section 587D, or 
offered as an in vitro clinical test under section 
587A. 
‘‘(F) Indications for use information under 
section 587(10). 
‘‘(G) Brief narrative description of the in 
vitro clinical test. 
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‘‘(H) A brief summary of the analytical 
and clinical performance of the in vitro clinical 
test, and as applicable, the lot release criteria. 
‘‘(I) A brief description of conformance 
with any applicable mitigating measures, re-
strictions, and standards. 
‘‘(J) Representative labeling for the in 
vitro clinical test, as appropriate. 
‘‘(K) A statement that the information 
submitted is truthful and accurate. 
‘‘(3) TEST LISTING NUMBER.—The Secretary 
may assign a test listing number to each in vitro 
clinical test that is the subject of a listing under this 
section. The process for assigning test listing num-
bers may be established through guidance, and may 
include the recognition of standards, formats, or 
conventions developed by a third-party organization. 
‘‘(4) ABBREVIATED LISTING.—A person who is 
not a developer but is otherwise required to register 
pursuant to subsection (a) shall submit an abbre-
viated listing to the Secretary containing the infor-
mation described in subparagraphs (A) through (C) 
of paragraph (2), and the name of the developer. 
The information shall be submitted in accordance 
with the applicable schedule described under sub-
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section (c). Such abbreviated listing shall be pre-
pared in such form and manner as the Secretary 
may specify in guidance. Listing information shall be 
submitted to the comprehensive test information sys-
tem in accordance with section 587T, as appro-
priate. 
‘‘(5) GRANDFATHERED TESTS.—A developer of 
an in vitro clinical test developer offering a test that 
is grandfathered under section 587A(c) shall submit 
listing information required under subparagraphs 
(A) through (I) of paragraph (2). 
‘‘(6) LOW-RISK TESTS.—A developer of a low 
risk in vitro clinical test shall notify and submit list-
ing information to the Secretary within one year of 
offering such test for clinical use. 
‘‘(7) EXEMPT
TESTS.—A developer of an in 
vitro clinical test who introduces or proposes to 
begin the introduction or delivery for introduction 
into interstate commerce pursuant to an exemption 
under section 587A may submit listing information 
under this subsection. 
‘‘(c) TIMELINES FOR SUBMISSION.— 
‘‘(1) IN GENERAL.—The timelines for submis-
sion of registration and listing under subsections (a) 
and (b) are as follows: 
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‘‘(A) For an in vitro clinical test that was 
listed as a device under section 510(j) prior to 
the date of enactment of this section, a person 
shall maintain a device listing under section 
510 until such time as the system for submit-
ting the notification information required under 
subsection (b) becomes available and thereafter 
shall submit the notification information no 
later than 1 year after the system for submit-
ting the notification under this section becomes 
available. 
‘‘(B) For an in vitro clinical test that is 
subject to the grandfathering provisions of sec-
tion 587A(c), a person shall submit the listing 
information required under subsection (b)(5) no 
later than 1 year after the system for submit-
ting the notification under this section becomes 
available. 
‘‘(C) For an in vitro clinical test that is 
not subject to subparagraph (A) or (B), a per-
son shall submit the required notification infor-
mation prior to offering, introducing, or mar-
keting the in vitro clinical test as follows: 
‘‘(i) For an in vitro clinical test that 
is not exempt from premarket approval 
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under section 587B, a person shall submit 
the required listing information no later 
than 30 business days after the date of ap-
proval of the premarket approval applica-
tion. 
‘‘(ii) For a developer who has received 
a technology certification order under sec-
tion 587D, a person shall submit the re-
quired listing information at least 30 busi-
ness days after receiving such technology 
certification order. 
‘‘(2) UPDATES.— 
‘‘(A) UPDATES
AFTER
CHANGES.—Each 
developer required to submit listing information 
under this section shall update such informa-
tion within 10 business days of any change that 
causes any previously notified information to be 
inaccurate or incomplete. 
‘‘(B) ANNUAL UPDATES.—Each developer 
required to submit listing information under 
this section shall update its information annu-
ally during the period beginning on October 1 
and ending on December 31 of each year as a 
component of the annual report submitted 
under sections 587B and 587D. 
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‘‘(d) PUBLIC AVAILABILITY OF NOTIFICATION IN-
FORMATION.— 
‘‘(1) IN
GENERAL.—Notification information 
submitted pursuant to this section shall be made 
publicly available on the website of the Food and 
Drug Administration in accordance with paragraph 
(3). 
‘‘(2) CONFIDENTIALITY.—Notification informa-
tion for an in vitro clinical test that is subject to 
premarket approval or technical certification shall 
remain confidential until such date as the in vitro 
clinical test receives the applicable premarket ap-
proval or the developer receives a technology certifi-
cation order. 
‘‘(3) EXCEPTIONS FROM PUBLIC AVAILABILITY 
REQUIREMENTS.—The registration and listing infor-
mation requirements described in subsections (a) 
and (b) shall not apply to the extent the Secretary 
determines that such information relates to— 
‘‘(A) trade secret or commercial confiden-
tial information; or 
‘‘(B) national security or countermeasures 
or is restricted from disclosure pursuant to an-
other provision of law. 
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121 
‘‘(e) SUBMISSION OF INFORMATION BY ACCREDITED 
PERSONS.—If agreed upon by the developer, the informa-
tion required under this section may be submitted by an 
accredited person under section 587P. 
‘‘SEC. 587J. TEST DESIGN AND QUALITY REQUIREMENTS. 
‘‘(a) APPLICABILITY.— 
‘‘(1) IN GENERAL.—Each developer and each 
other person required to register under section 
587I(b)(1) shall establish and maintain quality re-
quirements in accordance with the applicable re-
quirements set forth in subsection (b), except as pro-
vided in section 587A. 
‘‘(2) 
CERTIFIED
LABORATORY
REQUIRE-
MENTS.—A developer that operates a clinical labora-
tory certified by the Secretary under section 353 of 
the Public Health Service Act that— 
‘‘(A) meets the requirements for per-
forming high-complexity testing; 
‘‘(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); and 
‘‘(C) develops an in vitro clinical test or in-
dications for use that are for use only within 
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122 
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.—The Secretary may pro-
mulgate regulations to implement this section. In so 
promulgating regulations, the Secretary shall con-
sider whether and to what extent international har-
monization is appropriate. 
‘‘(b) QUALITY REQUIREMENTS.— 
‘‘(1) QUALITY
REQUIREMENTS
FOR
LABORA-
TORIES WITHOUT CLIA CERTIFICATION TO CONDUCT 
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 
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123 
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; 
‘‘(xii) labeling and packaging controls; 
‘‘(xiii) handling, storage, distribution, 
and installation; 
‘‘(xiv) records; 
‘‘(xv) servicing; and 
‘‘(xvi) statistical techniques. 
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‘‘(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 
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: 
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‘‘(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-
veloper’s in vitro clinical test in a manner 
described in section 587(6). 
‘‘(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 
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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-
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 
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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 
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.— 
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‘‘(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). Labeling in the form of a package insert shall 
also include the information in subparagraph (A) or 
(B) of paragraph (2). 
‘‘(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; 
‘‘(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 
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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 immunohematol-
ogy testing shall meet the following applicable re-
quirements set forth in part 660 of the Code of Fed-
eral Regulations (or any successor regulation), re-
lated to the labeling of blood grouping reagents, rea-
gent red blood cells, and anti-human globulin. 
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‘‘(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 
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 
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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, as it appears on the date of enactment of this 
subchapter and amended thereafter. 
‘‘(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 
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 
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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-
section (b) and subsection (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 information set forth in this paragraph, it 
need not bear the information required by subsection 
(c)(1). 
‘‘(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-
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priate for the intended users. If the labeling of such 
over-the-counter test sample collection system bears 
the information set forth in this paragraph (4)(G), 
it need not bear the information required by sub-
section (c)(1). 
‘‘(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 section, 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. 
‘‘(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. 
‘‘(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 
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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: 
‘‘(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 
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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 
‘‘(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 
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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— 
‘‘(i) is life threatening; 
‘‘(ii) results in permanent impairment 
of a body function or permanent damage 
to a body structure; or 
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‘‘(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. 
‘‘(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 
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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-
call action or stating the reasons the Secretary can-
not close the recall at that time. 
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‘‘(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-
tion, or use upon such conditions as the Secretary 
may prescribe under paragraph (2). 
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‘‘(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. 
‘‘(c) REQUIREMENTS PRIOR TO ENACTMENT.—An in 
vitro clinical test that was offered, sold, or distributed as 
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a restricted device prior to the enactment date of this sub-
chapter shall continue to comply with the applicable re-
strictions imposed under section 515 or section 520(e) 
until the effective date of restrictions issued under sub-
section (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 
under this subsection shall include a brief statement 
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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 
paragraph (1), or, in the case of a person who re-
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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 2020 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. 
‘‘(ii) Making recommendations to the 
Secretary with respect to an approval of an 
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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 
criteria under subsection (c) within such period, 
the Secretary— 
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‘‘(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 
internet website of the Food and Drug Ad-
ministration calling for applications for 
such accreditation. 
‘‘(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 2020 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— 
‘‘(i) may accredit persons under this 
subparagraph after such period; and 
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‘‘(ii) shall issue a public notice on the 
internet website of the Food and Drug Ad-
ministration calling for applications for 
such accreditation. 
‘‘(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 
made by an employee or agent of an estab-
lishment to a person accredited to conduct 
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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.— 
‘‘(A) IN
GENERAL.—The Secretary may 
provide for accreditation under this section 
through programs administered by the Food 
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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 2020, 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 
for a person unless such person meets the 
minimum qualifications required under 
subsection (c). 
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‘‘(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 internet website of the Food and 
Drug Administration a list of persons who are 
accredited under this section. Such list shall be 
updated on at least a monthly basis. The list 
shall specify the particular activity or activities 
under this section for which the person is ac-
credited. 
‘‘(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 2020, issue draft guidance specifying 
the process for submitting a request for 
each type of accreditation and reaccredita-
tion under this section, including the form 
and content of information to be submitted 
in such a request; and 
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‘‘(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 
persons continue to meet the published criteria 
for accreditation, and may modify the scope or 
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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— 
‘‘(A) not be an employee of the Federal 
Government; 
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‘‘(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 
‘‘(G) include in its request for accredita-
tion a commitment to, at the time of accredita-
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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-
trols sufficient to ensure a competent and impartial 
review. 
‘‘(d) COMPENSATION OF ACCREDITED PERSONS.— 
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‘‘(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 
is located outside the United States shall be refused ad-
mission on any of the grounds set forth in section 801(a). 
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‘‘(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 
514(c) shall be considered recognized standards under this 
section. The application of any such consensus standard 
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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 choose to seek the recommendation of 
an advisory committee under section 587G concerning a 
proposed standard either prior to or after issuance of a 
proposed order. After considering the comments and with-
in 90 days of the close of the comment period, the Sec-
retary shall issue a final order adopting the proposed 
standard, adopting a modification of the proposed stand-
ard 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. 
‘‘(b) REGULATIONS.—Not later than 2 years after 
the date of enactment of the Verifying Accurate Leading- 
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edge IVCT Development Act of 2020, 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 investigational use re-
quirements for institutional review boards and 
current processes for any analytical or clinical 
validation. 
‘‘(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; 
‘‘(iii) the need to permit changes to be 
made in the in vitro clinical test involved 
during testing conducted in accordance 
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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 
without confirmation of the diagnosis by a 
medically established means; 
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‘‘(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); 
‘‘(III) submit a listing to the Sec-
retary of such investigation; and 
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‘‘(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 
Secretary reasonably determines will enable the 
Secretary— 
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‘‘(i) to ensure compliance with the 
conditions for approval specified in para-
graph (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 OF APPROVAL.— 
‘‘(A) IN GENERAL.—An investigational use 
application with respect to significant risk tests 
shall only be approved 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’. 
‘‘(iii) Such other requirements the 
Secretary determines to be necessary for 
the protection of the public health and 
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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 of approval under this paragraph, the 
Secretary shall not impose a limit on the sam-
ple size for a significant risk in vitro clinical 
test that meets the requirements of section 
587C, as long as such test is developed within 
a laboratory that is certified to conduct 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 an investigational new drug application involving 
an in vitro clinical test shall supersede the reporting 
requirement in paragraph (2)(B), but only to the ex-
tent the requirement with respect to the investiga-
tional new drug application is duplicative of the re-
porting requirement under such paragraph. 
‘‘(5) INVESTIGATION PLAN REQUIREMENTS.— 
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‘‘(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 
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 
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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 
readily be ascertained by, the investigator 
or any other individual associated with the 
investigation, including the sponsor; 
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‘‘(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. 
‘‘(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 
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use application that meets the requirements of sub-
section (c)(2), issues an order under subsection 
(d)(1) and notifies the sponsor submitting the appli-
cation, the application shall be treated as approved 
as of such date without further action by the Sec-
retary. 
‘‘(3) DISAPPROVAL.—The Secretary may dis-
approve an investigational use application submitted 
under this subsection if the Secretary determines 
that the investigation with respect to which the ap-
plication is submitted does not conform to the re-
quirements of subsection (c)(3). A listing of such 
disapproval submitted to the sponsor with respect to 
such an application shall contain the order of dis-
approval and a complete statement of the reasons 
for the Secretary’s disapproval of the application. 
‘‘(e) WITHDRAWAL OF APPROVAL.— 
‘‘(1) IN GENERAL.—The Secretary may, by ad-
ministrative order, withdraw the approval of an ex-
emption granted under this section with respect to 
an in vitro clinical test, including an exemption 
granted based on the Secretary’s failure to act pur-
suant to subsection (d)(2), if the Secretary deter-
mines that the test does not meet the applicable con-
ditions under subsection (c)(3) for such approval. 
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‘‘(2) OPPORTUNITY TO BE HEARD.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), an order withdrawing the approval 
of an exemption granted under this section may 
be issued only after the Secretary provides the 
applicant or sponsor of the test with an oppor-
tunity 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-
tion under this subsection is in effect, procedures 
and conditions under which the changes to the test 
are allowed without the additional approval of an ap-
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plication for an exemption or the approval of a sup-
plement to such an application. 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 
‘‘(iii) are made in response to infor-
mation gathered during the course of an 
investigation; and 
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01:17 Mar 17, 2020
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H6102
pamtmann on DSKBC07HB2PROD with BILLS