H. R. 34—59 
(2) REPORT.—Not later than 5 years after the date of the 
enactment of this Act, the Secretary shall make publicly avail-
able on the Internet website of the Food and Drug Administra-
tion a report. Such report shall include, with respect to the 
qualification process under section 507 of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (a), information 
on— 
(A) the number of requests submitted, as a letter of 
intent, for qualification of a drug development tool (as 
defined in subsection (e) of such section 507); 
(B) the number of such requests accepted and deter-
mined to be eligible for submission of a qualification plan 
or full qualification package (as such terms are defined 
in subsection (e) of such section 507), respectively; 
(C) the number of such requests for which external 
scientific experts were utilized in the development of a 
qualification plan or review of a full qualification package; 
(D) the number of qualification plans and full qualifica-
tion packages, respectively, submitted to the Secretary; 
and 
(E) the drug development tools qualified through such 
qualification process, specified by type of tool, such as 
a biomarker or clinical outcome assessment (as such terms 
are defined in subsection (e) of such section 507). 
SEC. 3012. TARGETED DRUGS FOR RARE DISEASES. 
Subchapter B of chapter V of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360aa et seq.) is amended by inserting 
after section 529 the following: 
‘‘SEC. 529A. TARGETED DRUGS FOR RARE DISEASES. 
‘‘(a) PURPOSE.—The purpose of this section, through the 
approach provided for in subsection (b), is to— 
‘‘(1) facilitate the development, review, and approval of 
genetically targeted drugs and variant protein targeted drugs 
to address an unmet medical need in one or more patient 
subgroups, including subgroups of patients with different 
mutations of a gene, with respect to rare diseases or conditions 
that are serious or life-threatening; and 
‘‘(2) maximize the use of scientific tools or methods, 
including surrogate endpoints and other biomarkers, for such 
purposes. 
‘‘(b) LEVERAGING OF DATA FROM PREVIOUSLY APPROVED DRUG 
APPLICATION OR APPLICATIONS.—The Secretary may, consistent with 
applicable standards for approval under this Act or section 351(a) 
of the Public Health Service Act, allow the sponsor of an application 
under section 505(b)(1) of this Act or section 351(a) of the Public 
Health Service Act for a genetically targeted drug or a variant 
protein targeted drug to rely upon data and information— 
‘‘(1) previously developed by the same sponsor (or another 
sponsor that has provided the sponsor with a contractual right 
of reference to such data and information); and 
‘‘(2) submitted by a sponsor described in paragraph (1) 
in support of one or more previously approved applications 
that were submitted under section 505(b)(1) of this Act or 
section 351(a) of the Public Health Service Act, 
for a drug that incorporates or utilizes the same or similar geneti-
cally targeted technology as the drug or drugs that are the subject
H. R. 34—60 
of an application or applications described in paragraph (2) or 
for a variant protein targeted drug that is the same or incorporates 
or utilizes the same variant protein targeted drug, as the drug 
or drugs that are the subject of an application or applications 
described in paragraph (2). 
‘‘(c) DEFINITIONS.—For purposes of this section— 
‘‘(1) the term ‘genetically targeted drug’ means a drug 
that— 
‘‘(A) is the subject of an application under section 
505(b)(1) of this Act or section 351(a) of the Public Health 
Service Act for the treatment of a rare disease or condition 
(as such term is defined in section 526) that is serious 
or life-threatening; 
‘‘(B) may result in the modulation (including suppres-
sion, up-regulation, or activation) of the function of a gene 
or its associated gene product; and 
‘‘(C) incorporates or utilizes a genetically targeted tech-
nology; 
‘‘(2) the term ‘genetically targeted technology’ means a 
technology comprising non-replicating nucleic acid or analogous 
compounds with a common or similar chemistry that is intended 
to treat one or more patient subgroups, including subgroups 
of patients with different mutations of a gene, with the same 
disease or condition, including a disease or condition due to 
other variants in the same gene; and 
‘‘(3) the term ‘variant protein targeted drug’ means a drug 
that— 
‘‘(A) is the subject of an application under section 
505(b)(1) of this Act or section 351(a) of the Public Health 
Service Act for the treatment of a rare disease or condition 
(as such term is defined in section 526) that is serious 
or life-threatening; 
‘‘(B) modulates the function of a product of a mutated 
gene where such mutation is responsible in whole or in 
part for a given disease or condition; and 
‘‘(C) is intended to treat one or more patient subgroups, 
including subgroups of patients with different mutations 
of a gene, with the same disease or condition. 
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this section shall 
be construed to— 
‘‘(1) alter the authority of the Secretary to approve drugs 
pursuant to this Act or section 351 of the Public Health Service 
Act (as authorized prior to the date of enactment of the 21st 
Century Cures Act), including the standards of evidence, and 
applicable conditions, for approval under such applicable Act; 
or 
‘‘(2) confer any new rights, beyond those authorized under 
this Act or the Public Health Service Act prior to enactment 
of this section, with respect to the permissibility of a sponsor 
referencing information contained in another application sub-
mitted under section 505(b)(1) of this Act or section 351(a) 
of the Public Health Service Act.’’.
H. R. 34—61 
SEC. 3013. REAUTHORIZATION OF PROGRAM TO ENCOURAGE TREAT-
MENTS FOR RARE PEDIATRIC DISEASES. 
(a) IN GENERAL.—Section 529(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360ff(b)) is amended by striking para-
graph (5) and inserting the following: 
‘‘(5) TERMINATION OF AUTHORITY.—The Secretary may not 
award any priority review vouchers under paragraph (1) after 
September 30, 2020, unless the rare pediatric disease product 
application— 
‘‘(A) is for a drug that, not later than September 30, 
2020, is designated under subsection (d) as a drug for 
a rare pediatric disease; and 
‘‘(B) is, not later than September 30, 2022, approved 
under section 505(b)(1) of this Act or section 351(a) of 
the Public Health Service Act.’’. 
(b) REPORT.—The Advancing Hope Act of 2016 (Public Law 
114–229) is amended by striking section 3. 
SEC. 3014. GAO STUDY OF PRIORITY REVIEW VOUCHER PROGRAMS. 
(a) STUDY.—The Comptroller General of the United States 
(referred to in this section as the ‘‘Comptroller General’’) shall 
conduct a study addressing the effectiveness and overall impact 
of the following priority review voucher programs, including any 
such programs amended or established by this Act: 
(1) The neglected tropical disease priority review voucher 
program under section 524 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360n). 
(2) The rare pediatric disease priority review voucher pro-
gram under section 529 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360ff). 
(3) The medical countermeasure priority review voucher 
program under section 565A of the Federal Food, Drug, and 
Cosmetic Act, as added by section 3086. 
(b) ISSUANCE OF REPORT.—Not later than January 31, 2020, 
the Comptroller General shall submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives a report 
containing the results of the study under subsection (a). 
(c) CONTENTS OF REPORTS.—The report submitted under sub-
section (b) shall address— 
(1) for each drug for which a priority review voucher has 
been awarded as of initiation of the study— 
(A) the indications for which the drug is approved 
under section 505(c) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(c)), pursuant to an application 
under section 505(b)(1) of such Act, or licensed under sec-
tion 351(a) of the Public Health Service Act (42 U.S.C. 
262(a)); 
(B) whether, and to what extent, the voucher impacted 
the sponsor’s decision to develop the drug; and 
(C) whether, and to what extent, the approval or licen-
sure of the drug, as applicable and appropriate— 
(i) addressed a global unmet need related to the 
treatment or prevention of a neglected tropical disease, 
including whether the sponsor of a drug coordinated 
with international development organizations;
H. R. 34—62 
(ii) addressed an unmet need related to the treat-
ment of a rare pediatric disease; or 
(iii) affected the Nation’s preparedness against a 
chemical, biological, radiological, or nuclear threat, 
including naturally occurring threats; 
(2) for each drug for which a priority review voucher has 
been used— 
(A) the indications for which such drug is approved 
under section 505(c) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(c)), pursuant to an application 
under section 505(b)(1) of such Act, or licensed under sec-
tion 351(a) of the Public Health Service Act (42 U.S.C. 
262); 
(B) the value of the voucher, if transferred; and 
(C) the length of time between the date on which 
the voucher was awarded and the date on which the 
voucher was used; and 
(3) an analysis of the priority review voucher programs 
described in subsection (a), including— 
(A) the resources used by the Food and Drug Adminis-
tration in reviewing drugs for which vouchers were used, 
including the effect of the programs on the Food and Drug 
Administration’s review of drugs for which priority review 
vouchers were not awarded or used; 
(B) whether any improvements to such programs are 
necessary to appropriately target incentives for the develop-
ment of drugs that would likely not otherwise be developed, 
or developed in as timely a manner, and, as applicable 
and appropriate— 
(i) address global unmet needs related to the treat-
ment or prevention of neglected tropical diseases, 
including in countries in which neglected tropical dis-
eases are endemic; or 
(ii) address unmet needs related to the treatment 
of rare pediatric diseases; and 
(C) whether the sunset of the rare pediatric disease 
program and medical countermeasure program has had 
an impact on the program, including any potential unin-
tended consequences. 
(d) PROTECTION OF NATIONAL SECURITY.—The Comptroller Gen-
eral shall conduct the study and issue reports under this section 
in a manner that does not compromise national security. 
SEC. 3015. AMENDMENTS TO THE ORPHAN DRUG GRANTS. 
Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is 
amended— 
(1) in subsection (a), by striking paragraph (1) and inserting 
the following: ‘‘(1) defraying the costs of developing drugs for 
rare 
diseases 
or 
conditions, 
including 
qualified 
testing 
expenses,’’; and 
(2) in subsection (b)(1)— 
(A) in subparagraph (A)(ii), by striking ‘‘and’’ after 
the semicolon; 
(B) in subparagraph (B), by striking the period and 
inserting ‘‘; and’’; and 
(C) by adding at the end the following:
H. R. 34—63 
‘‘(C) prospectively planned and designed observational 
studies and other analyses conducted to assist in the under-
standing of the natural history of a rare disease or condition 
and in the development of a therapy, including studies 
and analyses to— 
‘‘(i) develop or validate a drug development tool 
related to a rare disease or condition; or 
‘‘(ii) understand the full spectrum of the disease 
manifestations, including describing genotypic and 
phenotypic variability and identifying and defining dis-
tinct subpopulations affected by a rare disease or condi-
tion.’’. 
SEC. 3016. GRANTS FOR STUDYING CONTINUOUS DRUG MANUFAC-
TURING. 
(a) IN GENERAL.—The Secretary of Health and Human Services 
may award grants to institutions of higher education and nonprofit 
organizations for the purpose of studying and recommending 
improvements to the process of continuous manufacturing of drugs 
and biological products and similar innovative monitoring and con-
trol techniques. 
(b) DEFINITIONS.—In this section— 
(1) the term ‘‘drug’’ has the meaning given such term 
in section 201 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321); 
(2) the term ‘‘biological product’’ has the meaning given 
such term in section 351(i) of the Public Health Service Act 
(42 U.S.C. 262(i)); and 
(3) the term ‘‘institution of higher education’’ has the 
meaning given such term in section 101(a) of the Higher Edu-
cation Act of 1965 (20 U.S.C. 1001(a)). 
Subtitle C—Modern Trial Design and 
Evidence Development 
SEC. 3021. NOVEL CLINICAL TRIAL DESIGNS. 
(a) PROPOSALS FOR USE OF NOVEL CLINICAL TRIAL DESIGNS 
FOR DRUGS AND BIOLOGICAL PRODUCTS.—For purposes of assisting 
sponsors in incorporating complex adaptive and other novel trial 
designs into proposed clinical protocols and applications for new 
drugs under section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355) and biological products under section 351 of 
the Public Health Service Act (42 U.S.C. 262), the Secretary of 
Health and Human Services (referred to in this section as the 
‘‘Secretary’’) shall conduct a public meeting and issue guidance 
in accordance with subsection (b). 
(b) GUIDANCE ADDRESSING USE
OF NOVEL CLINICAL TRIAL 
DESIGNS.— 
(1) IN
GENERAL.—The Secretary, acting through the 
Commissioner of Food and Drugs, shall update or issue guid-
ance addressing the use of complex adaptive and other novel 
trial design in the development and regulatory review and 
approval or licensure for drugs and biological products. 
(2) CONTENTS.—The guidance under paragraph (1) shall 
address—
H. R. 34—64 
(A) the use of complex adaptive and other novel trial 
designs, including how such clinical trials proposed or sub-
mitted help to satisfy the substantial evidence standard 
under section 505(d) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(d)); 
(B) how sponsors may obtain feedback from the Sec-
retary on technical issues related to modeling and simula-
tions prior to— 
(i) completion of such modeling or simulations; 
or 
(ii) the submission of resulting information to the 
Secretary; 
(C) the types of quantitative and qualitative informa-
tion that should be submitted for review; and 
(D) recommended analysis methodologies. 
(3) PUBLIC MEETING.—Prior to updating or issuing the guid-
ance required by paragraph (1), the Secretary shall consult 
with stakeholders, including representatives of regulated 
industry, academia, patient advocacy organizations, consumer 
groups, and disease research foundations, through a public 
meeting to be held not later than 18 months after the date 
of enactment of this Act. 
(4) TIMING.—The Secretary shall update or issue a draft 
version of the guidance required by paragraph (1) not later 
than 18 months after the date of the public meeting required 
by paragraph (3) and finalize such guidance not later than 
1 year after the date on which the public comment period 
for the draft guidance closes. 
SEC. 3022. REAL WORLD EVIDENCE. 
Chapter V of the Federal Food, Drug, and Cosmetic Act is 
amended by inserting after section 505E (21 U.S.C. 355f) the fol-
lowing: 
‘‘SEC. 505F. UTILIZING REAL WORLD EVIDENCE. 
‘‘(a) IN GENERAL.—The Secretary shall establish a program 
to evaluate the potential use of real world evidence— 
‘‘(1) to help to support the approval of a new indication 
for a drug approved under section 505(c); and 
‘‘(2) to help to support or satisfy postapproval study require-
ments. 
‘‘(b) REAL WORLD EVIDENCE DEFINED.—In this section, the term 
‘real world evidence’ means data regarding the usage, or the poten-
tial benefits or risks, of a drug derived from sources other than 
randomized clinical trials. 
‘‘(c) PROGRAM FRAMEWORK.— 
‘‘(1) IN GENERAL.—Not later than 2 years after the date 
of enactment of the 21st Century Cures Act, the Secretary 
shall establish a draft framework for implementation of the 
program under this section. 
‘‘(2) CONTENTS
OF
FRAMEWORK.—The framework shall 
include information describing— 
‘‘(A) the sources of real world evidence, including 
ongoing safety surveillance, observational studies, reg-
istries, claims, and patient-centered outcomes research 
activities; 
‘‘(B) the gaps in data collection activities;
H. R. 34—65 
‘‘(C) the standards and methodologies for collection 
and analysis of real world evidence; and 
‘‘(D) the priority areas, remaining challenges, and 
potential pilot opportunities that the program established 
under this section will address. 
‘‘(3) CONSULTATION.— 
‘‘(A) IN GENERAL.—In developing the program frame-
work under this subsection, the Secretary shall consult 
with regulated industry, academia, medical professional 
organizations, representatives of patient advocacy organiza-
tions, consumer organizations, disease research founda-
tions, and other interested parties. 
‘‘(B) PROCESS.—The consultation under subparagraph 
(A) may be carried out through approaches such as— 
‘‘(i) a public-private partnership with the entities 
described in such subparagraph in which the Secretary 
may participate; 
‘‘(ii) a contract, grant, or other arrangement, as 
the Secretary determines appropriate, with such a 
partnership or an independent research organization; 
or 
‘‘(iii) public workshops with the entities described 
in such subparagraph. 
‘‘(d) PROGRAM IMPLEMENTATION.—The Secretary shall, not later 
than 2 years after the date of enactment of the 21st Century 
Cures Act and in accordance with the framework established under 
subsection (c), implement the program to evaluate the potential 
use of real world evidence. 
‘‘(e) GUIDANCE FOR INDUSTRY.—The Secretary shall— 
‘‘(1) utilize the program established under subsection (a), 
its activities, and any subsequent pilots or written reports, 
to inform a guidance for industry on— 
‘‘(A) the circumstances under which sponsors of drugs 
and the Secretary may rely on real world evidence for 
the purposes described in paragraphs (1) and (2) of sub-
section (a); and 
‘‘(B) the appropriate standards and methodologies for 
collection and analysis of real world evidence submitted 
for such purposes; 
‘‘(2) not later than 5 years after the date of enactment 
of the 21st Century Cures Act, issue draft guidance for industry 
as described in paragraph (1); and 
‘‘(3) not later than 18 months after the close of the public 
comment period for the draft guidance described in paragraph 
(2), issue revised draft guidance or final guidance. 
‘‘(f) RULE OF CONSTRUCTION.— 
‘‘(1) IN
GENERAL.—Subject to paragraph (2), nothing in 
this section prohibits the Secretary from using real world evi-
dence for purposes not specified in this section, provided the 
Secretary determines that sufficient basis exists for any such 
nonspecified use. 
‘‘(2) 
STANDARDS
OF
EVIDENCE
AND
SECRETARY’S 
AUTHORITY.—This section shall not be construed to alter— 
‘‘(A) the standards of evidence under— 
‘‘(i) subsection (c) or (d) of section 505, including 
the substantial evidence standard in such subsection 
(d); or
H. R. 34—66 
‘‘(ii) section 351(a) of the Public Health Service 
Act; or 
‘‘(B) the Secretary’s authority to require postapproval 
studies or clinical trials, or the standards of evidence under 
which studies or trials are evaluated.’’. 
SEC. 3023. PROTECTION OF HUMAN RESEARCH SUBJECTS. 
(a) IN GENERAL.—In order to simplify and facilitate compliance 
by researchers with applicable regulations for the protection of 
human subjects in research, the Secretary of Health and Human 
Services (referred to in this section as the ‘‘Secretary’’) shall, to 
the extent practicable and consistent with other statutory provi-
sions, harmonize differences between the HHS Human Subject 
Regulations and the FDA Human Subject Regulations in accordance 
with subsection (b). 
(b) AVOIDING REGULATORY DUPLICATION
AND UNNECESSARY 
DELAYS.—The Secretary shall, as appropriate— 
(1) make such modifications to the provisions of the HHS 
Human Subject Regulations, the FDA Human Subject Regula-
tions, and the vulnerable populations rules as may be nec-
essary— 
(A) to reduce regulatory duplication and unnecessary 
delays; 
(B) to modernize such provisions in the context of 
multisite and cooperative research projects; and 
(C) to protect vulnerable populations, incorporate local 
considerations, 
and 
support 
community 
engagement 
through mechanisms such as consultation with local 
researchers and human research protection programs, in 
a manner consistent with subparagraph (B); and 
(2) ensure that human subject research that is subject 
to the HHS Human Subject Regulations and to the FDA Human 
Subject Regulations may— 
(A) use joint or shared review; 
(B) rely upon the review of— 
(i) an independent institutional review board; or 
(ii) an institutional review board of an entity other 
than the sponsor of the research; or 
(C) use similar arrangements to avoid duplication of 
effort. 
(c) CONSULTATION.—In harmonizing or modifying regulations 
or guidance under this section, the Secretary shall consult with 
stakeholders (including researchers, academic organizations, hos-
pitals, institutional research boards, pharmaceutical, biotechnology, 
and medical device developers, clinical research organizations, 
patient groups, and others). 
(d) TIMING.—The Secretary shall complete the harmonization 
described in subsection (a) not later than 3 years after the date 
of enactment of this Act. 
(e) PROGRESS REPORT.—Not later than 2 years after the date 
of enactment of this Act, the Secretary shall submit to Congress 
a report on the progress made toward completing such harmoni-
zation. 
(f) DEFINITIONS.— 
(1) HUMAN SUBJECT REGULATIONS.—In this section: 
(A) FDA HUMAN
SUBJECT
REGULATIONS.—The term 
‘‘FDA Human Subject Regulations’’ means the provisions
H. R. 34—67 
of parts 50, 56, 312, and 812 of title 21, Code of Federal 
Regulations (or any successor regulations). 
(B) HHS HUMAN
SUBJECT
REGULATIONS.—The term 
‘‘HHS Human Subject Regulations’’ means the provisions 
of subpart A of part 46 of title 45, Code of Federal Regula-
tions (or any successor regulations). 
(C) 
VULNERABLE
POPULATION
RULES.—The 
term 
‘‘vulnerable population rules’’ means— 
(i) except in the case of research described in clause 
(ii), the provisions of subparts B through D of part 
46, Code of Federal Regulations (or any successor regu-
lations); and 
(ii) in the case of research that is subject to FDA 
Human Subject Regulations, the provisions applicable 
to vulnerable populations under part 56 of title 21, 
Code of Federal Regulations (or any successor regula-
tions) and subpart D of part 50 of such title 21 (or 
any successor regulations). 
(2) INSTITUTIONAL REVIEW BOARD DEFINED.—In this section, 
the term ‘‘institutional review board’’ has the meaning that 
applies to the term ‘‘institutional review board’’ under the HHS 
Human Subject Regulations. 
SEC. 3024. INFORMED CONSENT WAIVER OR ALTERATION FOR CLIN-
ICAL INVESTIGATIONS. 
(a) DEVICES.—Section 520(g)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(g)(3)) is amended— 
(1) in subparagraph (D), by striking ‘‘except where subject 
to such conditions as the Secretary may prescribe, the investi-
gator’’ and inserting the following: ‘‘except where, subject to 
such conditions as the Secretary may prescribe— 
‘‘(i) the proposed clinical testing poses no more than 
minimal risk to the human subject and includes appro-
priate safeguards to protect the rights, safety, and welfare 
of the human subject; or 
‘‘(ii) the investigator’’; and 
(2) in the matter following subparagraph (D), by striking 
‘‘subparagraph (D)’’ and inserting ‘‘subparagraph (D)(ii)’’. 
(b) DRUGS.—Section 505(i)(4) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(i)(4)) is amended by striking ‘‘except 
where it is not feasible or it is contrary to the best interests 
of such human beings’’ and inserting ‘‘except where it is not feasible, 
it is contrary to the best interests of such human beings, or the 
proposed clinical testing poses no more than minimal risk to such 
human beings and includes appropriate safeguards as prescribed 
to protect the rights, safety, and welfare of such human beings’’. 
Subtitle D—Patient Access to Therapies 
and Information 
SEC. 3031. SUMMARY LEVEL REVIEW. 
(a) FFDCA.—Section 505(c) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(c)) is amended by adding at the end 
the following: 
‘‘(5)(A) The Secretary may rely upon qualified data summaries 
to support the approval of a supplemental application, with respect
H. R. 34—68 
to a qualified indication for a drug, submitted under subsection 
(b), if such supplemental application complies with subparagraph 
(B). 
‘‘(B) A supplemental application is eligible for review as 
described in subparagraph (A) only if— 
‘‘(i) there is existing data available and acceptable to the 
Secretary demonstrating the safety of the drug; and 
‘‘(ii) all data used to develop the qualified data summaries 
are submitted to the Secretary as part of the supplemental 
application. 
‘‘(C) The Secretary shall post on the Internet website of the 
Food and Drug Administration and update annually— 
‘‘(i) the number of applications reviewed solely under 
subparagraph (A) or section 351(a)(2)(E) of the Public Health 
Service Act; 
‘‘(ii) the average time for completion of review under 
subparagraph (A) or section 351(a)(2)(E) of the Public Health 
Service Act; 
‘‘(iii) the average time for review of supplemental applica-
tions where the Secretary did not use review flexibility under 
subparagraph (A) or section 351(a)(2)(E) of the Public Health 
Service Act; and 
‘‘(iv) the number of applications reviewed under subpara-
graph (A) or section 351(a)(2)(E) of the Public Health Service 
Act for which the Secretary made use of full data sets in 
addition to the qualified data summary. 
‘‘(D) In this paragraph— 
‘‘(i) the term ‘qualified indication’ means an indication for 
a drug that the Secretary determines to be appropriate for 
summary level review under this paragraph; and 
‘‘(ii) the term ‘qualified data summary’ means a summary 
of clinical data that demonstrates the safety and effectiveness 
of a drug with respect to a qualified indication.’’. 
(b) PHSA.—Section 351(a)(2) of the Public Health Service Act 
(42 U.S.C. 262(a)(2)) is amended by adding at the end the following: 
‘‘(E)(i) The Secretary may rely upon qualified data summaries 
to support the approval of a supplemental application, with respect 
to a qualified indication for a drug, submitted under this subsection, 
if such supplemental application complies with the requirements 
of subparagraph (B) of section 505(c)(5) of the Federal Food, Drug, 
and Cosmetic Act. 
‘‘(ii) In this subparagraph, the terms ‘qualified indication’ and 
‘qualified data summary’ have the meanings given such terms in 
section 505(c)(5) of the Federal Food, Drug, and Cosmetic Act.’’. 
SEC. 3032. EXPANDED ACCESS POLICY. 
Chapter V of the Federal Food, Drug, and Cosmetic Act is 
amended by inserting after section 561 (21 U.S.C. 360bbb) the 
following: 
‘‘SEC. 561A. EXPANDED ACCESS POLICY REQUIRED FOR INVESTIGA-
TIONAL DRUGS. 
‘‘(a) IN GENERAL.—The manufacturer or distributor of one or 
more investigational drugs for the diagnosis, monitoring, or treat-
ment of one or more serious diseases or conditions shall make 
available the policy of the manufacturer or distributor on evaluating 
and responding to requests submitted under section 561(b) for provi-
sion of such a drug.
H. R. 34—69 
‘‘(b) PUBLIC AVAILABILITY OF EXPANDED ACCESS POLICY.—The 
policies under subsection (a) shall be made public and readily 
available, such as by posting such policies on a publicly available 
Internet website. Such policies may be generally applicable to all 
investigational drugs of such manufacturer or distributor. 
‘‘(c) CONTENT OF POLICY.—A policy described in subsection (a) 
shall include— 
‘‘(1) contact information for the manufacturer or distributor 
to facilitate communication about requests described in sub-
section (a); 
‘‘(2) procedures for making such requests; 
‘‘(3) the general criteria the manufacturer or distributor 
will use to evaluate such requests for individual patients, and 
for responses to such requests; 
‘‘(4) the length of time the manufacturer or distributor 
anticipates will be necessary to acknowledge receipt of such 
requests; and 
‘‘(5) a hyperlink or other reference to the clinical trial 
record containing information about the expanded access for 
such drug that is required under section 402(j)(2)(A)(ii)(II)(gg) 
of the Public Health Service Act. 
‘‘(d) NO GUARANTEE OF ACCESS.—The posting of policies by 
manufacturers and distributors under subsection (a) shall not serve 
as a guarantee of access to any specific investigational drug by 
any individual patient. 
‘‘(e) REVISED POLICY.—Nothing in this section shall prevent 
a manufacturer or distributor from revising a policy required under 
this section at any time. 
‘‘(f) APPLICATION.—This section shall apply to a manufacturer 
or distributor with respect to an investigational drug beginning 
on the later of— 
‘‘(1) the date that is 60 calendar days after the date of 
enactment of the 21st Century Cures Act; or 
‘‘(2) the first initiation of a phase 2 or phase 3 study 
(as such terms are defined in section 312.21(b) and (c) of title 
21, Code of Federal Regulations (or any successor regulations)) 
with respect to such investigational drug.’’. 
SEC. 3033. ACCELERATED APPROVAL FOR REGENERATIVE ADVANCED 
THERAPIES. 
(a) IN GENERAL.—Section 506 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356) is amended— 
(1) by transferring subsection (e) (relating to construction) 
so that it appears before subsection (f) (relating to awareness 
efforts); and 
(2) by adding at the end the following: 
‘‘(g) REGENERATIVE ADVANCED THERAPY.— 
‘‘(1) IN GENERAL.—The Secretary, at the request of the 
sponsor of a drug, shall facilitate an efficient development 
program for, and expedite review of, such drug if the drug 
qualifies as a regenerative advanced therapy under the criteria 
described in paragraph (2). 
‘‘(2) CRITERIA.—A drug is eligible for designation as a regen-
erative advanced therapy under this subsection if— 
‘‘(A) the drug is a regenerative medicine therapy (as 
defined in paragraph (8));
H. R. 34—70 
‘‘(B) the drug is intended to treat, modify, reverse, 
or cure a serious or life-threatening disease or condition; 
and 
‘‘(C) preliminary clinical evidence indicates that the 
drug has the potential to address unmet medical needs 
for such a disease or condition. 
‘‘(3) REQUEST FOR DESIGNATION.—The sponsor of a drug 
may request the Secretary to designate the drug as a regenera-
tive advanced therapy concurrently with, or at any time after, 
submission of an application for the investigation of the drug 
under section 505(i) of this Act or section 351(a)(3) of the 
Public Health Service Act. 
‘‘(4) DESIGNATION.—Not later than 60 calendar days after 
the receipt of a request under paragraph (3), the Secretary 
shall determine whether the drug that is the subject of the 
request meets the criteria described in paragraph (2). If the 
Secretary determines that the drug meets the criteria, the 
Secretary shall designate the drug as a regenerative advanced 
therapy and shall take such actions as are appropriate under 
paragraph (1). If the Secretary determines that a drug does 
not meet the criteria for such designation, the Secretary shall 
include with the determination a written description of the 
rationale for such determination. 
‘‘(5) ACTIONS.—The sponsor of a regenerative advanced 
therapy shall be eligible for the actions to expedite development 
and review of such therapy under subsection (a)(3)(B), including 
early interactions to discuss any potential surrogate or inter-
mediate endpoint to be used to support the accelerated approval 
of an application for the product under subsection (c). 
‘‘(6) ACCESS
TO
EXPEDITED
APPROVAL
PATHWAYS.—An 
application for a regenerative advanced therapy under section 
505(b)(1) of this Act or section 351(a) of the Public Health 
Service Act may be— 
‘‘(A) eligible for priority review, as described in the 
Manual of Policies and Procedures of the Food and Drug 
Administration and goals identified in the letters described 
in section 101(b) of the Prescription Drug User Fee Amend-
ments of 2012; and 
‘‘(B) eligible for accelerated approval under subsection 
(c), as agreed upon pursuant to subsection (a)(3)(B), 
through, as appropriate— 
‘‘(i) surrogate or intermediate endpoints reasonably 
likely to predict long-term clinical benefit; or 
‘‘(ii) reliance upon data obtained from a meaningful 
number of sites, including through expansion to addi-
tional sites, as appropriate. 
‘‘(7) POSTAPPROVAL
REQUIREMENTS.—The sponsor of a 
regenerative advanced therapy that is granted accelerated 
approval and is subject to the postapproval requirements under 
subsection (c) may, as appropriate, fulfill such requirements, 
as the Secretary may require, through— 
‘‘(A) the submission of clinical evidence, clinical studies, 
patient registries, or other sources of real world evidence, 
such as electronic health records; 
‘‘(B) the collection of larger confirmatory data sets, 
as agreed upon pursuant to subsection (a)(3)(B); or
H. R. 34—71 
‘‘(C) postapproval monitoring of all patients treated 
with such therapy prior to approval of the therapy. 
‘‘(8) DEFINITION.—For purposes of this section, the term 
‘regenerative medicine therapy’ includes cell therapy, thera-
peutic tissue engineering products, human cell and tissue prod-
ucts, and combination products using any such therapies or 
products, except for those regulated solely under section 361 
of the Public Health Service Act and part 1271 of title 21, 
Code of Federal Regulations.’’. 
(b) RULE OF CONSTRUCTION.—Nothing in this section and the 
amendments made by this section shall be construed to alter the 
authority of the Secretary of Health and Human Services— 
(1) to approve drugs pursuant to the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.) and section 351 
of the Public Health Service Act (42 U.S.C. 262) as authorized 
prior to the date of enactment of the 21st Century Cures 
Act, including the standards of evidence, and applicable condi-
tions, for approval under such Acts; or 
(2) to alter the authority of the Secretary to require post-
approval studies pursuant to such Acts, as authorized prior 
to the date of enactment of the 21st Century Cures Act. 
(c) CONFORMING AMENDMENT.—Section 506(e)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356(e)(1)) is amended 
by inserting ‘‘and the 21st Century Cures Act’’ after ‘‘Food and 
Drug Administration Safety and Innovation Act’’. 
SEC. 3034. GUIDANCE REGARDING DEVICES USED IN THE RECOVERY, 
ISOLATION, OR DELIVERY OF REGENERATIVE ADVANCED 
THERAPIES. 
(a) DRAFT GUIDANCE.—Not later than 1 year after the date 
of enactment of the 21st Century Cures Act, the Secretary of Health 
and Human Services, acting through the Commissioner of Food 
and Drugs, shall issue draft guidance clarifying how, in the context 
of regenerative advanced therapies, the Secretary will evaluate 
devices used in the recovery, isolation, or delivery of regenerative 
advanced therapies. In doing so, the Secretary shall specifically 
address— 
(1) how the Food and Drug Administration intends to sim-
plify and streamline regulatory requirements for combination 
device and cell or tissue products; 
(2) what, if any, intended uses or specific attributes would 
result in a device used with a regenerative therapy product 
to be classified as a class III device; 
(3) when the Food and Drug Administration considers it 
is necessary, if ever, for the intended use of a device to be 
limited to a specific intended use with only one particular 
type of cell; and 
(4) application of the least burdensome approach to dem-
onstrate how a device may be used with more than one cell 
type. 
(b) FINAL GUIDANCE.—Not later than 12 months after the close 
of the period for public comment on the draft guidance under 
subsection (a), the Secretary of Health and Human Services shall 
finalize such guidance. 
SEC. 3035. REPORT ON REGENERATIVE ADVANCED THERAPIES. 
(a) REPORT TO CONGRESS.—Before March 1 of each calendar 
year, the Secretary of Health and Human Services shall, with
H. R. 34—72 
respect to the previous calendar year, submit a report to the Com-
mittee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives on— 
(1) the number and type of applications for approval of 
regenerative advanced therapies filed, approved or licensed as 
applicable, withdrawn, or denied; and 
(2) how many of such applications or therapies, as 
applicable, were granted accelerated approval or priority 
review. 
(b) REGENERATIVE ADVANCED THERAPY.—In this section, the 
term ‘‘regenerative advanced therapy’’ has the meaning given such 
term in section 506(g) of the Federal Food, Drug, and Cosmetic 
Act, as added by section 3033 of this Act. 
SEC. 3036. STANDARDS FOR REGENERATIVE MEDICINE AND REGEN-
ERATIVE ADVANCED THERAPIES. 
Subchapter A of chapter V of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 506F the following: 
‘‘SEC. 506G. STANDARDS FOR REGENERATIVE MEDICINE AND REGEN-
ERATIVE ADVANCED THERAPIES. 
‘‘(a) IN GENERAL.—Not later than 2 years after the date of 
enactment of the 21st Century Cures Act, the Secretary, in consulta-
tion with the National Institute of Standards and Technology and 
stakeholders (including regenerative medicine and advanced thera-
pies manufacturers and clinical trial sponsors, contract manufactur-
ers, academic institutions, practicing clinicians, regenerative medi-
cine and advanced therapies industry organizations, and standard 
setting organizations), shall facilitate an effort to coordinate and 
prioritize the development of standards and consensus definition 
of terms, through a public process, to support, through regulatory 
predictability, the development, evaluation, and review of regenera-
tive medicine therapies and regenerative advanced therapies, 
including with respect to the manufacturing processes and controls 
of such products. 
‘‘(b) ACTIVITIES.— 
‘‘(1) IN GENERAL.—In carrying out this section, the Sec-
retary shall continue to— 
‘‘(A) identity opportunities to help advance the develop-
ment of regenerative medicine therapies and regenerative 
advanced therapies; 
‘‘(B) identify opportunities for the development of lab-
oratory regulatory science research and documentary 
standards that the Secretary determines would help sup-
port the development, evaluation, and review of regenera-
tive medicine therapies and regenerative advanced thera-
pies through regulatory predictability; and 
‘‘(C) work with stakeholders, such as those described 
in subsection (a), as appropriate, in the development of 
such standards. 
‘‘(2) REGULATIONS AND GUIDANCE.—Not later than 1 year 
after the development of standards as described in subsection 
(a), the Secretary shall review relevant regulations and guid-
ance and, through a public process, update such regulations 
and guidance as the Secretary determines appropriate.
H. R. 34—73 
‘‘(c) DEFINITIONS.—For purposes of this section, the terms 
‘regenerative medicine therapy’ and ‘regenerative advanced therapy’ 
have the meanings given such terms in section 506(g).’’. 
SEC. 3037. HEALTH CARE ECONOMIC INFORMATION. 
Section 502(a) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 352(a)) is amended— 
(1) by striking ‘‘(a) If its’’ and inserting ‘‘(a)(1) If its’’; 
(2) by striking ‘‘a formulary committee, or other similar 
entity, in the course of the committee or the entity carrying 
out its responsibilities for the selection of drugs for managed 
care or other similar organizations’’ and inserting ‘‘a payor, 
formulary committee, or other similar entity with knowledge 
and expertise in the area of health care economic analysis, 
carrying out its responsibilities for the selection of drugs for 
coverage or reimbursement’’; 
(3) by striking ‘‘directly relates’’ and inserting ‘‘relates’’; 
(4) by striking ‘‘and is based on competent and reliable 
scientific evidence. The requirements set forth in section 505(a) 
or in section 351(a) of the Public Health Service Act shall 
not apply to health care economic information provided to such 
a committee or entity in accordance with this paragraph’’ and 
inserting ‘‘, is based on competent and reliable scientific evi-
dence, and includes, where applicable, a conspicuous and promi-
nent statement describing any material differences between 
the health care economic information and the labeling approved 
for the drug under section 505 or under section 351 of the 
Public Health Service Act. The requirements set forth in section 
505(a) or in subsections (a) and (k) of section 351 of the Public 
Health Service Act shall not apply to health care economic 
information provided to such a payor, committee, or entity 
in accordance with this paragraph’’; and 
(5) by striking ‘‘In this paragraph, the term’’ and all that 
follows and inserting the following: 
‘‘(2)(A) For purposes of this paragraph, the term ‘health care 
economic information’ means any analysis (including the clinical 
data, inputs, clinical or other assumptions, methods, results, and 
other components underlying or comprising the analysis) that 
identifies, measures, or describes the economic consequences, which 
may be based on the separate or aggregated clinical consequences 
of the represented health outcomes, of the use of a drug. Such 
analysis may be comparative to the use of another drug, to another 
health care intervention, or to no intervention. 
‘‘(B) Such term does not include any analysis that relates only 
to an indication that is not approved under section 505 or under 
section 351 of the Public Health Service Act for such drug.’’. 
SEC. 3038. COMBINATION PRODUCT INNOVATION. 
(a) IN GENERAL.—Section 503(g) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 353(g)) is amended— 
(1) by striking paragraph (3); 
(2) by redesignating paragraph (2) as paragraph (7); 
(3) by redesignating paragraphs (4) and (5) as paragraphs 
(8) and (9), respectively; 
(4) by striking ‘‘(g)(1)’’ and all that follows through the 
end of paragraph (1) and inserting the following:
H. R. 34—74 
‘‘(g)(1)(A) The Secretary shall, in accordance with this sub-
section, assign a primary agency center to regulate products that 
constitute a combination of a drug, device, or biological product. 
‘‘(B) The Secretary shall conduct the premarket review of any 
combination product under a single application, whenever appro-
priate. 
‘‘(C) For purposes of this subsection, the term ‘primary mode 
of action’ means the single mode of action of a combination product 
expected to make the greatest contribution to the overall intended 
therapeutic effects of the combination product. 
‘‘(D) The Secretary shall determine the primary mode of action 
of the combination product. If the Secretary determines that the 
primary mode of action is that of— 
‘‘(i) a drug (other than a biological product), the agency 
center charged with premarket review of drugs shall have 
primary jurisdiction; 
‘‘(ii) a device, the agency center charged with premarket 
review of devices shall have primary jurisdiction; or 
‘‘(iii) a biological product, the agency center charged with 
premarket review of biological products shall have primary 
jurisdiction. 
‘‘(E) In determining the primary mode of action of a combination 
product, the Secretary shall not determine that the primary mode 
of action is that of a drug or biological product solely because 
the combination product has any chemical action within or on 
the human body. 
‘‘(F) If a sponsor of a combination product disagrees with the 
determination under subparagraph (D)— 
‘‘(i) such sponsor may request, and the Secretary shall 
provide, a substantive rationale to such sponsor that references 
scientific evidence provided by the sponsor and any other sci-
entific evidence relied upon by the Secretary to support such 
determination; and 
‘‘(ii)(I) the sponsor of the combination product may propose 
one or more studies (which may be nonclinical, clinical, or 
both) to establish the relevance, if any, of the chemical action 
in achieving the primary mode of action of such product; 
‘‘(II) if the sponsor proposes any such studies, the Secretary 
and the sponsor of such product shall collaborate and seek 
to reach agreement, within a reasonable time of such proposal, 
not to exceed 90 calendar days, on the design of such studies; 
and 
‘‘(III) if an agreement is reached under subclause (II) and 
the sponsor conducts one or more of such studies, the Secretary 
shall consider the data resulting from any such study when 
reevaluating the determination of the primary mode of action 
of such product, and unless and until such reevaluation has 
occurred and the Secretary issues a new determination, the 
determination of the Secretary under subparagraph (D) shall 
remain in effect. 
‘‘(2)(A)(i) To establish clarity and certainty for the sponsor, 
the sponsor of a combination product may request a meeting on 
such combination product. If the Secretary concludes that a deter-
mination of the primary mode of action pursuant to paragraph 
(1)(D) is necessary, the sponsor may request such meeting only 
after the Secretary makes such determination. If the sponsor sub-
mits a written meeting request, the Secretary shall, not later than
H. R. 34—75 
75 calendar days after receiving such request, meet with the sponsor 
of such combination product. 
‘‘(ii) A meeting under clause (i) may— 
‘‘(I) address the standards and requirements for market 
approval or clearance of the combination product; 
‘‘(II) address other issues relevant to such combination 
product, such as requirements related to postmarket modifica-
tion of such combination product and good manufacturing prac-
tices applicable to such combination product; and 
‘‘(III) identify elements under subclauses (I) and (II) that 
may be more appropriate for discussion and agreement with 
the Secretary at a later date given that scientific or other 
information is not available, or agreement is otherwise not 
feasible regarding such elements, at the time a request for 
such meeting is made. 
‘‘(iii) Any agreement under this subparagraph shall be in 
writing and made part of the administrative record by the Secretary. 
‘‘(iv) Any such agreement shall remain in effect, except— 
‘‘(I) upon the written agreement of the Secretary and the 
sponsor or applicant; or 
‘‘(II) pursuant to a decision by the director of the reviewing 
division of the primary agency center, or a person more senior 
than such director, in consultation with consulting centers and 
the Office, as appropriate, that an issue essential to deter-
mining whether the standard for market clearance or other 
applicable standard under this Act or the Public Health Service 
Act applicable to the combination product has been identified 
since the agreement was reached, or that deviating from the 
agreement is otherwise justifiable based on scientific evidence, 
for public health reasons. 
‘‘(3) For purposes of conducting the premarket review of a 
combination product that contains an approved constituent part 
described in paragraph (4), the Secretary may require that the 
sponsor of such combination product submit to the Secretary only 
data or information that the Secretary determines is necessary 
to meet the standard for clearance or approval, as applicable, under 
this Act or the Public Health Service Act, including any incremental 
risks and benefits posed by such combination product, using a 
risk-based approach and taking into account any prior finding of 
safety and effectiveness or substantial equivalence for the approved 
constituent part relied upon by the applicant in accordance with 
paragraph (5). 
‘‘(4) For purposes of paragraph (3), an approved constituent 
part is— 
‘‘(A) a drug constituent part of a combination product being 
reviewed in a single application or request under section 515, 
510(k), or 513(f)(2) (submitted in accordance with paragraph 
(5)), that is an approved drug, provided such application or 
request complies with paragraph (5); 
‘‘(B) a device constituent part approved under section 515 
that is referenced by the sponsor and that is available for 
use by the Secretary under section 520(h)(4); or 
‘‘(C) any constituent part that was previously approved, 
cleared, or classified under section 505, 510(k), 513(f)(2), or 
515 of this Act for which the sponsor has a right of reference 
or any constituent part that is a nonprescription drug, as 
defined in section 760(a)(2).
H. R. 34—76 
‘‘(5)(A) If an application is submitted under section 515 or 
510(k) or a request is submitted under section 513(f)(2), consistent 
with any determination made under paragraph (1)(D), for a com-
bination product containing as a constituent part an approved 
drug— 
‘‘(i) the application or request shall include the certification 
or statement described in section 505(b)(2); and 
‘‘(ii) the applicant or requester shall provide notice as 
described in section 505(b)(3). 
‘‘(B) For purposes of this paragraph and paragraph (4), the 
term ‘approved drug’ means an active ingredient— 
‘‘(i) that was in an application previously approved under 
section 505(c); 
‘‘(ii) where such application is relied upon by the applicant 
submitting the application or request described in subpara-
graph (A); 
‘‘(iii) for which full reports of investigations that have been 
made to show whether such drug is safe for use and whether 
such drug is effective in use were not conducted by or for 
the applicant submitting the application or request described 
in subparagraph (A); and 
‘‘(iv) for which the applicant submitting the application 
or request described in subparagraph (A) has not obtained 
a right of reference or use from the person by or for whom 
the investigations described in clause (iii) were conducted. 
‘‘(C) The following provisions shall apply with respect to an 
application or request described in subparagraph (A) to the same 
extent and in the same manner as if such application or request 
were an application described in section 505(b)(2) that referenced 
the approved drug: 
‘‘(i) Subparagraphs (A), (B), (C), and (D) of section 505(c)(3). 
‘‘(ii) Clauses (ii), (iii), and (iv) of section 505(c)(3)(E). 
‘‘(iii) Subsections (b) and (c) of section 505A. 
‘‘(iv) Section 505E(a). 
‘‘(v) Section 527(a). 
‘‘(D) Notwithstanding any other provision of this subsection, 
an application or request for classification for a combination product 
described in subparagraph (A) shall be considered an application 
submitted 
under 
section 
505(b)(2) 
for 
purposes 
of 
section 
271(e)(2)(A) of title 35, United States Code. 
‘‘(6) Nothing in this subsection shall be construed as prohibiting 
a sponsor from submitting separate applications for the constituent 
parts of a combination product, unless the Secretary determines 
that a single application is necessary.’’; 
(5) in paragraph (8) (as redesignated by paragraph (3))— 
(A) in subparagraph (C)— 
(i) by amending clause (i) to read as follows: 
‘‘(i) In carrying out this subsection, the Office shall help to 
ensure timely and effective premarket review that involves more 
than one agency center by coordinating such reviews, overseeing 
the timeliness of such reviews, and overseeing the alignment of 
feedback regarding such reviews.’’; 
(ii) in clause (ii), by inserting ‘‘and alignment’’ 
after ‘‘the timeliness’’ each place it appears; and 
(iii) by adding at the end the following new clauses: 
‘‘(iii) The Office shall ensure that, with respect to a combination 
product, a designated person or persons in the primary agency
H. R. 34—77 
center is the primary point or points of contact for the sponsor 
of such combination product. The Office shall also coordinate 
communications to and from any consulting center involved in 
such premarket review, if requested by such primary agency center 
or any such consulting center. Agency communications and commit-
ments, to the extent consistent with other provisions of law and 
the requirements of all affected agency centers, from the primary 
agency center shall be considered as communication from the Sec-
retary on behalf of all agency centers involved in the review. 
‘‘(iv) The Office shall, with respect to the premarket review 
of a combination product— 
‘‘(I) ensure that any meeting between the Secretary and 
the sponsor of such product is attended by each agency center 
involved in the review, as appropriate; 
‘‘(II) ensure that each consulting agency center has com-
pleted its premarket review and provided the results of such 
review to the primary agency center in a timely manner; and 
‘‘(III) ensure that each consulting center follows the guid-
ance described in clause (vi) and advises, as appropriate, on 
other relevant regulations, guidances, and policies. 
‘‘(v) In seeking agency action with respect to a combination 
product, the sponsor of such product— 
‘‘(I) shall identify the product as a combination product; 
and 
‘‘(II) may request in writing the participation of representa-
tives of the Office in meetings related to such combination 
product, or to have the Office otherwise engage on such regu-
latory matters concerning the combination product. 
‘‘(vi) Not later than 4 years after the date of enactment of 
the 21st Century Cures Act, and after a public comment period 
of not less than 60 calendar days, the Secretary shall issue a 
final guidance that describes— 
‘‘(I) the structured process for managing pre-submission 
interactions with sponsors developing combination products; 
‘‘(II) the best practices for ensuring that the feedback in 
such pre-submission interactions represents the Agency’s best 
advice based on the information provided during such pre- 
submission interactions; 
‘‘(III) the information that is required to be submitted 
with a meeting request under paragraph (2), how such meetings 
relate to other types of meetings in the Food and Drug Adminis-
tration, and the form and content of any agreement reached 
through a meeting under such paragraph (2);’’; and 
(B) in subparagraph (G)— 
(i) in the matter preceding clause (i), by inserting 
‘‘(except with respect to clause (iv), beginning not later 
than one year after the date of the enactment of the 
21st Century Cures Act)’’ after ‘‘enactment of this para-
graph’’; 
(ii) in clause (ii), by striking ‘‘and’’ at the end; 
(iii) in clause (iii), by striking the period at the 
end and inserting ‘‘; and’’; and 
(iv) by adding at the end the following new clause: 
‘‘(iv) identifying the percentage of combination products 
for which a dispute resolution, with respect to premarket 
review, was requested by the combination product’s sponsor.’’; 
and
H. R. 34—78 
(6) in paragraph (9) (as redesignated by paragraph (3))— 
(A) in subparagraph (C)— 
(i) in clause (i), by striking the comma at the 
end and inserting a semicolon; 
(ii) in clause (ii), by striking ‘‘, and’’ at the end 
and inserting a semicolon; 
(iii) in clause (iii), by striking the period at the 
end and inserting ‘‘; and’’; and 
(iv) by adding at the end the following: 
‘‘(iv) 
de 
novo 
classification 
under 
section 
513(a)(1).’’; and 
(B) by adding at the end the following: 
‘‘(D) The terms ‘premarket review’ and ‘reviews’ include 
all activities of the Food and Drug Administration conducted 
prior to approval or clearance of an application, notification, 
or request for classification submitted under section 505, 510(k), 
513(f)(2), 515, or 520 of this Act or under section 351 of the 
Public Health Service Act, including with respect to investiga-
tional use of the product.’’. 
(b) INFORMATION FOR APPROVAL OF COMBINATION PRODUCTS.— 
Section 520(h)(4) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360j(h)(4)) is amended— 
(1) in subparagraph (A), by striking ‘‘Any information’’ 
and inserting ‘‘Subject to subparagraph (C), any information’’; 
and 
(2) by adding at the end the following new subparagraph: 
‘‘(C) No information contained in an application for premarket 
approval filed with the Secretary pursuant to section 515(c) may 
be used to approve or clear any application submitted under section 
515 or 510(k) or to classify a product under section 513(f)(2) for 
a combination product containing as a constituent part an approved 
drug (as defined in section 503(g)(5)(B)) unless— 
‘‘(i) the application includes the certification or statement 
referenced in section 503(g)(5)(A); 
‘‘(ii) the applicant provides notice as described in section 
503(g)(5)(A); and 
‘‘(iii) the Secretary’s approval of such application is subject 
to the provisions in section 503(g)(5)(C).’’. 
(c) VARIATIONS FROM CGMP STREAMLINED APPROACH.—Not 
later than 18 months after the date of enactment of this Act, 
the Secretary of Health and Human Services (referred to in this 
subsection as the ‘‘Secretary’’) shall identify types of combination 
products and manufacturing processes with respect to which the 
Secretary proposes that good manufacturing processes may be 
adopted that vary from the requirements set forth in section 4.4 
of title 21, Code of Federal Regulations (or any successor regula-
tions) or that the Secretary proposes can satisfy the requirements 
in section 4.4 through alternative or streamlined mechanisms. The 
Secretary shall identify such types, variations from such require-
ments, and such mechanisms, in a proposed list published in the 
Federal Register. After a public comment period regarding the 
appropriate good manufacturing practices for such types, the Sec-
retary shall publish a final list in the Federal Register, notwith-
standing section 553 of title 5, United States Code. The Secretary 
shall evaluate such types, variations, and mechanisms using a 
risk-based approach. The Secretary shall periodically review such 
final list.
H. R. 34—79 
Subtitle E—Antimicrobial Innovation and 
Stewardship 
SEC. 3041. ANTIMICROBIAL RESISTANCE MONITORING. 
(a) IN GENERAL.—Section 319E of the Public Health Service 
Act (42 U.S.C. 247d–5) is amended— 
(1) by redesignating subsections (f) and (g) as subsections 
(l) and (m), respectively; and 
(2) by inserting after subsection (e), the following: 
‘‘(f) MONITORING AT FEDERAL HEALTH CARE FACILITIES.—The 
Secretary shall encourage reporting on aggregate antimicrobial drug 
use and antimicrobial resistance to antimicrobial drugs and the 
implementation of antimicrobial stewardship programs by health 
care facilities of the Department of Defense, the Department of 
Veterans Affairs, and the Indian Health Service and shall provide 
technical assistance to the Secretary of Defense and the Secretary 
of Veterans Affairs, as appropriate and upon request. 
‘‘(g) REPORT ON ANTIMICROBIAL RESISTANCE IN HUMANS AND 
USE OF ANTIMICROBIAL DRUGS.—Not later than 1 year after the 
date of enactment of the 21st Century Cures Act, and annually 
thereafter, the Secretary shall prepare and make publicly available 
data and information concerning— 
‘‘(1) aggregate national and regional trends of antimicrobial 
resistance in humans to antimicrobial drugs, including such 
drugs approved under section 506(h) of the Federal Food, Drug, 
and Cosmetic Act; 
‘‘(2) antimicrobial stewardship, which may include sum-
maries of State efforts to address antimicrobial resistance in 
humans to antimicrobial drugs and antimicrobial stewardship; 
and 
‘‘(3) coordination between the Director of the Centers for 
Disease Control and Prevention and the Commissioner of Food 
and Drugs with respect to the monitoring of— 
‘‘(A) any applicable resistance under paragraph (1); 
and 
‘‘(B) drugs approved under section 506(h) of the Federal 
Food, Drug, and Cosmetic Act. 
‘‘(h) INFORMATION RELATED TO ANTIMICROBIAL STEWARDSHIP 
PROGRAMS.—The Secretary shall, as appropriate, disseminate guid-
ance, educational materials, or other appropriate materials related 
to the development and implementation of evidence-based anti-
microbial stewardship programs or practices at health care facilities, 
such as nursing homes and other long-term care facilities, ambula-
tory surgical centers, dialysis centers, outpatient clinics, and hos-
pitals, including community and rural hospitals. 
‘‘(i) SUPPORTING STATE-BASED ACTIVITIES TO COMBAT ANTI-
MICROBIAL RESISTANCE.—The Secretary shall continue to work with 
State and local public health departments on statewide or regional 
programs related to antimicrobial resistance. Such efforts may 
include activities to related to— 
‘‘(1) identifying patterns of bacterial and fungal resistance 
in humans to antimicrobial drugs; 
‘‘(2) preventing the spread of bacterial and fungal infections 
that are resistant to antimicrobial drugs; and 
‘‘(3) promoting antimicrobial stewardship.
H. R. 34—80 
‘‘(j) ANTIMICROBIAL
RESISTANCE
AND
STEWARDSHIP
ACTIVI-
TIES.— 
‘‘(1) IN GENERAL.—For the purposes of supporting steward-
ship activities, examining changes in antimicrobial resistance, 
and evaluating the effectiveness of section 506(h) of the Federal 
Food, Drug, and Cosmetic Act, the Secretary shall— 
‘‘(A) provide a mechanism for facilities to report data 
related to their antimicrobial stewardship activities 
(including analyzing the outcomes of such activities); and 
‘‘(B) evaluate— 
‘‘(i) antimicrobial resistance data using a standard-
ized approach; and 
‘‘(ii) trends in the utilization of drugs approved 
under such section 506(h) with respect to patient popu-
lations. 
‘‘(2) USE OF SYSTEMS.—The Secretary shall use available 
systems, including the National Healthcare Safety Network 
or other systems identified by the Secretary, to fulfill the 
requirements or conduct activities under this section. 
‘‘(k) ANTIMICROBIAL.—For purposes of subsections (f) through 
(j), the term ‘antimicrobial’ includes any antibacterial or antifungal 
drugs, and may include drugs that eliminate or inhibit the growth 
of other microorganisms, as appropriate.’’. 
(b) AVAILABILITY OF DATA.—The Secretary shall make the data 
collected pursuant to this subsection public. Nothing in this sub-
section shall be construed as authorizing the Secretary to disclose 
any information that is a trade secret or confidential information 
subject to section 552(b)(4) of title 5, United States Code, or section 
1905 of title 18, United States Code. 
SEC. 3042. LIMITED POPULATION PATHWAY. 
Section 506 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 356), as amended by section 3033, is further amended by 
adding at the end the following: 
‘‘(h) LIMITED POPULATION PATHWAY FOR ANTIBACTERIAL AND 
ANTIFUNGAL DRUGS.— 
‘‘(1) IN
GENERAL.—The Secretary may approve an anti-
bacterial or antifungal drug, alone or in combination with one 
or more other drugs, as a limited population drug pursuant 
to this subsection only if— 
‘‘(A) the drug is intended to treat a serious or life- 
threatening infection in a limited population of patients 
with unmet needs; 
‘‘(B) the standards for approval under section 505(c) 
and (d), or the standards for licensure under section 351 
of the Public Health Service Act, as applicable, are met; 
and 
‘‘(C) the Secretary receives a written request from the 
sponsor to approve the drug as a limited population drug 
pursuant to this subsection. 
‘‘(2) BENEFIT-RISK CONSIDERATION.—The Secretary’s deter-
mination of safety and effectiveness of an antibacterial or 
antifungal drug shall reflect the benefit-risk profile of such 
drug in the intended limited population, taking into account 
the severity, rarity, or prevalence of the infection the drug 
is intended to treat and the availability or lack of alternative 
treatment in such limited population. Such drug may be
H. R. 34—81 
approved under this subsection notwithstanding a lack of evi-
dence to fully establish a favorable benefit-risk profile in a 
population that is broader than the intended limited population. 
‘‘(3) ADDITIONAL REQUIREMENTS.—A drug approved under 
this subsection shall be subject to the following requirements, 
in addition to any other applicable requirements of this Act: 
‘‘(A) LABELING.—To indicate that the safety and 
effectiveness of a drug approved under this subsection has 
been demonstrated only with respect to a limited popu-
lation— 
‘‘(i) all labeling and advertising of an antibacterial 
or antifungal drug approved under this subsection shall 
contain the statement ‘Limited Population’ in a promi-
nent manner and adjacent to, and not more prominent 
than— 
‘‘(I) the proprietary name of such drug, if any; 
or 
‘‘(II) if there is no proprietary name, the estab-
lished name of the drug, if any, as defined in 
section 503(e)(3), or, in the case of a drug that 
is a biological product, the proper name, as defined 
by regulation; and 
‘‘(ii) the prescribing information for the drug 
required by section 201.57 of title 21, Code of Federal 
Regulations (or any successor regulation) shall also 
include the following statement: ‘This drug is indicated 
for use in a limited and specific population of patients.’. 
‘‘(B) PROMOTIONAL MATERIAL.—The sponsor of an anti-
bacterial or antifungal drug subject to this subsection shall 
submit to the Secretary copies of all promotional materials 
related to such drug at least 30 calendar days prior to 
dissemination of the materials. 
‘‘(4) OTHER PROGRAMS.—A sponsor of a drug that seeks 
approval of a drug under this subsection may also seek designa-
tion or approval, as applicable, of such drug under other 
applicable sections or subsections of this Act or the Public 
Health Service Act. 
‘‘(5) GUIDANCE.—Not later than 18 months after the date 
of enactment of the 21st Century Cures Act, the Secretary 
shall issue draft guidance describing criteria, processes, and 
other general considerations for demonstrating the safety and 
effectiveness of limited population antibacterial and antifungal 
drugs. The Secretary shall publish final guidance within 18 
months of the close of the public comment period on such 
draft guidance. The Secretary may approve antibacterial and 
antifungal drugs under this subsection prior to issuing guidance 
under this paragraph. 
‘‘(6) ADVICE.—The Secretary shall provide prompt advice 
to the sponsor of a drug for which the sponsor seeks approval 
under this subsection to enable the sponsor to plan a develop-
ment program to obtain the necessary data for such approval, 
and to conduct any additional studies that would be required 
to gain approval of such drug for use in a broader population. 
‘‘(7) TERMINATION OF LIMITATIONS.—If, after approval of 
a drug under this subsection, the Secretary approves a broader 
indication for such drug under section 505(b) or section 351(a) 
of the Public Health Service Act, the Secretary may remove
H. R. 34—82 
any postmarketing conditions, including requirements with 
respect to labeling and review of promotional materials under 
paragraph (3), applicable to the approval of the drug under 
this subsection. 
‘‘(8) RULES OF CONSTRUCTION.—Nothing in this subsection 
shall be construed to alter the authority of the Secretary to 
approve drugs pursuant to this Act or section 351 of the Public 
Health Service Act, including the standards of evidence and 
applicable conditions for approval under such Acts, the stand-
ards of approval of a drug under such Acts, or to alter the 
authority of the Secretary to monitor drugs pursuant to such 
Acts. 
‘‘(9) REPORTING AND ACCOUNTABILITY.— 
‘‘(A) BIENNIAL REPORTING.—The Secretary shall report 
to Congress not less often than once every 2 years on 
the number of requests for approval, and the number of 
approvals, of an antibacterial or antifungal drug under 
this subsection. 
‘‘(B) GAO REPORT.—Not later than December 2021, 
the Comptroller General of the United States shall submit 
to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Edu-
cation, Labor and Pensions of the Senate a report on the 
coordination of activities required under section 319E of 
the Public Health Service Act. Such report shall include 
a review of such activities, and the extent to which the 
use of the pathway established under this subsection has 
streamlined premarket approval for antibacterial or 
antifungal drugs for limited populations, if such pathway 
has functioned as intended, if such pathway has helped 
provide for safe and effective treatment for patients, if 
such premarket approval would be appropriate for other 
categories of drugs, and if the authorities under this sub-
section have affected antibacterial or antifungal resist-
ance.’’. 
SEC. 3043. PRESCRIBING AUTHORITY. 
Nothing in this subtitle, or an amendment made by this sub-
title, shall be construed to restrict the prescribing of antimicrobial 
drugs or other products, including drugs approved under subsection 
(h) of section 506 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 356) (as added by section 3042), by health care profes-
sionals, or to limit the practice of health care. 
SEC. 3044. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR 
MICROORGANISMS; 
ANTIMICROBIAL 
SUSCEPTIBILITY 
TESTING DEVICES. 
(a) IN GENERAL.—Subchapter A of chapter V of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended 
by inserting after section 511 the following: 
‘‘SEC. 511A. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR 
MICROORGANISMS. 
‘‘(a) PURPOSE; IDENTIFICATION OF CRITERIA.— 
‘‘(1) PURPOSE.—The purpose of this section is to clarify 
the Secretary’s authority to— 
‘‘(A) efficiently update susceptibility test interpretive 
criteria for antimicrobial drugs when necessary for public
H. R. 34—83 
health, due to, among other things, the constant evolution 
of microorganisms that leads to the development of resist-
ance to drugs that have been effective in decreasing mor-
bidity and mortality for patients, which warrants unique 
management of antimicrobial drugs that is inappropriate 
for most other drugs in order to delay or prevent the 
development of further resistance to existing therapies; 
‘‘(B) provide for public notice of the availability of recog-
nized interpretive criteria and interpretive criteria stand-
ards; and 
‘‘(C) clear under section 510(k), classify under section 
513(f)(2), or approve under section 515, antimicrobial 
susceptibility testing devices utilizing updated, recognized 
susceptibility test interpretive criteria to characterize the 
in vitro susceptibility of particular bacteria, fungi, or other 
microorganisms, as applicable, to antimicrobial drugs. 
‘‘(2) IDENTIFICATION
OF
CRITERIA.—The Secretary shall 
identify appropriate susceptibility test interpretive criteria with 
respect to antimicrobial drugs— 
‘‘(A) if such criteria are available on the date of 
approval of the drug under section 505 of this Act or 
licensure of the drug under section 351 of the Public Health 
Service Act (as applicable), upon such approval or licensure; 
or 
‘‘(B) if such criteria are unavailable on such date, on 
the date on which such criteria are available for such 
drug. 
‘‘(3) BASES
FOR
INITIAL
IDENTIFICATION.—The Secretary 
shall identify appropriate susceptibility test interpretive criteria 
under paragraph (2), based on the Secretary’s review of, to 
the extent available and relevant— 
‘‘(A) preclinical and clinical data, including pharmaco-
kinetic, pharmacodynamic, and epidemiological data; 
‘‘(B) the relationship of susceptibility test interpretive 
criteria to morbidity and mortality associated with the 
disease or condition for which such drug is used; and 
‘‘(C) such other evidence and information as the Sec-
retary considers appropriate. 
‘‘(b) SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA WEBSITE.— 
‘‘(1) IN GENERAL.—Not later than 1 year after the date 
of the enactment of the 21st Century Cures Act, the Secretary 
shall establish, and maintain thereafter, on the website of 
the Food and Drug Administration, a dedicated website that 
contains a list of any appropriate new or updated susceptibility 
test interpretive criteria standards and interpretive criteria 
in accordance with paragraph (2) (referred to in this section 
as the ‘Interpretive Criteria Website’). 
‘‘(2) LISTING OF SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA 
STANDARDS AND INTERPRETIVE CRITERIA.— 
‘‘(A) IN GENERAL.—The list described in paragraph (1) 
shall consist of any new or updated susceptibility test 
interpretive criteria standards that are— 
‘‘(i) established by a nationally or internationally 
recognized standard development organization that— 
‘‘(I) establishes and maintains procedures to 
address potential conflicts of interest and ensure 
transparent decisionmaking;
H. R. 34—84 
‘‘(II) holds open meetings to ensure that there 
is an opportunity for public input by interested 
parties, and establishes and maintains processes 
to ensure that such input is considered in decision-
making; and 
‘‘(III) permits its standards to be made publicly 
available, through the National Library of Medi-
cine or another similar source acceptable to the 
Secretary; and 
‘‘(ii) recognized in whole, or in part, by the Sec-
retary under subsection (c). 
‘‘(B) OTHER LIST.—The Interpretive Criteria Website 
shall, in addition to the list described in subparagraph 
(A), include a list of interpretive criteria, if any, that the 
Secretary has determined to be appropriate with respect 
to legally marketed antimicrobial drugs, where— 
‘‘(i) the Secretary does not recognize, in whole or 
in part, an interpretive criteria standard described 
under subparagraph (A) otherwise applicable to such 
a drug; 
‘‘(ii) the Secretary withdraws under subsection 
(c)(1)(A) recognition of a standard, in whole or in part, 
otherwise applicable to such a drug; 
‘‘(iii) the Secretary approves an application under 
section 505 of this Act or section 351 of the Public 
Health Service Act, as applicable, with respect to mar-
keting of such a drug for which there are no relevant 
interpretive criteria included in a standard recognized 
by the Secretary under subsection (c); or 
‘‘(iv) because the characteristics of such a drug 
differ from other drugs with the same active ingredient, 
the interpretive criteria with respect to such drug— 
‘‘(I) differ from otherwise applicable interpre-
tive criteria included in a standard listed under 
subparagraph (A) or interpretive criteria otherwise 
listed under this subparagraph; and 
‘‘(II) are determined by the Secretary to be 
appropriate for the drug. 
‘‘(C) REQUIRED STATEMENTS.—The Interpretive Criteria 
Website shall include statements conveying— 
‘‘(i) that the website provides information about 
the in vitro susceptibility of bacteria, fungi, or other 
microorganisms, as applicable to a certain drug (or 
drugs); 
‘‘(ii) that— 
‘‘(I) the safety and efficacy of such drugs in 
treating clinical infections due to such bacteria, 
fungi, or other microorganisms, as applicable, may 
or may not have been established in adequate 
and well-controlled clinical trials in order for the 
susceptibility information described in clause (i) 
to be included on the website; and 
‘‘(II) the clinical significance of such suscepti-
bility information in such instances is unknown; 
‘‘(iii) that the approved product labeling for specific 
drugs provides the uses for which the Secretary has 
approved the product; and
H. R. 34—85 
‘‘(iv) any other information that the Secretary 
determines appropriate to adequately convey the 
meaning of the data supporting the recognition or 
listing of susceptibility test interpretive criteria stand-
ards or susceptibility test interpretive criteria included 
on the website. 
‘‘(3) NOTICE.—Not later than the date on which the 
Interpretive Criteria Website is established, the Secretary shall 
publish a notice of that establishment in the Federal Register. 
‘‘(4) INAPPLICABILITY
OF
MISBRANDING
PROVISION.—The 
inclusion in the approved labeling of an antimicrobial drug 
of a reference or hyperlink to the Interpretive Criteria Website, 
in and of itself, shall not cause the drug to be misbranded 
in violation of section 502. 
‘‘(5) TRADE
SECRETS
AND
CONFIDENTIAL
INFORMATION.— 
Nothing in this section shall be construed as authorizing the 
Secretary to disclose any information that is a trade secret 
or confidential information subject to section 552(b)(4) of title 
5, United States Code. 
‘‘(c) RECOGNITION OF SUSCEPTIBILITY TEST INTERPRETIVE CRI-
TERIA.— 
‘‘(1) EVALUATION AND PUBLICATION.— 
‘‘(A) IN
GENERAL.—Beginning on the date of the 
establishment of the Interpretive Criteria Website, and 
at least every 6 months thereafter, the Secretary shall— 
‘‘(i) evaluate any appropriate new or updated 
susceptibility test interpretive criteria standards estab-
lished by a nationally or internationally recognized 
standard development organization described in sub-
section (b)(2)(A)(i); and 
‘‘(ii) publish on the public website of the Food 
and Drug Administration a notice— 
‘‘(I) withdrawing recognition of any different 
susceptibility test interpretive criteria standard, 
in whole or in part; 
‘‘(II) recognizing the new or updated stand-
ards; 
‘‘(III) recognizing one or more parts of the 
new or updated interpretive criteria specified in 
such a standard and declining to recognize the 
remainder of such standard; and 
‘‘(IV) making any necessary updates to the 
lists under subsection (b)(2). 
‘‘(B) UPON APPROVAL OF A DRUG.—Upon the approval 
of an initial or supplemental application for an anti-
microbial drug under section 505 of this Act or section 
351 of the Public Health Service Act, as applicable, where 
such approval is based on susceptibility test interpretive 
criteria which differ from those contained in a standard 
recognized, or from those otherwise listed, by the Secretary 
pursuant to this subsection, or for which there are no 
relevant interpretive criteria standards recognized, or 
interpretive criteria otherwise listed, by the Secretary 
pursuant to this subsection, the Secretary shall update 
the lists under subparagraphs (A) and (B) of subsection 
(b)(2) to include the susceptibility test interpretive criteria 
upon which such approval was based.
H. R. 34—86 
‘‘(2) BASES FOR UPDATING INTERPRETIVE CRITERIA STAND-
ARDS.—In evaluating new or updated susceptibility test 
interpretive criteria standards under paragraph (1)(A), the Sec-
retary may consider— 
‘‘(A) the Secretary’s determination that such a standard 
is not applicable to a particular drug because the character-
istics of the drug differ from other drugs with the same 
active ingredient; 
‘‘(B) information provided by interested third parties, 
including public comment on the annual compilation of 
notices published under paragraph (3); 
‘‘(C) any bases used to identify susceptibility test 
interpretive criteria under subsection (a)(2); and 
‘‘(D) such other information or factors as the Secretary 
determines appropriate. 
‘‘(3) ANNUAL
COMPILATION
OF
NOTICES.—Each year, the 
Secretary shall compile the notices published under paragraph 
(1)(A) and publish such compilation in the Federal Register 
and provide for public comment. If the Secretary receives com-
ments, the Secretary shall review such comments and, if the 
Secretary determines appropriate, update pursuant to this sub-
section susceptibility test interpretive criteria standards or cri-
teria— 
‘‘(A) recognized by the Secretary under this subsection; 
or 
‘‘(B) otherwise listed on the Interpretive Criteria 
Website under subsection (b)(2). 
‘‘(4) RELATION TO SECTION 514(c).—Any susceptibility test 
interpretive standard recognized under this subsection or any 
criteria otherwise listed under subsection (b)(2)(B) shall be 
deemed to be recognized as a standard by the Secretary under 
section 514(c)(1). 
‘‘(5) VOLUNTARY USE OF INTERPRETIVE CRITERIA.—Nothing 
in this section prohibits a person from seeking approval or 
clearance of a drug or device, or changes to the drug or the 
device, on the basis of susceptibility test interpretive criteria 
which differ from those contained in a standard recognized, 
or from those otherwise listed, by the Secretary pursuant to 
subsection (b)(2). 
‘‘(d) ANTIMICROBIAL DRUG LABELING.— 
‘‘(1) DRUGS
MARKETED
PRIOR
TO
ESTABLISHMENT
OF 
INTERPRETIVE CRITERIA WEBSITE.— 
‘‘(A) IN GENERAL.—With respect to an antimicrobial 
drug lawfully introduced or delivered for introduction into 
interstate commerce for commercial distribution before the 
establishment of the Interpretive Criteria Website, a holder 
of an approved application under section 505 of this Act 
or section 351 of the Public Health Service Act, as 
applicable, for each such drug, not later than 1 year after 
establishment 
of 
the 
Interpretive 
Criteria 
Website 
described in subsection (b)(1), shall remove susceptibility 
test interpretive criteria, if any, and related information 
from the approved drug labeling and replace it with a 
reference to the Interpretive Criteria Website. 
‘‘(B) 
LABELING
CHANGES.—The 
labeling 
changes 
required by this section shall be considered a minor change
H. R. 34—87 
under section 314.70 of title 21, Code of Federal Regula-
tions (or any successor regulations) that may be imple-
mented through documentation in the next applicable 
annual report. 
‘‘(2) DRUGS MARKETED SUBSEQUENT TO ESTABLISHMENT OF 
INTERPRETIVE CRITERIA WEBSITE.—With respect to antimicrobial 
drugs approved on or after the date of the establishment of 
the Interpretive Criteria Website described in subsection (b)(1), 
the labeling for such a drug shall include, in lieu of suscepti-
bility test interpretive criteria and related information, a ref-
erence to such Website. 
‘‘(e) SPECIAL CONDITION
FOR MARKETING
OF ANTIMICROBIAL 
SUSCEPTIBILITY TESTING DEVICES.— 
‘‘(1) IN GENERAL.—Notwithstanding sections 501, 502, 505, 
510, 513, and 515, if the conditions specified in paragraph 
(2) are met (in addition to other applicable provisions under 
this chapter) with respect to an antimicrobial susceptibility 
testing device described in subsection (f)(1), the Secretary may 
authorize the marketing of such device for a use described 
in such subsection. 
‘‘(2) CONDITIONS APPLICABLE TO ANTIMICROBIAL SUSCEPTI-
BILITY TESTING DEVICES.—The conditions specified in this para-
graph are the following: 
‘‘(A) The device is used to make a determination of 
susceptibility using susceptibility test interpretive criteria 
that are— 
‘‘(i) included in a standard recognized by the Sec-
retary under subsection (c); or 
‘‘(ii) otherwise listed on the Interpretive Criteria 
Website under subsection (b)(2). 
‘‘(B) The labeling of such device includes statements 
conveying— 
‘‘(i) that the device provides information about the 
in vitro susceptibility of bacteria, fungi, or other micro-
organisms, as applicable to antimicrobial drugs; 
‘‘(ii) that— 
‘‘(I) the safety and efficacy of such drugs in 
treating clinical infections due to such bacteria, 
fungi, or other microorganisms, as applicable, may 
or may not have been established in adequate 
and well-controlled clinical trials in order for the 
device to report the susceptibility of such bacteria, 
fungi, or other microorganisms, as applicable, to 
such drugs; and 
‘‘(II) the clinical significance of such suscepti-
bility information in those instances is unknown; 
‘‘(iii) that the approved labeling for drugs tested 
using such a device provides the uses for which the 
Secretary has approved such drugs; and 
‘‘(iv) any other information the Secretary deter-
mines appropriate to adequately convey the meaning 
of the data supporting the recognition or listing of 
susceptibility test interpretive criteria standards or 
susceptibility test interpretive criteria described in 
subparagraph (A). 
‘‘(C) The antimicrobial susceptibility testing device 
meets all other requirements to be cleared under section
H. R. 34—88 
510(k), classified under section 513(f)(2), or approved under 
section 515. 
‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) The term ‘antimicrobial susceptibility testing device’ 
means a device that utilizes susceptibility test interpretive 
criteria to determine and report the in vitro susceptibility of 
certain microorganisms to a drug (or drugs). 
‘‘(2) The term ‘qualified infectious disease product’ means 
a qualified infectious disease product designated under section 
505E(d). 
‘‘(3) The term ‘susceptibility test interpretive criteria’ 
means— 
‘‘(A) one or more specific numerical values which 
characterize the susceptibility of bacteria or other micro-
organisms to the drug tested; and 
‘‘(B) related categorizations of such susceptibility, 
including categorization of the drug as susceptible, inter-
mediate, resistant, or such other term as the Secretary 
determines appropriate. 
‘‘(4)(A) The term ‘antimicrobial drug’ means, subject to 
subparagraph (B), a systemic antibacterial or antifungal drug 
that— 
‘‘(i) is intended for human use in the treatment of 
a disease or condition caused by a bacterium or fungus; 
‘‘(ii) may include a qualified infectious disease product 
designated under section 505E(d); and 
‘‘(iii) is subject to section 503(b)(1). 
‘‘(B) If provided by the Secretary through regulations, such 
term may include— 
‘‘(i) drugs other than systemic antibacterial and 
antifungal drugs; and 
‘‘(ii) biological products (as such term is defined in 
section 351 of the Public Health Service Act) to the extent 
such products exhibit antimicrobial activity. 
‘‘(5) The term ‘interpretive criteria standard’ means a com-
pilation of susceptibility test interpretive criteria developed by 
a standard development organization that meets the criteria 
set forth in subsection (b)(2)(A)(i). 
‘‘(g) RULE OF CONSTRUCTION.—Nothing in this section shall 
be construed to— 
‘‘(1) alter the standards of evidence under subsection (c) 
or (d) of section 505 (including the substantial evidence 
standard under section 505(d)) or under section 351 of the 
Public Health Service Act (as applicable); or 
‘‘(2) with respect to clearing devices under section 510(k), 
classifying devices under section 513(f)(2), or approving devices 
under section 515— 
‘‘(A) apply with respect to any drug, device, or biological 
product, in any context other than an antimicrobial drug 
and an antimicrobial susceptibility testing device that uses 
susceptibility test interpretive criteria to characterize and 
report the susceptibility of certain bacteria, fungi, or other 
microorganisms, as applicable, to such drug to reflect 
patient morbidity and mortality in accordance with this 
section; or
H. R. 34—89 
‘‘(B) unless specifically stated, have any effect on 
authorities provided under other sections of this Act, 
including any regulations issued under such sections.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) REPEAL OF PRIOR RELATED AUTHORITY.—Section 1111 
of the Food and Drug Administration Amendments Act of 2007 
(42 U.S.C. 247d–5a), relating to identification of clinically 
susceptible concentrations of antimicrobials, is repealed. 
(2) ADDITION TO CATEGORIES OF MISBRANDED DRUGS.—Sec-
tion 502 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352) is amended by adding at the end the following: 
‘‘(dd) If it is an antimicrobial drug, as defined in section 511A(f), 
and its labeling fails to conform with the requirements under section 
511A(d).’’. 
(3) RECOGNITION OF INTERPRETIVE CRITERIA STANDARD AS 
DEVICE STANDARD.—Section 514(c)(1)(A) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360d(c)(1)(A)) is amended 
by inserting after ‘‘the Secretary shall, by publication in the 
Federal Register’’ the following: ‘‘(or, with respect to a suscepti-
bility test interpretive criteria standard under section 511A, 
by posting on the Interpretive Criteria Website in accordance 
with such section)’’. 
(c) REPORT TO CONGRESS.—Not later than 2 years after the 
date of enactment of this Act, the Secretary of Health and Human 
Services shall submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on Energy 
and Commerce of the House of Representatives a report on the 
progress made in implementing section 511A of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360a), as added by subsection 
(a). 
(d) REQUESTS
FOR
UPDATES
TO
INTERPRETIVE
CRITERIA 
WEBSITE.—Chapter 35 of title 44, United States Code, shall not 
apply to the collection of information from interested parties 
regarding updating the lists established under section 511A(b) of 
the Federal Food, Drug, and Cosmetic Act and posted on the 
Interpretive Criteria Website established under section 511A(c) of 
such Act. 
Subtitle F—Medical Device Innovations 
SEC. 3051. BREAKTHROUGH DEVICES. 
(a) IN GENERAL.—Chapter V of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 515B, as added by section 3034(b), the following: 
‘‘SEC. 515C. BREAKTHROUGH DEVICES. 
‘‘(a) PURPOSE.—The purpose of this section is to encourage 
the Secretary, and provide the Secretary with sufficient authority, 
to apply efficient and flexible approaches to expedite the develop-
ment of, and prioritize the Food and Drug Administration’s review 
of, devices that represent breakthrough technologies. 
‘‘(b) ESTABLISHMENT OF PROGRAM.—The Secretary shall estab-
lish a program to expedite the development of, and provide for 
the priority review for, devices, as determined by the Secretary—
H. R. 34—90 
‘‘(1) that provide for more effective treatment or diagnosis 
of life-threatening or irreversibly debilitating human disease 
or conditions; and 
‘‘(2)(A) that represent breakthrough technologies; 
‘‘(B) for which no approved or cleared alternatives exist; 
‘‘(C) that offer significant advantages over existing 
approved or cleared alternatives, including the potential, com-
pared to existing approved alternatives, to reduce or eliminate 
the need for hospitalization, 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. 
‘‘(c) REQUEST FOR DESIGNATION.—A sponsor of a device may 
request that the Secretary designate such device for expedited 
development and priority review under this section. Any such 
request for designation may be made at any time prior to the 
submission of an application under section 515(c), a notification 
under section 510(k), or a petition for classification under section 
513(f)(2). 
‘‘(d) DESIGNATION PROCESS.— 
‘‘(1) IN GENERAL.—Not later than 60 calendar days after 
the receipt of a request under subsection (c), the Secretary 
shall determine whether the device that is the subject of the 
request meets the criteria described in subsection (b). If the 
Secretary determines that the device meets the criteria, the 
Secretary shall designate the device for expedited development 
and priority review. 
‘‘(2) REVIEW.—Review of a request under subsection (c) 
shall be undertaken by a team that is composed of experienced 
staff and senior managers of the Food and Drug Administration. 
‘‘(3) WITHDRAWAL.—The Secretary may not withdraw a des-
ignation granted under this section on the basis of the criteria 
under subsection (b) no longer applying because of the subse-
quent clearance or approval of another device that— 
‘‘(A) was designated under this section; or 
‘‘(B) was given priority review under section 515(d)(5), 
as in effect prior to the date of enactment of the 21st 
Century Cures Act. 
‘‘(e) EXPEDITED DEVELOPMENT AND PRIORITY REVIEW.— 
‘‘(1) ACTIONS.—For purposes of expediting the development 
and review of devices designated under subsection (d) the Sec-
retary shall— 
‘‘(A) assign a team of staff, including a team leader 
with appropriate subject matter expertise and experience, 
for each device for which a request is submitted under 
subsection (c); 
‘‘(B) provide for oversight of the team by senior agency 
personnel to facilitate the efficient development of the 
device and the efficient review of any submission described 
in subsection (c) for the device; 
‘‘(C) adopt an efficient process for timely dispute resolu-
tion; 
‘‘(D) provide for interactive and timely communication 
with the sponsor of the device during the development 
program and review process;
H. R. 34—91 
‘‘(E) expedite the Secretary’s review of manufacturing 
and quality systems compliance, as applicable; 
‘‘(F) disclose to the sponsor, not less than 5 business 
days in advance, the topics of any consultation the Sec-
retary intends to undertake with external experts or an 
advisory committee concerning the sponsor’s device and 
provide the sponsor the opportunity to recommend such 
external experts; 
‘‘(G) provide for advisory committee input, as the Sec-
retary determines appropriate (including in response to 
the request of the sponsor) for applications submitted under 
section 515(c); and 
‘‘(H) assign staff to be available within a reasonable 
time to address questions by institutional review commit-
tees concerning the conditions and clinical testing require-
ments applicable to the investigational use of the device 
pursuant to an exemption under section 520(g). 
‘‘(2) ADDITIONAL
ACTIONS.—In addition to the actions 
described in paragraph (1), for purposes of expediting the 
development and review of devices designated under subsection 
(d), the Secretary, in collaboration with the device sponsor, 
may, as appropriate— 
‘‘(A) coordinate with the sponsor regarding early agree-
ment on a data development plan; 
‘‘(B) take steps to ensure that the design of clinical 
trials is as efficient and flexible as practicable, when sci-
entifically appropriate; 
‘‘(C) facilitate, when scientifically appropriate, expe-
dited and efficient development and review of the device 
through utilization of timely postmarket data collection 
with regard to application for approval under section 515(c); 
and 
‘‘(D) agree in writing to clinical protocols that the Sec-
retary will consider binding on the Secretary and the 
sponsor, subject to— 
‘‘(i) changes to such protocols agreed to in writing 
by the sponsor and the Secretary; or 
‘‘(ii) a decision, made by the director of the office 
responsible for reviewing the device submission, that 
a substantial scientific issue essential to determining 
the safety or effectiveness of such device exists, pro-
vided that such decision is in writing, and is made 
only after the Secretary provides to the device sponsor 
or applicant an opportunity for a meeting at which 
the director and the sponsor or applicant are present 
and at which the director documents the substantial 
scientific issue. 
‘‘(f) PRIORITY REVIEW GUIDANCE.— 
‘‘(1) CONTENT.—Not later than 1 year after the date of 
enactment of the 21st Century Cures Act, the Secretary shall 
issue guidance on the implementation of this section. Such 
guidance shall— 
‘‘(A) set forth the process by which a person may seek 
a designation under subsection (d); 
‘‘(B) provide a template for requests under subsection 
(c);
H. R. 34—92 
‘‘(C) identify the criteria the Secretary will use in evalu-
ating a request for designation under this section; and 
‘‘(D) identify the criteria and processes the Secretary 
will use to assign a team of staff, including team leaders, 
to review devices designated for expedited development 
and priority review, including any training required for 
such personnel to ensure effective and efficient review. 
‘‘(2) PROCESS.—Prior to finalizing the guidance under para-
graph (1), the Secretary shall seek public comment on a pro-
posed guidance. 
‘‘(g) RULE OF CONSTRUCTION.—Nothing in this section shall 
be construed to affect— 
‘‘(1) the criteria and standards for evaluating an application 
pursuant to section 515(c), a report and request for classification 
under section 513(f)(2), or a report under section 510(k), 
including the recognition of valid scientific evidence as 
described in section 513(a)(3)(B) and consideration and applica-
tion of the least burdensome means of evaluating device 
effectiveness or demonstrating substantial equivalence between 
devices 
with 
differing 
technological 
characteristics, 
as 
applicable; 
‘‘(2) the authority of the Secretary with respect to clinical 
holds under section 520(g)(8)(A); 
‘‘(3) the authority of the Secretary to act on an application 
pursuant to section 515(d) before completion of an establish-
ment inspection, as the Secretary determines appropriate; or 
‘‘(4) the authority of the Secretary with respect to 
postmarket surveillance under sections 519(h) and 522.’’. 
(b) DOCUMENTATION AND REVIEW OF SIGNIFICANT DECISIONS.— 
Section 517A(a)(1) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360g–1(a)(1)) is amended by inserting ‘‘a request for 
designation under section 515C,’’ after ‘‘application under section 
515,’’. 
(c) TERMINATION OF PREVIOUS PROGRAM.— 
(1) IN GENERAL.—Section 515(d) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360e(d)) is amended— 
(A) by striking paragraph (5); and 
(B) by redesignating paragraph (6) as paragraph (5). 
(2) CONFORMING AMENDMENT.—Section 737(5) of the Fed-
eral Food, Drug, and Cosmetics Act (21 U.S.C. 379i(5)) is 
amended by striking ‘‘515(d)(6)’’ and inserting ‘‘515(d)(5)’’. 
(d) REPORT.—On January 1, 2019, the Secretary of Health 
and Human Services shall issue a report to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of Representa-
tives— 
(1) on the program under section 515C of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection (a), 
in bringing safe and effective devices included in such program 
to patients as soon as possible; and 
(2) that includes recommendations, if any, to strengthen 
the program to better meet patient device needs in a manner 
as timely as possible. 
SEC. 3052. HUMANITARIAN DEVICE EXEMPTION. 
(a) IN GENERAL.—Section 520(m) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360j) is amended—
H. R. 34—93 
(1) in paragraph (1) by striking ‘‘fewer than 4,000’’ and 
inserting ‘‘not more than 8,000’’; 
(2) in paragraph (2)(A) by striking ‘‘fewer than 4,000’’ and 
inserting ‘‘not more than 8,000’’; and 
(3) in paragraph (6)(A)(ii), by striking ‘‘4,000’’ and inserting 
‘‘8,000’’. 
(b) GUIDANCE DOCUMENT ON PROBABLE BENEFIT.—Not later 
than 18 months after the date of enactment of this Act, the Sec-
retary of Health and Human Services, acting through the Commis-
sioner of Food and Drugs, shall publish a draft guidance that 
defines the criteria for establishing ‘‘probable benefit’’ as that term 
is used in section 520(m)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(m)(2)(C)). 
SEC. 3053. RECOGNITION OF STANDARDS. 
(a) IN GENERAL.—Section 514(c) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360d(c)) is amended— 
(1) in paragraph (1), by inserting after subparagraph (B) 
the following new subparagraphs: 
‘‘(C)(i) Any person may submit a request for recognition under 
subparagraph (A) of all or part of an appropriate standard estab-
lished by a nationally or internationally recognized standard 
organization. 
‘‘(ii) Not later than 60 calendar days after the Secretary receives 
such a request, the Secretary shall— 
‘‘(I) make a determination to recognize all, part, or none 
of the standard that is the subject of the request; and 
‘‘(II) issue to the person who submitted such request a 
response in writing that states the Secretary’s rationale for 
that determination, including the scientific, technical, regu-
latory, or other basis for such determination. 
‘‘(iii) The Secretary shall make a response issued under clause 
(ii)(II) publicly available, in such a manner as the Secretary deter-
mines appropriate. 
‘‘(iv) The Secretary shall take such actions as may be necessary 
to implement all or part of a standard recognized under clause 
(ii)(I), in accordance with subparagraph (A). 
‘‘(D) The Secretary shall make publicly available, in such 
manner as the Secretary determines appropriate, the rationale for 
recognition under subparagraph (A) of all, part, or none of a 
standard, including the scientific, technical, regulatory, or other 
basis for the decision regarding such recognition.’’; and 
(2) by adding at the end the following: 
‘‘(4) The Secretary shall provide to all employees of the Food 
and Drug Administration who review premarket submissions for 
devices periodic training on the concept and use of recognized 
standards for purposes of meeting a premarket submission require-
ment or other applicable requirement under this Act, including 
standards relevant to an employee’s area of device review.’’. 
(b) GUIDANCE.—The Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall review 
and update, if necessary, previously published guidance and 
standard operating procedures identifying the principles for recog-
nizing standards, and for withdrawing the recognition of standards, 
under section 514(c) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360d(c)), taking into account the experience with and 
reliance on a standard by foreign regulatory authorities and the
H. R. 34—94 
device industry, and whether recognition of a standard will promote 
harmonization among regulatory authorities in the regulation of 
devices. 
SEC. 3054. CERTAIN CLASS I AND CLASS II DEVICES. 
(a) CLASS I DEVICES.—Section 510(l) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360(l)) is amended— 
(1) by striking ‘‘A report under subsection (k)’’ and inserting 
‘‘(1) A report under subsection (k)’’; and 
(2) by adding at the end the following new paragraph: 
‘‘(2) Not later than 120 calendar days after the date of enact-
ment of the 21st Century Cures Act and at least once every 5 
years thereafter, as the Secretary determines appropriate, the Sec-
retary shall identify, through publication in the Federal Register, 
any type of class I device that the Secretary determines no longer 
requires a report under subsection (k) to provide reasonable assur-
ance of safety and effectiveness. Upon such publication— 
‘‘(A) each type of class I device so identified shall be exempt 
from the requirement for a report under subsection (k); and 
‘‘(B) the classification regulation applicable to each such 
type of device shall be deemed amended to incorporate such 
exemption.’’. 
(b) CLASS II DEVICES.—Section 510(m) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360(m)) is amended— 
(1) by striking ‘‘(m)(1)’’ and all that follows through ‘‘by 
the Secretary.’’ and inserting the following: 
‘‘(m)(1) The Secretary shall— 
‘‘(A) not later than 90 days after the date of enactment 
of the 21st Century Cures Act and at least once every 5 years 
thereafter, as the Secretary determines appropriate— 
‘‘(i) publish in the Federal Register a notice that con-
tains a list of each type of class II device that the Secretary 
determines no longer requires a report under subsection 
(k) to provide reasonable assurance of safety and effective-
ness; and 
‘‘(ii) provide for a period of not less than 60 calendar 
days for public comment beginning on the date of the 
publication of such notice; and 
‘‘(B) not later than 210 calendar days after the date of 
enactment of the 21st Century Cures Act, publish in the Federal 
Register a list representing the Secretary’s final determination 
with respect to the devices contained in the list published 
under subparagraph (A).’’; and 
(2) in paragraph (2)— 
(A) by striking ‘‘1 day after the date of publication 
of a list under this subsection,’’ and inserting ‘‘1 calendar 
day after the date of publication of the final list under 
paragraph (1)(B),’’; and 
(B) by striking ‘‘30-day period’’ and inserting ‘‘60-cal-
endar-day period’’; and 
(C) by adding at the end the following new paragraph: 
‘‘(3) Upon the publication of the final list under paragraph 
(1)(B)— 
‘‘(A) each type of class II device so listed shall be exempt 
from the requirement for a report under subsection (k); and
H. R. 34—95 
‘‘(B) the classification regulation applicable to each such 
type of device shall be deemed amended to incorporate such 
exemption.’’. 
SEC. 3055. CLASSIFICATION PANELS. 
(a) CLASSIFICATION PANELS.—Paragraph (5) of section 513(b) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) 
is amended— 
(1) by striking ‘‘(5)’’ and inserting ‘‘(5)(A)’’; and 
(2) by adding at the end the following: 
‘‘(B) When a device is specifically the subject of review by 
a classification panel, the Secretary shall— 
‘‘(i) ensure that adequate expertise is represented on the 
classification panel to assess— 
‘‘(I) the disease or condition which the device is 
intended to cure, treat, mitigate, prevent, or diagnose; and 
‘‘(II) the technology of the device; and 
‘‘(ii) provide an opportunity for the person whose device 
is specifically the subject of panel review to provide rec-
ommendations on the expertise needed among the voting mem-
bers of the panel. 
‘‘(C) For purposes of subparagraph (B)(i), the term ‘adequate 
expertise’ means that the membership of the classification panel 
includes— 
‘‘(i) two or more voting members, with a specialty or other 
expertise clinically relevant to the device under review; and 
‘‘(ii) at least one voting member who is knowledgeable 
about the technology of the device. 
‘‘(D) The Secretary shall provide an annual opportunity for 
patients, representatives of patients, and sponsors of medical device 
submissions to provide recommendations for individuals with appro-
priate expertise to fill voting member positions on classification 
panels.’’. 
(b) PANEL REVIEW PROCESS.—Section 513(b)(6) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is amended— 
(1) in subparagraph (A)(iii), by inserting before the period 
at the end ‘‘, including, subject to the discretion of the panel 
chairperson, by designating a representative who will be pro-
vided a time during the panel meeting to address the panel 
for the purpose of correcting misstatements of fact or providing 
clarifying information, and permitting the person or representa-
tive to call on experts within the person’s organization to 
address such specific issues in the time provided’’; and 
(2) by striking subparagraph (B) and inserting the following 
new subparagraph: 
‘‘(B)(i) Any meeting of a classification panel with respect to 
the review of a device shall— 
‘‘(I) provide adequate time for initial presentations by the 
person whose device is specifically the subject of such review 
and by the Secretary; and 
‘‘(II) encourage free and open participation by all interested 
persons. 
‘‘(ii) Following the initial presentations described in clause (i), 
the panel may— 
‘‘(I) pose questions to a designated representative described 
in subparagraph (A)(iii); and