I 
110TH CONGRESS 
1ST SESSION H. R. 1494 
To improve the process for the development of needed pediatric medical 
devices. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 13, 2007 
Mr. MARKEY (for himself and Mr. ROGERS of Michigan) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To improve the process for the development of needed 
pediatric medical devices. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Pediatric Medical De-
vice Safety and Improvement Act of 2007’’. 
SEC. 2. TRACKING PEDIATRIC DEVICE APPROVALS. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 515 the following: 
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‘‘SEC. 515A. PEDIATRIC USES OF DEVICES. 
‘‘(a) NEW DEVICES.— 
‘‘(1) IN GENERAL.—A person that submits to 
the Secretary an application under section 520(m), 
or an application (or supplement to an application) 
or a product development protocol under section 
515, shall include in the application or protocol the 
information described in paragraph (2). 
‘‘(2) REQUIRED
INFORMATION.—The applica-
tion or protocol described in paragraph (1) shall in-
clude, with respect to the device for which approval 
is sought and if readily available— 
‘‘(A) a description of any pediatric sub-
populations that suffer from the disease or con-
dition that the device is intended to treat, diag-
nose, or cure; and 
‘‘(B) the number of affected pediatric pa-
tients. 
‘‘(3) ANNUAL
REPORT.—Not later than 18 
months after the date of enactment of this section, 
and annually thereafter, the Secretary shall submit 
to the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on En-
ergy and Commerce of the House of Representatives 
a report that includes— 
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‘‘(A) the number of devices approved in the 
year preceding the year in which the report is 
submitted, for which there is a pediatric sub-
population that suffers from the disease or con-
dition that the device is intended to treat, diag-
nose, or cure; 
‘‘(B) the number of devices approved in 
the year preceding the year in which the report 
is submitted, labeled for use in pediatric pa-
tients; 
‘‘(C) the number of pediatric devices ap-
proved in the year preceding the year in which 
the report is submitted, exempted from a fee 
pursuant to section 738(a)(2)(B)(v); and 
‘‘(D) the review time for each device de-
scribed in subparagraphs (A), (B), and (C). 
‘‘(b) DETERMINATION
OF PEDIATRIC EFFECTIVE-
NESS BASED ON SIMILAR COURSE OF DISEASE OR CONDI-
TION OR SIMILAR EFFECT OF DEVICE ON ADULTS.— 
‘‘(1) IN GENERAL.—If the course of the disease 
or condition and the effects of the device are suffi-
ciently similar in adults and pediatric patients, the 
Secretary may conclude that adult data may be used 
to support a determination of a reasonable assur-
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ance of effectiveness in pediatric populations, as ap-
propriate. 
‘‘(2) EXTRAPOLATION
BETWEEN
SUBPOPULA-
TIONS.—A study may not be needed in each pedi-
atric subpopulation if data from one subpopulation 
can be extrapolated to another subpopulation. 
‘‘(c) PEDIATRIC SUBPOPULATION.—For purposes of 
this section, the term ‘pediatric subpopulation’ has the 
meaning given the term in section 520(m)(6)(E)(ii).’’. 
SEC. 3. MODIFICATION TO HUMANITARIAN DEVICE EXEMP-
TION. 
(a) IN GENERAL.—Section 520(m) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is 
amended— 
(1) in paragraph (3), by striking ‘‘No’’ and in-
serting ‘‘Except as provided in paragraph (6), no’’; 
(2) in paragraph (5)— 
(A) by inserting ‘‘, if the Secretary has 
reason to believe that the requirements of para-
graph (6) are no longer met,’’ after ‘‘public 
health’’; and 
(B) by adding at the end the following: ‘‘If 
the person granted an exemption under para-
graph (2) fails to demonstrate continued com-
pliance with the requirements of this sub-
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section, the Secretary may suspend or withdraw 
the exemption from the effectiveness require-
ments of sections 514 and 515 for a humani-
tarian device only after providing notice and an 
opportunity for an informal hearing.’’; and 
(3) by striking paragraph (6) and inserting 
after paragraph (5) the following new paragraphs: 
‘‘(6)(A) Except as provided in subparagraph 
(D), the prohibition in paragraph (3) shall not apply 
with respect to a person granted an exemption under 
paragraph (2) if each of the following conditions 
apply: 
‘‘(i)(I) The device with respect to which 
the exemption is granted is intended for the 
treatment or diagnosis of a disease or condition 
that occurs in pediatric patients or in a pedi-
atric subpopulation, and such device is labeled 
for use in pediatric patients or in a pediatric 
subpopulation in which the disease or condition 
occurs. 
‘‘(II) The device was not previously ap-
proved under this subsection for the pediatric 
patients or the pediatric subpopulation de-
scribed in subclause (I) prior to the date of en-
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actment of the Pediatric Medical Device Safety 
and Improvement Act of 2007. 
‘‘(ii) During any calendar year, the num-
ber of such devices distributed during that year 
does not exceed the annual distribution number 
specified by the Secretary when the Secretary 
grants such exemption. The annual distribution 
number shall be based on the number of indi-
viduals affected by the disease or condition that 
such device is intended to treat, diagnose, or 
cure, and of that number, the number of indi-
viduals likely to use the device, and the number 
of devices reasonably necessary to treat such in-
dividuals. In no case shall the annual distribu-
tion number exceed the number identified in 
paragraph (2)(A). 
‘‘(iii) Such person immediately notifies the 
Secretary if the number of such devices distrib-
uted during any calendar year exceeds the an-
nual distribution number referred to in clause 
(ii). 
‘‘(iv) The request for such exemption is 
submitted on or before October 1, 2013. 
‘‘(B) The Secretary may inspect the records re-
lating to the number of devices distributed during 
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any calendar year of a person granted an exemption 
under paragraph (2) for which the prohibition in 
paragraph (3) does not apply. 
‘‘(C) A person may petition the Secretary to 
modify the annual distribution number specified by 
the Secretary under subparagraph (A)(ii) with re-
spect to a device if additional information on the 
number of individuals affected by the disease or con-
dition arises, and the Secretary may modify such 
number but in no case shall the annual distribution 
number exceed the number identified in paragraph 
(2)(A). 
‘‘(D) If a person notifies the Secretary, or the 
Secretary determines through an inspection under 
subparagraph (B), that the number of devices dis-
tributed during any calendar year exceeds the an-
nual distribution number, as required under sub-
paragraph (A)(iii), and modified under subpara-
graph (C), if applicable, then the prohibition in 
paragraph (3) shall apply with respect to such per-
son for such device for any sales of such device after 
such notification. 
‘‘(E)(i) In this subsection, the term ‘pediatric 
patients’ means patients who are 21 years of age or 
younger at the time of the diagnosis or treatment. 
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‘‘(ii) In this subsection, the term ‘pediatric sub-
population’ means 1 of the following populations: 
‘‘(I) Neonates. 
‘‘(II) Infants. 
‘‘(III) Children. 
‘‘(IV) Adolescents. 
‘‘(7) The Secretary shall refer any report of an 
adverse event regarding a device for which the prohi-
bition under paragraph (3) does not apply pursuant 
to paragraph (6)(A) that the Secretary receives to 
the Office of Pediatric Therapeutics, established 
under section 6 of the Best Pharmaceuticals for 
Children Act (Public Law 107–109)). In considering 
the report, the Director of the Office of Pediatric 
Therapeutics, in consultation with experts in the 
Center for Devices and Radiological Health, shall 
provide for periodic review of the report by the Pedi-
atric Advisory Committee, including obtaining any 
recommendations of such committee regarding 
whether the Secretary should take action under this 
Act in response to the report. 
‘‘(8) In consultation with the Office of Pediatric 
Therapeutics and the Center for Devices and Radio-
logical Health, the Secretary shall provide for an an-
nual review by the Pediatric Advisory Committee of 
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all devices described in section 520(m)(6) to ensure 
that the exemption under section 520(m)(2) remains 
appropriate for the pediatric populations for which it 
is granted.’’. 
(b) REPORT.—Not later than January 1, 2012, the 
Comptroller General of the United States shall submit to 
the Committee on Health, Education, Labor, and Pen-
sions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives a report on 
the impact of allowing persons granted an exemption 
under section 520(m)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(m)(2)) with respect to a 
device to profit from such device pursuant to section 
520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as amend-
ed by subsection (a)), including— 
(1) an assessment of whether such section 
520(m)(6) (as amended by subsection (a)) has in-
creased the availability of pediatric devices for condi-
tions that occur in small numbers of children, in-
cluding any increase or decrease in the number of— 
(A) exemptions granted under such section 
520(m)(2) for pediatric devices; and 
(B) applications approved under section 
515 of such Act (21 U.S.C. 360e) for devices 
intended to treat, diagnose, or cure conditions 
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that occur in pediatric patients or for devices 
labeled for use in a pediatric population; 
(2) the conditions or diseases the pediatric de-
vices were intended to treat or diagnose and the esti-
mated size of the pediatric patient population for 
each condition or disease; 
(3) the costs of the pediatric devices, based on 
a survey of children’s hospitals; 
(4) the extent to which the costs of such devices 
are covered by health insurance; 
(5) the impact, if any, of allowing profit on ac-
cess to such devices for patients; 
(6) the profits made by manufacturers for each 
device that receives an exemption; 
(7) an estimate of the extent of the use of the 
pediatric devices by both adults and pediatric popu-
lations for a condition or disease other than the con-
dition or disease on the label of such devices; 
(8) recommendations of the Comptroller Gen-
eral of the United States regarding the effectiveness 
of such section 520(m)(6) (as amended by sub-
section (a)) and whether any modifications to such 
section 520(m)(6) (as amended by subsection (a)) 
should be made; 
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(9) existing obstacles to pediatric device devel-
opment; and 
(10) an evaluation of the demonstration grants 
described in section 5. 
(c) GUIDANCE.—Not later than 180 days after the 
date of enactment of this Act, the Commissioner of Food 
and Drugs shall issue guidance for institutional review 
committees on how to evaluate requests for approval for 
devices for which a humanitarian device exemption under 
section 520(m)(2) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360j(m)(2)) has been granted. 
SEC. 4. ENCOURAGING PEDIATRIC MEDICAL DEVICE RE-
SEARCH. 
(a) ACCESS TO FUNDING.—The Director of the Na-
tional Institutes of Health shall designate a contact point 
or office at the National Institutes of Health to help 
innovators and physicians access funding for pediatric 
medical device development. 
(b) PLAN FOR PEDIATRIC MEDICAL DEVICE RE-
SEARCH.— 
(1) IN
GENERAL.—Not later than 180 days 
after the date of enactment of this Act, the Commis-
sioner of Food and Drugs, in collaboration with the 
Director of the National Institutes of Health and the 
Director of the Agency for Healthcare Research and 
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Quality, 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 plan for expanding pedi-
atric medical device research and development. In 
developing such plan, the Commissioner of Food and 
Drugs shall consult with individuals and organiza-
tions with appropriate expertise in pediatric medical 
devices. 
(2) CONTENTS.—The plan under paragraph (1) 
shall include— 
(A) the current status of federally funded 
pediatric medical device research; 
(B) any gaps in such research, which may 
include a survey of pediatric medical providers 
regarding unmet pediatric medical device needs, 
as needed; and 
(C) a research agenda for improving pedi-
atric medical device development and Food and 
Drug Administration clearance or approval of 
pediatric medical devices, and for evaluating the 
short- and long-term safety and effectiveness of 
pediatric medical devices. 
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SEC. 5. DEMONSTRATION GRANTS FOR IMPROVING PEDI-
ATRIC DEVICE AVAILABILITY. 
(a) IN GENERAL.— 
(1) REQUEST FOR PROPOSALS.—Not later than 
90 days after the date of enactment of this Act, the 
Secretary of Health and Human Services shall issue 
a request for proposals for 1 or more grants or con-
tracts to nonprofit consortia for demonstration 
projects to promote pediatric device development. 
(2) DETERMINATION
ON
GRANTS
OR
CON-
TRACTS.—Not later than 180 days after the date the 
Secretary of Health and Human Services issues a 
request for proposals under paragraph (1), the Sec-
retary shall make a determination on the grants or 
contracts under this section. 
(b) APPLICATION.—A nonprofit consortium that de-
sires to receive a grant or contract under this section shall 
submit an application to the Secretary of Health and 
Human Services at such time, in such manner, and con-
taining such information as the Secretary may require. 
(c) USE OF FUNDS.—A nonprofit consortium that re-
ceives a grant or contract under this section shall— 
(1) encourage innovation by connecting quali-
fied individuals with pediatric device ideas with po-
tential manufacturers; 
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(2) mentor and manage pediatric device 
projects through the development process, including 
product identification, prototype design, device devel-
opment, and marketing; 
(3) connect innovators and physicians to exist-
ing Federal resources, including resources from the 
Food and Drug Administration, the National Insti-
tutes of Health, the Small Business Administration, 
the Department of Energy, the Department of Edu-
cation, the National Science Foundation, the De-
partment of Veterans Affairs, the Agency for 
Healthcare Research and Quality, and the National 
Institute of Standards and Technology; 
(4) assess the scientific and medical merit of 
proposed pediatric device projects; 
(5) assess business feasibility and provide busi-
ness advice; 
(6) provide assistance with prototype develop-
ment; and 
(7) provide assistance with postmarket needs, 
including training, logistics, and reporting. 
(d) COORDINATION.— 
(1) NATIONAL INSTITUTES OF HEALTH.—Each 
consortium that receives a grant or contract under 
this section shall— 
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(A) coordinate with the National Institutes 
of Health’s pediatric device contact point or of-
fice, designated under section 4; and 
(B) provide to the National Institutes of 
Health any identified pediatric device needs 
that the consortium lacks sufficient capacity to 
address or those needs in which the consortium 
has been unable to stimulate manufacturer in-
terest. 
(2) FOOD AND DRUG ADMINISTRATION.—Each 
consortium that receives a grant or contract under 
this section shall coordinate with the Commissioner 
of Food and Drugs and device companies to facili-
tate the application for approval or clearance of de-
vices labeled for pediatric use. 
(e) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
$6,000,000 for each of fiscal years 2008 through 2012. 
SEC. 6. AMENDMENTS TO OFFICE OF PEDIATRIC THERA-
PEUTICS AND PEDIATRIC ADVISORY COM-
MITTEE. 
(a) OFFICE OF PEDIATRIC THERAPEUTICS.—Section 
6(b) of the Best Pharmaceuticals for Children Act (21 
U.S.C. 393a(b)) is amended by inserting ‘‘, including in-
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creasing pediatric access to medical devices’’ after ‘‘pedi-
atric issues’’. 
(b) PEDIATRIC ADVISORY COMMITTEE.—Section 14 
of the Best Pharmaceuticals for Children Act (42 U.S.C. 
284m note) is amended— 
(1) in subsection (a), by inserting ‘‘(including 
drugs and biological products) and medical devices’’ 
after ‘‘therapeutics’’; and 
(2) in subsection (b)— 
(A) in paragraph (1), by inserting ‘‘(in-
cluding drugs and biological products) and med-
ical devices’’ after ‘‘therapeutics’’; and 
(B) in paragraph (2)— 
(i) in subparagraph (A), by striking 
‘‘and 505B’’ and inserting ‘‘505B, 510(k), 
515, and 520(m)’’; 
(ii) by striking subparagraph (B) and 
inserting the following: 
‘‘(B) identification of research priorities re-
lated to therapeutics (including drugs and bio-
logical products) and medical devices for pedi-
atric populations and the need for additional 
diagnostics and treatments for specific pediatric 
diseases or conditions;’’; and 
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(iii) in subparagraph (C), by inserting 
‘‘(including drugs and biological products) 
and medical devices’’ after ‘‘therapeutics’’. 
SEC. 7. STUDIES. 
(a) POSTMARKET STUDIES.—Section 522 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360l) is 
amended— 
(1) in subsection (a)— 
(A) by inserting ‘‘, or as a condition to ap-
proval of an application (or a supplement to an 
application) or a product development protocol 
under section 515 or as a condition to clearance 
of a premarket notification under section 
510(k),’’ after ‘‘The Secretary may by order’’; 
and 
(B) by inserting ‘‘, that is expected to have 
significant use in pediatric populations,’’ after 
‘‘health consequences’’; and 
(2) in subsection (b)— 
(A) by striking ‘‘(b) SURVEILLANCE AP-
PROVAL.—Each’’ and inserting the following: 
‘‘(b) SURVEILLANCE APPROVAL.— 
‘‘(1) IN GENERAL.—Each’’; 
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(B) by striking ‘‘The Secretary, in con-
sultation’’ and inserting ‘‘Except as provided in 
paragraph (2), the Secretary, in consultation’’; 
(C) by striking ‘‘Any determination’’ and 
inserting ‘‘Except as provided in paragraph (2), 
any determination’’; and 
(D) by adding at the end the following: 
‘‘(2) LONGER
STUDIES
FOR
PEDIATRIC
DE-
VICES.—The Secretary may by order require a pro-
spective surveillance period of more than 36 months 
with respect to a device that is expected to have sig-
nificant use in pediatric populations if such period of 
more than 36 months is necessary in order to assess 
the impact of the device on growth and development, 
or the effects of growth, development, activity level, 
or other factors on the safety or efficacy of the de-
vice.’’. 
(b) DATABASE.— 
(1) IN GENERAL.— 
(A) ESTABLISHMENT.—The Secretary of 
Health and Human Services, acting through the 
Commissioner of Food and Drugs, shall estab-
lish a publicly accessible database of studies of 
medical devices that includes all studies and 
surveillances, described in paragraph (2)(A), 
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that were in progress on the date of enactment 
of this Act or that began after such date. 
(B) ACCESSIBILITY.—Information included 
in the database under subparagraph (A) shall 
be in language reasonably accessible and under-
stood by individuals without specific expertise in 
the medical field. 
(2) STUDIES AND SURVEILLANCES.— 
(A) INCLUDED.—The database described 
in paragraph (1) shall include— 
(i) all postmarket surveillances or-
dered under section 522(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
360l(a)) or agreed to by the manufacturer; 
and 
(ii) all studies agreed to by the manu-
facturer of a medical device in conjunction 
with— 
(I) the premarket approval of 
such device under section 515 of the 
Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360e); 
(II) the clearance of a premarket 
notification 
report 
under 
section 
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510(k) of such Act (21 U.S.C. 
360(k)) with respect to such device; or 
(III) the submission of an appli-
cation under section 520(m) of such 
Act (21 U.S.C. 360j(m)) with respect 
to such device. 
(B) EXCLUDED.—The database described 
in paragraph (1) shall not include any studies 
with respect to a medical device that were com-
pleted prior to the initial approval of such de-
vice. 
(3) CONTENTS
OF
STUDY
AND
SURVEIL-
LANCE.—For each study or surveillance included in 
the database described in paragraph (1), the data-
base shall include— 
(A) information on the status of the study 
or surveillance; 
(B) basic information about the study or 
surveillance, including the purpose, the primary 
and secondary outcomes, and the population 
targeted; 
(C) the expected completion date of the 
study or surveillance; 
(D) public health notifications, including 
safety alerts; and 
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(E) any other information the Secretary of 
Health and Human Services determines appro-
priate to protect the public health. 
(4) ONCE
COMPLETED
OR
TERMINATED.—In 
addition to the information described in paragraph 
(3), once a study or surveillance has been completed 
or if a study or surveillance is terminated, the data-
base shall also include— 
(A) the actual date of completion or termi-
nation; 
(B) if the study or surveillance was termi-
nated, the reason for termination; 
(C) if the study or surveillance was sub-
mitted but not accepted by the Food and Drug 
Administration because the study or surveil-
lance did not meet the requirements for such 
study or surveillance, an explanation of the rea-
sons and any follow-up action required; 
(D) 
information 
about 
any 
labeling 
changes made to the device as a result of the 
study or surveillance findings; 
(E) information about any other decisions 
or actions of the Food and Drug Administra-
tion that result from the study or surveillance 
findings; 
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(F) lay and technical summaries of the 
study or surveillance results and key findings, 
or an explanation as to why the results and key 
findings do not warrant public availability; 
(G) a link to any peer reviewed articles on 
the study or surveillance; and 
(H) any other information the Secretary of 
Health and Human Services determines appro-
priate to protect the public health. 
(5) PUBLIC ACCESS.—The database described 
in paragraph (1) shall be— 
(A) accessible to the general public; and 
(B) easily searchable by multiple criteria, 
including whether the study or surveillance in-
volves pediatric populations. 
Æ 
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