‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning 
negotiations with the regulated industry on the reau-
thorization of this part, the Secretary shall— 
‘‘(A) publish a notice in the Federal Reg-
ister requesting public input on the reauthoriza-
tion; 
‘‘(B) hold a public meeting at which the 
public may present its views on the reauthoriza-
tion, including specific suggestions for changes 
to the goals referred to in subsection (a)(1); 
‘‘(C) provide a period of 30 days after the 
public meeting to obtain written comments from 
the public suggesting changes to this part; and 
‘‘(D) publish the comments on the Food 
and Drug Administration’s Internet Web site. 
‘‘(3) PERIODIC CONSULTATION.—Not less fre-
quently than once every month during negotiations 
with the regulated industry, the Secretary shall hold 
discussions with representatives of patient and con-
sumer advocacy groups to continue discussions of 
their views on the reauthorization and their sugges-
tions for changes to this part as expressed under 
paragraph (2). 
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‘‘(4) 
PUBLIC
REVIEW
OF
RECOMMENDA-
TIONS.—After negotiations with the regulated indus-
try, the Secretary shall— 
‘‘(A) present the recommendations devel-
oped under paragraph (1) to the Congressional 
committees specified in such paragraph; 
‘‘(B) publish such recommendations in the 
Federal Register; 
‘‘(C) provide for a period of 30 days for 
the public to provide written comments on such 
recommendations; 
‘‘(D) hold a meeting at which the public 
may present its views on such recommenda-
tions; and 
‘‘(E) after consideration of such public 
views and comments, revise such recommenda-
tions as necessary. 
‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.— 
Not later than January 15, 2012, the Secretary 
shall transmit to Congress the revised recommenda-
tions under paragraph (4), a summary of the views 
and comments received under such paragraph, and 
any changes made to the recommendations in re-
sponse to such views and comments. 
‘‘(6) MINUTES OF NEGOTIATION MEETINGS.— 
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‘‘(A) PUBLIC AVAILABILITY.—Before pre-
senting the recommendations developed under 
paragraphs (1) through (5) to the Congress, the 
Secretary shall make publicly available, on the 
public Web site of the Food and Drug Adminis-
tration, minutes of all negotiation meetings con-
ducted under this subsection between the Food 
and Drug Administration and the regulated in-
dustry. 
‘‘(B) CONTENT.—The minutes described 
under subparagraph (A) shall summarize any 
substantive proposal made by any party to the 
negotiations as well as significant controversies 
or differences of opinion during the negotiations 
and their resolution.’’. 
SEC. 214. SAVINGS CLAUSE. 
Notwithstanding section 107 of the Medical Device 
User Fee and Modernization Act of 2002 (Public Law 
107–250), and notwithstanding the amendments made by 
this subtitle, part 3 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i 
et seq.), as in effect on the day before the date of the 
enactment of this subtitle, shall continue to be in effect 
with respect to premarket applications, premarket reports, 
premarket notification submissions, and supplements (as 
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defined in such part as of such day) that on or after Octo-
ber 1, 2002, but before October 1, 2007, were accepted 
by the Food and Drug Administration for filing with re-
spect to assessing and collecting any fee required by such 
part for a fiscal year prior to fiscal year 2008. 
SEC. 215. ADDITIONAL AUTHORIZATION OF APPROPRIA-
TIONS FOR POSTMARKET SAFETY INFORMA-
TION. 
For the purpose of collecting, developing, reviewing, 
and evaluating postmarket safety information on medical 
devices, there are authorized to be appropriated to the 
Food and Drug Administration, in addition to the 
amounts authorized by other provisions of law for such 
purpose— 
(1) $7,100,000 for fiscal year 2008; 
(2) $7,455,000 for fiscal year 2009; 
(3) $7,827,750 for fiscal year 2010; 
(4) $8,219,138 for fiscal year 2011; and 
(5) $8,630,094 for fiscal year 2012. 
SEC. 216. EFFECTIVE DATE. 
The amendments made by this subtitle shall take ef-
fect on October 1, 2007, or the date of the enactment of 
this Act, whichever is later, except that fees under part 
3 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act shall be assessed for all pre-
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market applications, premarket reports, supplements, 30- 
day notices, and premarket notification submissions re-
ceived on or after October 1, 2007, regardless of the date 
of the enactment of this Act. 
SEC. 217. SUNSET CLAUSE. 
The amendments made by this subtitle cease to be 
effective October 1, 2012, except that section 738A of the 
Federal Food, Drug, and Cosmetic Act (regarding annual 
performance and financial reports) ceases to be effective 
January 31, 2013. 
Subtitle B—Amendments Regard-
ing Regulation of Medical De-
vices 
SEC. 221. EXTENSION OF AUTHORITY FOR THIRD PARTY 
REVIEW OF PREMARKET NOTIFICATION. 
Section 523(c) (21 U.S.C. 360m(c)) is amended by 
striking ‘‘2007’’ and inserting ‘‘2012’’. 
SEC. 222. REGISTRATION. 
(a) ANNUAL REGISTRATION
OF PRODUCERS
OF 
DRUGS
AND
DEVICES.—Section 510(b) (21 U.S.C. 
360(b)) is amended— 
(1) by striking ‘‘(b) On or before’’ and inserting 
‘‘(b)(1) On or before’’; 
(2) by striking ‘‘or a device or devices’’; and 
(3) by adding at the end the following: 
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‘‘(2) During the period beginning on October 1 and 
ending on December 31 of each year, every person who 
owns or operates any establishment in any State engaged 
in 
the 
manufacture, 
preparation, 
propagation, 
compounding, or processing of a device or devices shall 
register with the Secretary his name, places of business, 
and all such establishments.’’. 
(b) 
REGISTRATION
OF
FOREIGN
ESTABLISH-
MENTS.—Section 510(i)(1) (21 U.S.C. 360(i)(1)) is 
amended by striking ‘‘On or before December 31’’ and all 
that follows and inserting the following: ‘‘Any establish-
ment within any foreign country engaged in the manufac-
ture, preparation, propagation, compounding, or proc-
essing of a drug or device that is imported or offered for 
import into the United States shall, through electronic 
means in accordance with the criteria of the Secretary— 
‘‘(A) upon first engaging in any such activity, 
immediately register with the Secretary the name 
and place of business of the establishment, the name 
of the United States agent for the establishment, the 
name of each importer of such drug or device in the 
United States that is known to the establishment, 
and the name of each person who imports or offers 
for import such drug or device to the United States 
for purposes of importation; and 
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SEC. 224. ELECTRONIC REGISTRATION AND LISTING. 
Section 510(p) (21 U.S.C. 360(p)) is amended to 
read as follows: 
‘‘(p) Registrations and listings under this section (in-
cluding the submission of updated information) shall be 
submitted to the Secretary by electronic means unless the 
Secretary grants a request for waiver of such requirement 
because use of electronic means is not reasonable for the 
person requesting such waiver.’’. 
SEC. 225. REPORT BY GOVERNMENT ACCOUNTABILITY OF-
FICE. 
(a) IN GENERAL.—The Comptroller General of the 
United States shall conduct a study on the appropriate 
use of the process under section 510(k) of the Federal 
Food, Drug, and Cosmetic Act as part of the device classi-
fication process to determine whether a new device is as 
safe and effective as a classified device. 
(b) CONSIDERATION.—In determining the effective-
ness of the premarket notification and classification au-
thority under section 510(k) and subsections (f) and (i) 
of section 513 of the Federal Food, Drug, and Cosmetic 
Act, the study under subsection (a) shall consider the Sec-
retary of Health and Human Services’s evaluation of the 
respective intended uses and technologies of such devices, 
including the effectiveness of such Secretary’s comparative 
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assessment of technological characteristics such as device 
materials, principles of operations, and power sources. 
(c) REPORT.—Not later than 1 year after the date 
of the enactment of this Act, the Comptroller General shall 
complete the study under subsection (a) and submit to the 
Congress a report on the results of such study. 
SEC. 226. UNIQUE DEVICE IDENTIFICATION SYSTEM. 
(a) IN GENERAL.—Section 519 (21 U.S.C. 360i) is 
amended— 
(1) by redesignating subsection (f) as sub-
section (g); and 
(2) by inserting after subsection (e) the fol-
lowing: 
‘‘Unique Device Identification System 
‘‘(f) The Secretary shall promulgate regulations es-
tablishing a unique device identification system for med-
ical devices requiring the label of devices to bear a unique 
identifier, unless the Secretary requires an alternative 
placement or provides an exception for a particular device 
or type of device. The unique identifier shall adequately 
identify the device through distribution and use, and may 
include information on the lot or serial number.’’. 
(b) CONFORMING AMENDMENT.—Section 303 (21 
U.S.C. 333) is amended— 
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(1) by redesignating the subsection that follows 
subsection (e) as subsection (f); and 
(2) in paragraph (1)(B)(ii) of subsection (f), as 
so redesignated, by striking ‘‘519(f)’’ and inserting 
‘‘519(g)’’. 
SEC. 227. FREQUENCY OF REPORTING FOR CERTAIN DE-
VICES. 
Subparagraph (B) of section 519(a)(1) (21 U.S.C. 
360i(a)(1)) is amended by striking ‘‘were to recur;’’ and 
inserting the following: ‘‘were to recur, which report under 
this subparagraph— 
‘‘(i) shall be submitted in accordance 
with part 803 of title 21, Code of Federal 
Regulations (or successor regulations), un-
less the Secretary grants an exemption or 
variance from, or an alternative to, a re-
quirement under such regulations pursuant 
to section 803.19 of such part, if the de-
vice involved is— 
‘‘(I) a class III device; 
‘‘(II) a class II device that is per-
manently implantable, is life sup-
porting, or is life sustaining; or 
‘‘(III) a type of device which the 
Secretary has, by notice published in 
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the Federal Register or letter to the 
person who is the manufacturer or 
importer of the device, indicated 
should be subject to such part 803 in 
order to protect the public health; 
‘‘(ii) shall, if the device is not subject 
to clause (i), be submitted in accordance 
with criteria established by the Secretary 
for reports made pursuant to this clause, 
which criteria shall require the reports to 
be in summary form and made on a quar-
terly basis; or 
‘‘(iii) shall, if the device is imported 
into the United States and for which part 
803 of title 21, Code of Federal Regula-
tions (or successor regulations) requires an 
importer to submit a report to the manu-
facturer, be submitted by the importer to 
the manufacturer in accordance with part 
803 of title 21, Code of Federal Regula-
tions (or successor regulations)’’. 
SEC. 228. INSPECTIONS BY ACCREDITED PERSONS. 
Section 704(g) (21 U.S.C. 374(g)) is amended— 
(1) in paragraph (1), by striking ‘‘Not later 
than one year after the date of the enactment of this 
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subsection, the Secretary’’ and inserting ‘‘The Sec-
retary’’; 
(2) in paragraph (2), by— 
(A) striking ‘‘Not later than 180 days 
after the date of enactment of this subsection, 
the Secretary’’ and inserting ‘‘The Secretary’’; 
and 
(B) striking the fifth sentence; 
(3) in paragraph (3), by adding at the end the 
following: 
‘‘(F) Such person shall notify the Secretary of 
any withdrawal, suspension, restriction, or expiration 
of certificate of conformance with the quality sys-
tems standard referred to in paragraph (7) for any 
device establishment that such person inspects under 
this subsection not later than 30 days after such 
withdrawal, suspension, restriction, or expiration. 
‘‘(G) Such person may conduct audits to estab-
lish conformance with the quality systems standard 
referred to in paragraph (7).’’; 
(4) by amending paragraph (6) to read as fol-
lows: 
‘‘(6)(A) Subject to subparagraphs (B) and (C), a de-
vice establishment is eligible for inspection by persons ac-
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credited under paragraph (2) if the following conditions 
are met: 
‘‘(i) The Secretary classified the results of the 
most recent inspection of the establishment as ‘no 
action indicated’ or ‘voluntary action indicated’. 
‘‘(ii) With respect to inspections of the estab-
lishment to be conducted by an accredited person, 
the owner or operator of the establishment submits 
to the Secretary a notice that— 
‘‘(I) provides the date of the last inspection 
of the establishment by the Secretary and the 
classification of that inspection; 
‘‘(II) states the intention of the owner or 
operator to use an accredited person to conduct 
inspections of the establishment; 
‘‘(III) identifies the particular accredited 
person the owner or operator intends to select 
to conduct such inspections; and 
‘‘(IV) includes a certification that, with re-
spect to the devices that are manufactured, pre-
pared, propagated, compounded, or processed in 
the establishment— 
‘‘(aa) at least 1 of such devices is 
marketed in the United States; and 
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‘‘(F) For the 
purpose 
of 
setting 
risk-based 
inspectional priorities, the Secretary shall accept voluntary 
submissions of reports of audits assessing conformance 
with appropriate quality systems standards set by the 
International Organization for Standardization (ISO) and 
identified by the Secretary in public notice. If the owner 
or operator of an establishment elects to submit audit re-
ports under this subparagraph, the owner or operator shall 
submit all such audit reports with respect to the establish-
ment during the preceding 2-year periods.’’; and 
(6) in paragraph (10)(C)(iii), by striking 
‘‘based’’ and inserting ‘‘base’’. 
SEC. 229. STUDY OF NOSOCOMIAL INFECTIONS RELATING 
TO MEDICAL DEVICES. 
(a) IN GENERAL.—The Comptroller General of the 
United States shall conduct a study on— 
(1) the number of nosocomial infections attrib-
utable to new and reused medical devices; and 
(2) the causes of such nosocomial infections, in-
cluding the following: 
(A) Reprocessed single-use devices. 
(B) Handling of sterilized medical devices. 
(C) In-hospital sterilization of medical de-
vices. 
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(D) Health care professionals’ practices for 
patient examination and treatment. 
(E) Hospital-based policies and procedures 
for infection control and prevention. 
(F) Hospital-based practices for handling 
of medical waste. 
(G) Other causes. 
(b) REPORT.—Not later than 1 year after the date 
of the enactment of this Act, the Comptroller General shall 
complete the study under subsection (a) and submit to the 
Congress a report on the results of such study. 
(c) 
DEFINITION.—In 
this 
section, 
the 
term 
‘‘nosocomial infection’’ means an infection that is acquired 
while an individual is a patient at a hospital and was nei-
ther present nor incubating in the patient prior to receiv-
ing services in the hospital. 
SEC. 230. REPORT BY THE FOOD AND DRUG ADMINISTRA-
TION REGARDING LABELING INFORMATION 
ON THE RELATIONSHIP BETWEEN THE USE 
OF INDOOR TANNING DEVICES AND DEVEL-
OPMENT OF SKIN CANCER OR OTHER SKIN 
DAMAGE. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
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retary’’), acting through the Commissioner of Food and 
Drugs, shall determine— 
(1) whether the labeling requirements for in-
door tanning devices, including the positioning re-
quirements, provide sufficient information to con-
sumers regarding the risks that the use of such de-
vices pose for the development of irreversible damage 
to the eyes and skin, including skin cancer; and 
(2)(A) whether modifying the warning label re-
quired on tanning beds to read, ‘‘Ultraviolet radi-
ation can cause skin cancer’’, or any other additional 
warning, would communicate the risks of indoor tan-
ning more effectively; or 
(B) whether there is no warning that would be 
capable of adequately communicating such risks. 
(b) CONSUMER TESTING.—In making the determina-
tions under subsection (a), the Secretary shall conduct ap-
propriate consumer testing to determine consumer under-
standing of label warnings. 
(c) REPORT.—Not later than 1 year after the date 
of the enactment of this Act, the Secretary shall submit 
to the Congress a report that provides the determinations 
under subsection (a). In addition, the Secretary shall in-
clude in the report the measures being implemented by 
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the Secretary to significantly reduce the risks associated 
with indoor tanning devices. 
TITLE III—PEDIATRIC MEDICAL 
DEVICE 
SAFETY 
AND 
IM-
PROVEMENT ACT OF 2007 
SEC. 301. SHORT TITLE. 
This title may be cited as the ‘‘Pediatric Medical De-
vice Safety and Improvement Act of 2007’’. 
SEC. 302. 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: 
‘‘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— 
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‘‘(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 the enactment of this sec-
tion, and annually thereafter, the Secretary shall 
submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of 
Representatives a report that includes— 
‘‘(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 
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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-
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).’’. 
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100 
SEC. 303. MODIFICATION TO HUMANITARIAN DEVICE EX-
EMPTION. 
(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-
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 
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101 
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 ex-
emption is granted is intended for the treatment or 
diagnosis of a disease or condition that occurs in pe-
diatric patients or in a pediatric 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 approved 
under this subsection for the pediatric patients or 
the pediatric subpopulation described in subclause 
(I) prior to the date of the enactment of the Pedi-
atric Medical Device Safety and Improvement Act of 
2007. 
‘‘(ii) During any calendar year, the number of 
such devices distributed during that year does not 
exceed the annual distribution number specified by 
the Secretary when the Secretary grants such ex-
emption. The annual distribution number shall be 
based on the number of individuals affected by the 
disease or condition that such device is intended to 
treat, diagnose, or cure, and of that number, the 
number of individuals likely to use the device, and 
the number of devices reasonably necessary to treat 
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102 
such individuals. In no case shall the annual dis-
tribution number exceed the number identified in 
paragraph (2)(A). 
‘‘(iii) Such person immediately notifies the Sec-
retary if the number of such devices distributed dur-
ing any calendar year exceeds the annual distribu-
tion number referred to in clause (ii). 
‘‘(iv) The request for such exemption is sub-
mitted on or before October 1, 2012. 
‘‘(B) The Secretary may inspect the records relating 
to the number of devices distributed during 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 respect to a device if ad-
ditional information on the number of individuals affected 
by the disease or condition arises, and the Secretary may 
modify such number but in no case shall the annual dis-
tribution number exceed the number identified in para-
graph (2)(A). 
‘‘(D) If a person notifies the Secretary, or the Sec-
retary determines through an inspection under subpara-
graph (B), that the number of devices distributed during 
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any calendar year exceeds the annual distribution number, 
as required under subparagraph (A)(iii), and modified 
under subparagraph (C), if applicable, then the prohibi-
tion 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 pa-
tients’ means patients who are 21 years of age or younger 
at the time of the diagnosis or treatment. 
‘‘(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 ad-
verse event regarding a device for which the prohibition 
under paragraph (3) does not apply pursuant to para-
graph (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 pro-
vide for periodic review of the report by the Pediatric Ad-
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104 
visory Committee, including obtaining any recommenda-
tions of such committee regarding whether the Secretary 
should take action under this Act in response to the re-
port. 
‘‘(8) The Secretary, acting through the Office of Pe-
diatric Therapeutics and the Center for Devices and Radi-
ological Health, shall provide for an annual review by the 
Pediatric Advisory Committee of all devices described in 
paragraph (6) to ensure that the exemption under para-
graph (2) remains appropriate for the pediatric popu-
lations 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-
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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 
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 purchasing pediatric devices, 
based on a representative sampling of children’s hos-
pitals; 
(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-
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106 
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; 
(9) existing obstacles to pediatric device devel-
opment; and 
(10) an evaluation of the demonstration grants 
described in section 305, which shall include an eval-
uation of the number of pediatric medical devices— 
(A) that have been or are being studied in 
children; and 
(B) that have been submitted to the Food 
and Drug Administration for approval, clear-
ance, or review under such section 520(m) (as 
amended by this Act) and any regulatory ac-
tions taken. 
(c) GUIDANCE.—Not later than 180 days after the 
date of the enactment of this Act, the Commissioner of 
Food and Drugs shall issue guidance for institutional re-
view committees on how to evaluate requests for approval 
for devices for which a humanitarian device exemption 
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107 
under section 520(m)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(m)(2)) has been granted. 
SEC. 304. ENCOURAGING PEDIATRIC MEDICAL DEVICE RE-
SEARCH. 
(a) CONTACT POINT FOR AVAILABLE FUNDING.— 
Section 402(b) of the Public Health Service Act (42 
U.S.C. 282(b)) is amended— 
(1) in paragraph (21), by striking ‘‘and’’ after 
the semicolon at the end; 
(2) in paragraph (22), by striking the period at 
the end and inserting ‘‘; and’’; and 
(3) by inserting after paragraph (22) the fol-
lowing: 
‘‘(23) shall designate a contact point or office 
to help innovators and physicians identify sources of 
funding available for pediatric medical device devel-
opment.’’. 
(b) PLAN FOR PEDIATRIC MEDICAL DEVICE RE-
SEARCH.— 
(1) IN
GENERAL.—Not later than 180 days 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, the 
Director of the National Institutes of Health, and 
the Director of the Agency for Healthcare Research 
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and Quality, shall submit to the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate and the Committee on Energy and Commerce of 
the House of Representatives a plan for expanding 
pediatric medical device research and development. 
In developing such plan, the Secretary of Health and 
Human Services shall consult with individuals and 
organizations 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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109 
SEC. 305. DEMONSTRATION GRANTS FOR IMPROVING PEDI-
ATRIC DEVICE AVAILABILITY. 
(a) IN GENERAL.— 
(1) REQUEST FOR PROPOSALS.—Not later than 
90 days after the date of the enactment of this Act, 
the Secretary of Health and Human Services shall 
issue a request for proposals for 1 or more grants 
or contracts 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 facilitate 
the development, production, and distribution of pediatric 
medical devices by— 
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110 
(1) encouraging innovation and connecting 
qualified individuals with pediatric device ideas with 
potential manufacturers; 
(2) mentoring and managing pediatric device 
projects through the development process, including 
product identification, prototype design, device devel-
opment, and marketing; 
(3) connecting innovators and physicians to ex-
isting Federal and non-Federal resources, including 
resources from the Food and Drug Administration, 
the National Institutes of Health, the Small Busi-
ness Administration, the Department of Energy, the 
Department of Education, the National Science 
Foundation, the Department of Veterans Affairs, 
the Agency for Healthcare Research and Quality, 
and the National Institute of Standards and Tech-
nology; 
(4) assessing the scientific and medical merit of 
proposed pediatric device projects; and 
(5) providing assistance and advice as needed 
on business development, personnel training, proto-
type development, postmarket needs, and other ac-
tivities consistent with the purposes of this section. 
(d) COORDINATION.— 
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111 
(1) NATIONAL INSTITUTES OF HEALTH.—Each 
consortium that receives a grant or contract under 
this section shall— 
(A) coordinate with the National Institutes 
of Health’s pediatric device contact point or of-
fice, designated under section 402(b)(23) of the 
Public Health Service Act, as added by section 
304(a) of this Act; 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. 
(3) EFFECTIVENESS
AND
OUTCOMES.—Each 
consortium that receives a grant or contract under 
this section shall annually report to the Secretary of 
Health and Human Services on the status of pedi-
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116 
ing the pendency of such review, the device subject to such 
a postmarket surveillance order or condition shall not, be-
cause of noncompliance with such order or condition, be 
deemed in violation of section 301(q)(1)(C), adulterated 
under section 501(f)(1), misbranded under section 
502(t)(3), or in violation of, as applicable, section 510(k) 
or section 515, unless deemed necessary to protect the 
public health.’’. 
TITLE IV—PEDIATRIC 
RESEARCH EQUITY ACT OF 2007 
SEC. 401. SHORT TITLE. 
This title may be cited as the ‘‘Pediatric Research 
Equity Act of 2007’’. 
SEC. 402. REAUTHORIZATION OF PEDIATRIC RESEARCH EQ-
UITY ACT. 
(a) IN GENERAL.—Section 505B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355c) is amend-
ed to read as follows: 
‘‘SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS 
AND BIOLOGICAL PRODUCTS. 
‘‘(a) NEW DRUGS AND BIOLOGICAL PRODUCTS.— 
‘‘(1) IN GENERAL.—A person that submits, on 
or after the date of the enactment of the Pediatric 
Research Equity Act of 2007, an application (or 
supplement to an application)— 
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‘‘(A) under section 505 for a new active in-
gredient, new indication, new dosage form, new 
dosing regimen, or new route of administration, 
or 
‘‘(B) under section 351 of the Public 
Health Service Act (42 U.S.C. 262) for a new 
active ingredient, new indication, new dosage 
form, new dosing regimen, or new route of ad-
ministration, 
shall submit with the application the assessments de-
scribed in paragraph (2). 
‘‘(2) ASSESSMENTS.— 
‘‘(A) IN GENERAL.—The assessments re-
ferred to in paragraph (1) shall contain data, 
gathered using appropriate formulations for 
each age group for which the assessment is re-
quired, that are adequate— 
‘‘(i) to assess the safety and effective-
ness of the drug or the biological product 
for the claimed indications in all relevant 
pediatric subpopulations; and 
‘‘(ii) to support dosing and adminis-
tration for each pediatric subpopulation for 
which the drug or the biological product is 
safe and effective. 
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‘‘(B) SIMILAR
COURSE
OF
DISEASE
OR 
SIMILAR
EFFECT
OF
DRUG
OR
BIOLOGICAL 
PRODUCT.— 
‘‘(i) IN GENERAL.—If the course of 
the disease and the effects of the drug are 
sufficiently similar in adults and pediatric 
patients, the Secretary may conclude that 
pediatric effectiveness can be extrapolated 
from adequate and well-controlled studies 
in adults, usually supplemented with other 
information obtained in pediatric patients, 
such as pharmacokinetic studies. 
‘‘(ii) EXTRAPOLATION BETWEEN AGE 
GROUPS.—A study may not be needed in 
each pediatric age group if data from one 
age group can be extrapolated to another 
age group. 
‘‘(iii) INFORMATION
ON
EXTRAPO-
LATION.—A brief documentation of the sci-
entific data supporting the conclusion 
under clauses (i) and (ii) shall be included 
in any pertinent reviews for the application 
under section 505 of this Act or section 
351 of the Public Health Service Act (42 
U.S.C. 262). 
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‘‘(3) DEFERRAL.— 
‘‘(A) IN
GENERAL.—On the initiative of 
the Secretary or at the request of the applicant, 
the Secretary may defer submission of some or 
all assessments required under paragraph (1) 
until a specified date after approval of the drug 
or issuance of the license for a biological prod-
uct if— 
‘‘(i) the Secretary finds that— 
‘‘(I) the drug or biological prod-
uct is ready for approval for use in 
adults before pediatric studies are 
complete; 
‘‘(II) pediatric studies should be 
delayed until additional safety or ef-
fectiveness data have been collected; 
or 
‘‘(III) there is another appro-
priate reason for deferral; and 
‘‘(ii) the applicant submits to the Sec-
retary— 
‘‘(I) certification of the grounds 
for deferring the assessments; 
‘‘(II) a description of the planned 
or ongoing studies; 
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‘‘(III) evidence that the studies 
are being conducted or will be con-
ducted with due diligence and at the 
earliest possible time; and 
‘‘(IV) a timeline for the comple-
tion of such studies. 
‘‘(B) ANNUAL REVIEW.— 
‘‘(i) IN
GENERAL.—On an annual 
basis following the approval of a deferral 
under subparagraph (A), the applicant 
shall submit to the Secretary the following 
information: 
‘‘(I) Information detailing the 
progress made in conducting pediatric 
studies. 
‘‘(II) If no progress has been 
made in conducting such studies, evi-
dence and documentation that such 
studies will be conducted with due 
diligence and at the earliest possible 
time. 
‘‘(ii) PUBLIC AVAILABILITY.—The in-
formation submitted through the annual 
review under clause (i) shall promptly be 
made available to the public in an easily 
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accessible manner, including through the 
Web site of the Food and Drug Adminis-
tration. 
‘‘(4) WAIVERS.— 
‘‘(A) FULL WAIVER.—On the initiative of 
the Secretary or at the request of an applicant, 
the Secretary shall grant a full waiver, as ap-
propriate, of the requirement to submit assess-
ments for a drug or biological product under 
this subsection if the applicant certifies and the 
Secretary finds that— 
‘‘(i) necessary studies are impossible 
or highly impracticable (because, for exam-
ple, the number of patients is so small or 
the patients are geographically dispersed); 
‘‘(ii) there is evidence strongly sug-
gesting that the drug or biological product 
would be ineffective or unsafe in all pedi-
atric age groups; or 
‘‘(iii) the drug or biological product— 
‘‘(I) does not represent a mean-
ingful therapeutic benefit over existing 
therapies for pediatric patients; and 
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