2002’’ and inserting ‘‘Beginning in fiscal year 
2008’’; and 
(B) by amending the designation and 
heading of paragraph (2) to read as follows: 
‘‘(2) PREMARKET
APPLICATION, PREMARKET 
REPORT, SUPPLEMENT, AND SUBMISSION FEE, AND 
ANNUAL
FEE
FOR
PERIODIC
REPORTING
CON-
CERNING A CLASS III DEVICE.—’’. 
(2) FEE AMOUNTS.—Section 738(a)(2)(A) (21 
U.S.C. 379j(a)(2)(A)) is amended— 
(A) in clause (iii), by striking ‘‘a fee equal 
to the fee that applies’’ and inserting ‘‘a fee 
equal to 75 percent of the fee that applies’’; 
(B) in clause (iv), by striking ‘‘21.5 per-
cent’’ and inserting ‘‘15 percent’’; 
(C) in clause (v), by striking ‘‘7.2 percent’’ 
and inserting ‘‘7 percent’’; 
(D) by redesignating clauses (vi) and (vii) 
as clauses (vii) and (viii), respectively; 
(E) by inserting after clause (v) the fol-
lowing: 
‘‘(vi) For a 30-day notice, a fee equal 
to 1.6 percent of the fee that applies under 
clause (i).’’; 
(F) in clause (viii), as so redesignated—
(i) by striking ‘‘1.42 percent’’ and in-
serting ‘‘1.84 percent’’; and 
(ii) by striking ‘‘, subject to any ad-
justment under subsection (e)(2)(C)(ii)’’; 
and 
(G) by inserting after such clause (viii) the 
following: 
‘‘(ix) For a request for classification 
information, a fee equal to 1.35 percent of 
the fee that applies under clause (i). 
‘‘(x) For periodic reporting concerning 
a class III device, an annual fee equal to 
3.5 percent of the fee that applies under 
clause (i).’’. 
(3) 
PAYMENT.—Section 
738(a)(2)(C) 
(21 
U.S.C. 379j(a)(2)(C)) is amended to read as follows: 
‘‘(C) PAYMENT.—The fee required by sub-
paragraph (A) shall be due upon submission of 
the premarket application, premarket report, 
supplement, premarket notification submission, 
30-day notice, request for classification infor-
mation, or periodic reporting concerning a class 
III device. Applicants submitting portions of 
applications pursuant to section 515(c)(4) shall
pay such fees upon submission of the first por-
tion of such applications.’’. 
(4) 
REFUNDS.—Section 
738(a)(2)(D) 
(21 
U.S.C. 379j(a)(2)(D)) is amended— 
(A) in clause (iii), by striking the last two 
sentences; and 
(B) by adding after clause (iii) the fol-
lowing: 
‘‘(iv) MODULAR APPLICATIONS WITH-
DRAWN BEFORE FIRST ACTION.—The Sec-
retary shall refund 75 percent of the appli-
cation fee paid for an application sub-
mitted under section 515(c)(4) that is 
withdrawn before a second portion is sub-
mitted and before a first action on the first 
portion. 
‘‘(v) LATER
WITHDRAWN
MODULAR 
APPLICATIONS.—If an application sub-
mitted under section 515(c)(4) is with-
drawn after a second or subsequent portion 
is submitted but before any first action, 
the Secretary may return a portion of the 
fee. The amount of refund, if any, shall be 
based on the level of effort already ex-
pended on the review of the portions sub-
mitted. 
‘‘(vi) 
SOLE
DISCRETION
TO
RE-
FUND.—The Secretary shall have sole dis-
cretion to refund a fee or portion of the fee 
under clause (iii) or (v). A determination 
by the Secretary concerning a refund 
under clause (iii) or (v) shall not be review-
able.’’. 
(5) ANNUAL
ESTABLISHMENT
REGISTRATION 
FEE.—Section 738(a) (21 U.S.C. 379j(a)) is amend-
ed by adding after paragraph (2) the following: 
‘‘(3) ANNUAL ESTABLISHMENT REGISTRATION 
FEE.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), each establishment subject 
to a registration fee shall be subject to a fee for 
each initial or annual registration under section 
510 beginning with its registration for fiscal 
year 2008. 
‘‘(B) EXCEPTION.—No fee shall be re-
quired under subparagraph (A) for an estab-
lishment operated by a State or Federal govern-
mental entity or an Indian tribe (as defined in 
the Indian Self Determination and Educational
Assistance Act), unless a device manufactured 
by the establishment is to be distributed com-
mercially. 
‘‘(C) PAYMENT.—The fee required under 
subparagraph (A) shall be due once each fiscal 
year, upon the initial registration of the estab-
lishment or upon the annual registration under 
section 510.’’. 
(b) FEE AMOUNTS.—Section 738(b) (21 U.S.C. 
379j(b)) is amended to read as follows: 
‘‘(b) FEE
AMOUNTS.—Except as provided in 
subsections (c), (d), (e), and (h) the fees under sub-
section (a) shall be based on the following fee 
amounts: 
Fee Type 
Fiscal 
Year 
2008 
Fiscal 
Year 
2009 
Fiscal 
Year 
2010 
Fiscal 
Year 
2011 
Fiscal 
Year 
2012 
Premarket Appli-
cation ..............
$185,000 
$200,725 
$217,787 
$236,298 
$256,384
................
Establishment 
Registration ....
$1,706 
$1,851 
$2,008 
$2,179 
$2,364.’’. 
(c) ANNUAL FEE SETTING.— 
(1) IN GENERAL.—Section 738(c) (21 U.S.C. 
379j(c)(1)) is amended—
(A) in the subsection heading, by striking 
‘‘Annual Fee Setting’’ and inserting ‘‘ANNUAL 
FEE SETTING’’; and 
(B) in paragraph (1), by striking the last 
sentence. 
(2) ADJUSTMENT OF ANNUAL ESTABLISHMENT 
FEE.—Section 738(c) (21 U.S.C. 379j(c)), as 
amended by paragraph (1), is further amended— 
(A) by redesignating paragraphs (2) and 
(3) as paragraphs (3) and (4), respectively; 
(B) by inserting after paragraph (1) the 
following: 
‘‘(2) ADJUSTMENT.— 
‘‘(A) IN GENERAL.—When setting fees for 
fiscal year 2010, the Secretary may increase the 
fee under subsection (a)(3)(A) (applicable to es-
tablishments subject to registration) only if the 
Secretary estimates that the number of estab-
lishments submitting fees for fiscal year 2009 is 
fewer than 12,250. The percentage increase 
shall be the percentage by which the estimate of 
establishments submitting fees in fiscal year 
2009 is fewer than 12,750, but in no case may 
the percentage increase be more than 8.5 per-
cent over that specified in subsection (b) for fis-
cal year 2010. If the Secretary makes any ad-
justment to the fee under subsection (a)(3)(A) 
for fiscal year 2010, then such fee for fiscal 
years 2011 and 2012 shall be adjusted so that 
such fee for fiscal year 2011 is equal to the ad-
justed fee for fiscal year 2010 increased by 8.5 
percent, and such fee for fiscal year 2012 is 
equal to the adjusted fee for fiscal year 2011 
increased by 8.5 percent. 
‘‘(B) PUBLICATION.—For any adjustment 
made under subparagraph (A), the Secretary 
shall publish in the Federal Register the Sec-
retary’s determination to make the adjustment 
and the rationale for the determination.’’; and 
(C) in paragraph (4), as redesignated by 
this paragraph, in subparagraph (A)— 
(i) by striking ‘‘For fiscal years 2006 
and 2007, the Secretary’’ and inserting 
‘‘The Secretary’’; and 
(ii) by striking ‘‘for the first month of 
fiscal year 2008’’ and inserting ‘‘for the 
first month of the next fiscal year’’. 
(d) SMALL BUSINESSES; FEE WAIVER AND FEE RE-
DUCTION REGARDING PREMARKET APPROVAL.—
(1) IN
GENERAL.—Section 
738(d)(1) 
(21 
U.S.C. 379j(d)(1)) is amended— 
(A) by striking ‘‘, partners, and parent 
firms’’; and 
(B) by striking ‘‘clauses (i) through (vi) of 
subsection (a)(2)(A)’’ and inserting ‘‘clauses (i) 
through (v) and clauses (vii), (ix), and (x) of 
subsection (a)(2)(A)’’. 
(2) RULES
RELATING
TO
PREMARKET
AP-
PROVAL FEES.— 
(A) DEFINITION.—Section 738(d)(2)(A) 
(21 U.S.C. 379j(d)(2)(A)) is amended by strik-
ing ‘‘, partners, and parent firms’’. 
(B) EVIDENCE OF QUALIFICATION.—Sec-
tion 738(d)(2)(B) (21 U.S.C. 379j(d)(2)(B)) is 
amended— 
(i) by striking ‘‘(B) EVIDENCE
OF 
QUALIFICATION.—An applicant’’ and in-
serting the following: 
‘‘(B) EVIDENCE OF QUALIFICATION.— 
‘‘(i) IN GENERAL.—An applicant’’; 
(ii) by striking ‘‘The applicant shall 
support its claim’’ and inserting the fol-
lowing:
‘‘(ii) FIRMS
SUBMITTING
TAX
RE-
TURNS TO THE UNITED STATES INTERNAL 
REVENUE
SERVICE.—The applicant shall 
support its claim’’; 
(iii) by striking ‘‘, partners, and par-
ent firms’’ each place it appears; 
(iv) by striking the last sentence and 
inserting ‘‘If no tax forms are submitted 
for any affiliate, the applicant shall certify 
that the applicant has no affiliates.’’; and 
(v) by adding at the end the following: 
‘‘(iii) FIRMS
NOT
SUBMITTING
TAX 
RETURNS TO THE UNITED STATES INTER-
NAL REVENUE SERVICE.—In the case of an 
applicant that has not previously submitted 
a Federal income tax return, the applicant 
and each of its affiliates shall demonstrate 
that it meets the definition under subpara-
graph (A) by submission of a signed cer-
tification, in such form as the Secretary 
may direct through a notice published in 
the Federal Register, that the applicant or 
affiliate meets the criteria for a small busi-
ness and a certification, in English, from 
the national taxing authority of the coun-
try in which the applicant or, if applicable, 
affiliate is headquartered. The certification 
from such taxing authority shall bear the 
official seal of such taxing authority and 
shall provide the applicant’s or affiliate’s 
gross receipts or sales for the most recent 
year in both the local currency of such 
country and in United States dollars, the 
exchange rate used in converting such local 
currency to dollars, and the dates during 
which these receipts or sales were collected. 
The applicant shall also submit a state-
ment signed by the head of the applicant’s 
firm or by its chief financial officer that 
the applicant has submitted certifications 
for all of its affiliates, or that the applicant 
has no affiliates.’’. 
(3) REDUCED FEES.—Section 738(d)(2)(C) (21 
U.S.C. 379j(d)(2)(C)) is amended to read as follows: 
‘‘(C) REDUCED
FEES.—Where the Sec-
retary finds that the applicant involved meets 
the definition under subparagraph (A), the fees 
established under subsection (c)(1) may be paid 
at a reduced rate of—
‘‘(i) 25 percent of the fee established 
under such subsection for a premarket ap-
plication, a premarket report, a supple-
ment, or periodic reporting concerning a 
class III device; and 
‘‘(ii) 50 percent of the fee established 
under such subsection for a 30-day notice 
or a request for classification informa-
tion.’’. 
(e) SMALL BUSINESSES; FEE REDUCTION REGARD-
ING PREMARKET NOTIFICATION SUBMISSIONS.— 
(1) 
IN
GENERAL.—Section 
738(e)(1) 
(21 
U.S.C. 379j(e)(1)) is amended— 
(A) by striking ‘‘2004’’ and inserting 
‘‘2008’’; and 
(B) by striking ‘‘(a)(2)(A)(vii)’’ and insert-
ing ‘‘(a)(2)(A)(viii)’’. 
(2) RULES RELATING TO PREMARKET NOTIFI-
CATION SUBMISSIONS.— 
(A) DEFINITION.—Section 738(e)(2)(A) 
(21 U.S.C. 379j(e)(2)(A)) is amended by strik-
ing ‘‘, partners, and parent firms’’. 
(B) EVIDENCE OF QUALIFICATION.—Sec-
tion 738(e)(2)(B) (21 U.S.C. 379j(e)(2)(B)) is 
amended—
(i) by striking ‘‘(B) EVIDENCE
OF 
QUALIFICATION.—An applicant’’ and in-
serting the following: 
‘‘(B) EVIDENCE OF QUALIFICATION.— 
‘‘(i) IN GENERAL.—An applicant’’; 
(ii) by striking ‘‘The applicant shall 
support its claim’’ and inserting the fol-
lowing: 
‘‘(ii) FIRMS
SUBMITTING
TAX
RE-
TURNS TO THE UNITED STATES INTERNAL 
REVENUE
SERVICE.—The applicant shall 
support its claim’’; 
(iii) by striking ‘‘, partners, and par-
ent firms’’ each place it appears; 
(iv) by striking the last sentence and 
inserting ‘‘If no tax forms are submitted 
for any affiliate, the applicant shall certify 
that the applicant has no affiliates.’’; and 
(v) by adding at the end the following: 
‘‘(iii) FIRMS
NOT
SUBMITTING
TAX 
RETURNS TO THE UNITED STATES INTER-
NAL REVENUE SERVICE.—In the case of an 
applicant that has not previously submitted 
a Federal income tax return, the applicant 
and each of its affiliates shall demonstrate
that it meets the definition under subpara-
graph (A) by submission of a signed cer-
tification, in such form as the Secretary 
may direct through a notice published in 
the Federal Register, that the applicant or 
affiliate meets the criteria for a small busi-
ness and a certification, in English, from 
the national taxing authority of the coun-
try in which the applicant or, if applicable, 
affiliate is headquartered. The certification 
from such taxing authority shall bear the 
official seal of such taxing authority and 
shall provide the applicant’s or affiliate’s 
gross receipts or sales for the most recent 
year in both the local currency of such 
country and in United States dollars, the 
exchange rate used in converting such local 
currency to dollars, and the dates during 
which these receipts or sales were collected. 
The applicant shall also submit a state-
ment signed by the head of the applicant’s 
firm or by its chief financial officer that 
the applicant has submitted certifications 
for all of its affiliates, or that the applicant 
has no affiliates.’’.
(3) REDUCED FEES.—Section 738(e)(2)(C) (21 
U.S.C. 379j(e)(2)(C)) is amended to read as follows: 
‘‘(C) REDUCED
FEES.—For fiscal year 
2008 and each subsequent fiscal year, where 
the Secretary finds that the applicant involved 
meets the definition under subparagraph (A), 
the fee for a premarket notification submission 
may be paid at 50 percent of the fee that ap-
plies under subsection (a)(2)(A)(viii), and as es-
tablished under subsection (c)(1).’’. 
(f) EFFECT OF FAILURE TO PAY FEES.—Section 
738(f) (21 U.S.C. 379j(f)) is amended to read as follows: 
‘‘(f) EFFECT OF FAILURE TO PAY FEES.— 
‘‘(1) NO
ACCEPTANCE
OF
SUBMISSIONS.—A 
premarket application, premarket report, supple-
ment, premarket notification submission, 30-day no-
tice, request for classification information, or peri-
odic reporting concerning a class III device sub-
mitted by a person subject to fees under subsection 
(a)(2) and (a)(3) shall be considered incomplete and 
shall not be accepted by the Secretary until all fees 
owed by such person have been paid. 
‘‘(2) NO REGISTRATION.—Registration informa-
tion submitted under section 510 by an establish-
ment subject to a registration fee shall be considered
incomplete and shall not be accepted by the Sec-
retary until the registration fee under subsection 
(a)(3) owed for the establishment has been paid. 
Until the fee is paid and the registration is com-
plete, the establishment is deemed to have failed to 
register in accordance with section 510.’’. 
(g) 
CONDITIONS.—Section 
738(g) 
(21 
U.S.C. 
379j(g)) is amended— 
(1) by striking paragraph (1) and inserting the 
following: 
‘‘(1) PERFORMANCE GOALS; TERMINATION OF 
PROGRAM.—With respect to the amount that, under 
the salaries and expenses account of the Food and 
Drug Administration, is appropriated for a fiscal 
year for devices and radiological products, fees may 
not be assessed under subsection (a) for the fiscal 
year, and the Secretary is not expected to meet any 
performance goals identified for the fiscal year, if— 
‘‘(A) the amount so appropriated for the 
fiscal year, excluding the amount of fees appro-
priated for the fiscal year, is more than 1 per-
cent less than $205,720,000 multiplied by the 
adjustment factor applicable to such fiscal year; 
or
‘‘(B) fees were not assessed under sub-
section (a) for the previous fiscal year.’’; and 
(2) by amending paragraph (2) to read as fol-
lows: 
‘‘(2) AUTHORITY.—If the Secretary does not 
assess fees under subsection (a) during any portion 
of a fiscal year because of paragraph (1) and if at 
a later date in such fiscal year the Secretary may as-
sess such fees, the Secretary may assess and collect 
such fees, without any modification in the rate for 
premarket applications, supplements, premarket re-
ports, premarket notification submissions, 30-day 
notices, requests for classification information, peri-
odic reporting concerning a class III device, and es-
tablishment registrations at any time in such fiscal 
year, notwithstanding the provisions of subsection 
(a) relating to the date fees are to be paid.’’. 
(h) CREDITING AND AVAILABILITY OF FEES.— 
(1) AUTHORIZATION
OF
APPROPRIATIONS.— 
Section 738(h)(3) (21 U.S.C. 379j(h)(3)) is amend-
ed to read as follows: 
‘‘(3) AUTHORIZATIONS OF APPROPRIATIONS.— 
There are authorized to be appropriated for fees 
under this section— 
‘‘(A) $48,431,000 for fiscal year 2008;
‘‘(B) $52,547,000 for fiscal year 2009; 
‘‘(C) $57,014,000 for fiscal year 2010; 
‘‘(D) $61,860,000 for fiscal year 2011; 
and 
‘‘(E) $67,118,000 for fiscal year 2012.’’. 
(2) OFFSET.—Section 738(h)(4) (21 U.S.C. 
379j(h)(3)) is amended to read as follows: 
‘‘(4) OFFSET.—If the cumulative amount of 
fees collected during fiscal years 2008, 2009, and 
2010, added to the amount estimated to be collected 
for fiscal year 2011, which estimate shall be based 
upon the amount of fees received by the Secretary 
through June 30, 2011, exceeds the amount of fees 
specified in aggregate in paragraph (3) for these 
four fiscal years, the aggregate amount in excess 
shall be credited to the appropriation account of the 
Food and Drug Administration as provided in para-
graph (1), and shall be subtracted from the amount 
of fees that would otherwise be authorized to be col-
lected under this section pursuant to appropriation 
Acts for fiscal year 2012.’’. 
SEC. 213. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Part 3 of subchapter C of chapter VII is amended 
by inserting after section 738 the following:
tions for changes to this part as expressed under 
paragraph (2). 
‘‘(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.— 
‘‘(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 
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-
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: 
‘‘(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 
‘‘(B) each establishment subject to the require-
ments of subparagraph (A) shall thereafter— 
‘‘(i) with respect to drugs, register with the 
Secretary on or before December 31 of each 
year; and 
‘‘(ii) with respect to devices, register with 
the Secretary during the period beginning on 
October 1 and ending on December 31 of each 
year.’’. 
SEC. 223. FILING OF LISTS OF DRUGS AND DEVICES MANU-
FACTURED, PREPARED, PROPAGATED, AND 
COMPOUNDED 
BY 
REGISTRANTS; 
STATE-
MENTS; ACCOMPANYING DISCLOSURES. 
Section 510(j)(2) (21 U.S.C. 360(j)(2)) is amended, 
in the matter preceding subparagraph (A), by striking 
‘‘Each person’’ and all that follows through ‘‘the following 
information:’’ and inserting ‘‘Each person who registers 
with the Secretary under this section shall report to the 
Secretary, with regard to drugs once during the month 
of June of each year and once during the month of Decem-
ber of each year, and with regard to devices once each
year during the period beginning on October 1 and ending 
on December 31, the following information:’’. 
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 
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— 
(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 
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 
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-
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 
‘‘(bb) at least 1 of such devices is 
marketed, or is intended to be marketed, 
in 1 or more foreign countries, 1 of which 
countries certifies, accredits, or otherwise 
recognizes the person accredited under 
paragraph (2) and identified under sub-
clause (III) as a person authorized to con-
duct inspections of device establishments. 
‘‘(B)(i) Except with respect to the requirement of 
subparagraph (A)(i), a device establishment is deemed to 
have clearance to participate in the program and to use 
the accredited person identified in the notice under sub-
paragraph (A)(ii) for inspections of the establishment un-
less the Secretary, not later than 30 days after receiving 
such notice, issues a response that— 
‘‘(I) denies clearance to participate as provided 
under subparagraph (C); or 
‘‘(II) makes a request under clause (ii). 
‘‘(ii) The Secretary may request from the owner or 
operator of a device establishment in response to the no-
tice under subparagraph (A)(ii) with respect to the estab-
lishment, or from the particular accredited person identi-
fied in such notice—
‘‘(I) compliance data for the establishment in 
accordance with clause (iii)(I); or 
‘‘(II) information concerning the relationship 
between the owner or operator of the establishment 
and the accredited person identified in such notice in 
accordance with clause (iii)(II). 
The owner or operator of the establishment, or such ac-
credited person, as the case may be, shall respond to such 
a request not later than 60 days after receiving such re-
quest. 
‘‘(iii)(I) The compliance data to be submitted by the 
owner or operator of a device establishment in response 
to a request under clause (ii)(I) are data describing wheth-
er the quality controls of the establishment have been suf-
ficient for ensuring consistent compliance with current 
good manufacturing practice within the meaning of section 
501(h) and with other applicable provisions of this Act. 
Such data shall include complete reports of inspectional 
findings regarding good manufacturing practice or other 
quality control audits that, during the preceding 2-year 
period, were conducted at the establishment by persons 
other than the owner or operator of the establishment, to-
gether with all other compliance data the Secretary deems 
necessary. Data under the preceding sentence shall dem-
onstrate to the Secretary whether the establishment has
facilitated consistent compliance by promptly correcting 
any compliance problems identified in such inspections. 
‘‘(II) A request to an accredited person under clause 
(ii)(II) may not seek any information that is not required 
to be maintained by such person in records under sub-
section (f)(1). 
‘‘(iv) A device establishment is deemed to have clear-
ance to participate in the program and to use the accred-
ited person identified in the notice under subparagraph 
(A)(ii) for inspections of the establishment unless the Sec-
retary, not later than 60 days after receiving the informa-
tion requested under clause (ii), issues a response that de-
nies clearance to participate as provided under subpara-
graph (C). 
‘‘(C)(i) The Secretary may deny clearance to a device 
establishment if the Secretary has evidence that the cer-
tification under subparagraph (A)(ii)(IV) is untrue and 
the Secretary provides to the owner or operator of the es-
tablishment a statement summarizing such evidence. 
‘‘(ii) The Secretary may deny clearance to a device 
establishment if the Secretary determines that the estab-
lishment has failed to demonstrate consistent compliance 
for purposes of subparagraph (B)(iii)(I) and the Secretary 
provides to the owner or operator of the establishment a 
statement of the reasons for such determination.
‘‘(iii)(I) The Secretary may reject the selection of the 
accredited person identified in the notice under subpara-
graph (A)(ii) if the Secretary provides to the owner or op-
erator of the establishment a statement of the reasons for 
such rejection. Reasons for the rejection may include that 
the establishment or the accredited person, as the case 
may be, has failed to fully respond to the request, or that 
the Secretary has concerns regarding the relationship be-
tween the establishment and such accredited person. 
‘‘(II) If the Secretary rejects the selection of an ac-
credited person by the owner or operator of a device estab-
lishment, the owner or operator may make an additional 
selection of an accredited person by submitting to the Sec-
retary a notice that identifies the additional selection. 
Clauses (i) and (ii) of subparagraph (B), and subclause 
(I) of this clause, apply to the selection of an accredited 
person through a notice under the preceding sentence in 
the same manner and to the same extent as such provi-
sions apply to a selection of an accredited person through 
a notice under subparagraph (A)(ii). 
‘‘(iv) In the case of a device establishment that is de-
nied clearance under clause (i) or (ii) or with respect to 
which the selection of the accredited person is rejected 
under clause (iii), the Secretary shall designate a person 
to review the statement of reasons, or statement summa-
rizing such evidence, as the case may be, of the Secretary 
under such clause if, during the 30-day period beginning 
on the date on which the owner or operator of the estab-
lishment receives such statement, the owner or operator 
requests the review. The review shall commence not later 
than 30 days after the owner or operator requests the re-
view, unless the Secretary and the owner or operator oth-
erwise agree.’’; 
(5) in paragraph (7)— 
(A) in subparagraph (A), by striking ‘‘(A) 
Persons’’ and all that follows through the end 
and inserting the following: ‘‘(A) Persons ac-
credited under paragraph (2) to conduct inspec-
tions shall record in writing their inspection ob-
servations and shall present the observations to 
the device establishment’s designated represent-
ative and describe each observation. Addition-
ally, such accredited person shall prepare an in-
spection report in a form and manner des-
ignated by the Secretary to conduct inspections, 
taking into consideration the goals of inter-
national harmonization of quality systems 
standards. Any official classification of the in-
spection shall be determined by the Secretary.’’; 
and
(B) by adding at the end the following: 
‘‘(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.
(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-
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
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—
‘‘(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
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).’’.
103 
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-
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-
105 
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-
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
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
108 
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.
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—
112 
atric device development, production, and distribu-
tion that has been facilitated by the consortium. 
(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. 306. 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-
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)—
113 
(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 
(iii) in subparagraph (C), by inserting 
‘‘(including drugs and biological products) 
and medical devices’’ after ‘‘therapeutics’’. 
SEC. 307. POSTMARKET SURVEILLANCE. 
Section 522 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360l) is amended— 
(1) by amending the section heading and des-
ignation to read as follows: 
‘‘SEC. 522. POSTMARKET SURVEILLANCE.’’; 
(2) by striking subsection (a) and inserting the 
following: 
‘‘(a) POSTMARKET SURVEILLANCE.— 
‘‘(1) IN GENERAL.—
114 
‘‘(A) CONDUCT.—The Secretary may by 
order require a manufacturer to conduct 
postmarket surveillance for any device of the 
manufacturer that is a class II or class III de-
vice— 
‘‘(i) the failure of which would be rea-
sonably likely to have serious adverse 
health consequences; 
‘‘(ii) that is expected to have signifi-
cant use in pediatric populations; or 
‘‘(iii) that is intended to be— 
‘‘(I) implanted in the human 
body for more than 1 year; or 
‘‘(II) a life-sustaining or life-sup-
porting device used outside a device 
user facility. 
‘‘(B) CONDITION.—The Secretary may 
order a postmarket surveillance under subpara-
graph (A) as a condition to approval or clear-
ance of a device described in subparagraph 
(A)(ii). 
‘‘(2) RULE OF CONSTRUCTION.—The provisions 
of paragraph (1) shall have no effect on authorities 
otherwise provided under the Act or regulations 
issued under this Act.’’; and
115 
(3) in subsection (b)— 
(A) by striking ‘‘(b) SURVEILLANCE AP-
PROVAL.—Each’’ and inserting the following: 
‘‘(b) SURVEILLANCE APPROVAL.— 
‘‘(1) IN GENERAL.—Each’’; 
(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 SURVEILLANCE FOR PEDIATRIC 
DEVICES.—The Secretary may by order require a 
prospective surveillance period of more than 36 
months with respect to a device that is expected to 
have significant 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 de-
velopment, or the effects of growth, development, ac-
tivity level, or other factors on the safety or efficacy 
of the device. 
‘‘(c) DISPUTE RESOLUTION.—A manufacturer may 
request review under section 562 of any order or condition 
requiring postmarket surveillance under this section. Dur-
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)—
117 
‘‘(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.
118 
‘‘(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).
119 
‘‘(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;
120 
‘‘(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
121 
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
175 
a docket number by the Commissioner of Food 
and Drugs. An interested person may submit 
written comments concerning such pediatric 
studies to the Commissioner of Food and 
Drugs, and the written comments shall become 
part of the docket file with respect to each of 
the drugs. 
‘‘(C) ACTION
BY
COMMISSIONER.—The 
Commissioner of Food and Drugs shall take ap-
propriate action in response to the reports sub-
mitted under subparagraph (A) in accordance 
with paragraph (7). 
‘‘(7) REQUESTS FOR LABELING CHANGE.—Dur-
ing the 180-day period after the date on which a re-
port is submitted under paragraph (6)(A), the Com-
missioner of Food and Drugs shall— 
‘‘(A) review the report and such other data 
as are available concerning the safe and effec-
tive use in the pediatric population of the drug 
studied; 
‘‘(B) negotiate with the holders of ap-
proved applications for the drug studied for any 
labeling changes that the Commissioner of Food 
and Drugs determines to be appropriate and re-
quests the holders to make; and