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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— 
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‘‘(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— 
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(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 
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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.’’. 
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(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 
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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 
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‘‘(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; 
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‘‘(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: 
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‘‘SEC. 738A. REAUTHORIZATION; REPORTING REQUIRE-
MENTS. 
‘‘(a) REPORTS.— 
‘‘(1) PERFORMANCE REPORT.—For fiscal years 
2008 through 2012, not later than 120 days after 
the end of each fiscal year during which fees are col-
lected under this part, the Secretary shall prepare 
and 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 concerning the progress of 
the Food and Drug Administration in achieving the 
goals identified in the letters described in section 
201(c) of the Food and Drug Administration 
Amendments Act of 2007 during such fiscal year 
and the future plans of the Food and Drug Adminis-
tration for meeting the goals. The report for a fiscal 
year shall include information on all previous cohorts 
for which the Secretary has not given a complete re-
sponse on all device premarket applications and re-
ports, supplements, and premarket notifications in 
the cohort. 
‘‘(2) FISCAL REPORT.—For fiscal years 2008 
through 2012, not later than 120 days after the end 
of each fiscal year during which fees are collected 
under this part, the Secretary shall prepare and sub-
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mit to the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representa-
tives, a report on the implementation of the author-
ity for such fees during such fiscal year and the use, 
by the Food and Drug Administration, of the fees 
collected during such fiscal year for which the report 
is made. 
‘‘(3) PUBLIC
AVAILABILITY.—The Secretary 
shall make the reports required under paragraphs 
(1) and (2) available to the public on the Internet 
Web site of the Food and Drug Administration. 
‘‘(b) REAUTHORIZATION.— 
‘‘(1) 
CONSULTATION.—In 
developing 
rec-
ommendations to present to Congress with respect to 
the goals, and plans for meeting the goals, for the 
process for the review of device applications for the 
first 5 fiscal years after fiscal year 2012, and for the 
reauthorization of this part for such fiscal years, the 
Secretary shall consult with— 
‘‘(A) the Committee on Energy and Com-
merce of the House of Representatives; 
‘‘(B) the Committee on Health, Education, 
Labor, and Pensions of the Senate; 
‘‘(C) scientific and academic experts; 
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‘‘(D) health care professionals; 
‘‘(E) representatives of patient and con-
sumer advocacy groups; and 
‘‘(F) the regulated industry. 
‘‘(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-
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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 
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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 
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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 
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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— 
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(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 
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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 
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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 
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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.’’. 
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(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 
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‘‘(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— 
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(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: 
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‘‘(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— 
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‘‘(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— 
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‘‘(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 
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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. 
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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 
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(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. 
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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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