‘‘(b) ADVISORY REVIEW FEE REVENUE AMOUNTS.— 
Fees under subsection (a)(1) shall be established to gen-
erate revenue amounts of $6,250,000 for each of fiscal 
years 2008 through 2012, as adjusted pursuant to sub-
sections (c) and (g)(4). 
‘‘(c) ADJUSTMENTS.— 
‘‘(1) 
INFLATION
ADJUSTMENT.—Beginning 
with fiscal year 2009, the revenues established in 
subsection (b) shall be adjusted by the Secretary by 
notice, published in the Federal Register, for a fiscal 
year to reflect the greater of— 
‘‘(A) the total percentage change that oc-
curred in the Consumer Price Index for all 
urban consumers (all items; U.S. city average), 
for the 12-month period ending June 30 pre-
ceding the fiscal year for which fees are being 
established; 
‘‘(B) the total percentage change for the 
previous fiscal year in basic pay under the Gen-
eral Schedule in accordance with section 5332 
of title 5, United States Code, as adjusted by 
any locality-based comparability payment pur-
suant to section 5304 of such title for Federal 
employees stationed in the District of Columbia; 
or
‘‘(C) the average annual change in the 
cost, per full-time equivalent position of the 
Food and Drug Administration, of all personnel 
compensation and benefits paid with respect to 
such positions for the first 5 fiscal years of the 
previous 6 fiscal years. 
The adjustment made each fiscal year by this sub-
section will be added on a compounded basis to the 
sum of all adjustments made each fiscal year after 
fiscal year 2008 under this subsection. 
‘‘(2) 
WORKLOAD
ADJUSTMENT.—Beginning 
with fiscal year 2009, after the fee revenues estab-
lished in subsection (b) are adjusted for a fiscal year 
for inflation in accordance with paragraph (1), the 
fee revenues shall be adjusted further for such fiscal 
year to reflect changes in the workload of the Sec-
retary with respect to the submission of DTC adver-
tisements for advisory review prior to initial broad-
cast. With respect to such adjustment: 
‘‘(A) The adjustment shall be determined 
by the Secretary based upon the number of 
DTC advertisements identified pursuant to sub-
section (a)(1)(C) for the upcoming fiscal year, 
excluding allowable previously paid carry over 
submissions. The adjustment shall be deter-
mined by multiplying the number of such adver-
tisements projected for that fiscal year that ex-
ceeds 150 by $27,600 (adjusted each year be-
ginning with fiscal year 2009 for inflation in 
accordance with paragraph (1)). The Secretary 
shall publish in the Federal Register the fee 
revenues and fees resulting from the adjust-
ment and the supporting methodologies. 
‘‘(B) Under no circumstances shall the ad-
justment result in fee revenues for a fiscal year 
that are less than the fee revenues established 
for the prior fiscal year. 
‘‘(3) ANNUAL FEE SETTING FOR ADVISORY RE-
VIEW.— 
‘‘(A) IN GENERAL.—Not later than August 
1 of each fiscal year, the Secretary shall estab-
lish for the next fiscal year the DTC advertise-
ment advisory review fee under subsection 
(a)(1), based on the revenue amounts estab-
lished under subsection (b), the adjustments 
provided under paragraphs (1) and (2), and the 
number of DTC advertisements identified pur-
suant to subsection (a)(1)(C), excluding allow-
able previously-paid carry over submissions. 
The annual advisory review fee shall be estab-
lished by dividing the fee revenue for a fiscal 
year (as adjusted pursuant to this subsection) 
by the number of DTC advertisements so iden-
tified, excluding allowable previously-paid carry 
over submissions. 
‘‘(B) FISCAL YEAR 2008 FEE LIMIT.—Not-
withstanding subsection (b) and the adjust-
ments pursuant to this subsection, the fee es-
tablished under subparagraph (A) for fiscal 
year 2008 may not be more than $83,000 per 
submission for advisory review. 
‘‘(C) 
ANNUAL
FEE
LIMIT.—Notwith-
standing subsection (b) and the adjustments 
pursuant to this subsection, the fee established 
under subparagraph (A) for a fiscal year after 
fiscal year 2008 may not be more than 50 per-
cent more than the fee established for the prior 
fiscal year. 
‘‘(D) LIMIT.—The total amount of fees ob-
ligated for a fiscal year may not exceed the 
total costs for such fiscal year for the resources 
allocated for the process for the advisory review 
of prescription drug advertising. 
‘‘(d) OPERATING RESERVES.—
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish in the Food and Drug Administration salaries 
and expenses appropriation account without fiscal 
year limitation a Direct-to-Consumer Advisory Re-
view Operating Reserve, of at least $6,250,000 in 
fiscal year 2008, to continue the program under this 
section in the event the fees collected in any subse-
quent fiscal year pursuant to subsection (a)(1) do 
not generate the fee revenue amount established for 
that fiscal year. 
‘‘(2) FEE SETTING.—The Secretary shall estab-
lish the operating reserve fee under subsection 
(a)(2)(A) for each person required to pay the fee by 
multiplying the number of DTC advertisements iden-
tified by that person pursuant to subsection 
(a)(1)(C) by the advisory review fee established pur-
suant to subsection (c)(3) for that fiscal year, except 
that in no case shall the operating reserve fee as-
sessed be less than the operating reserve fee as-
sessed if the person had first participated in the pro-
gram under this section in fiscal year 2008. 
‘‘(3) USE OF OPERATING RESERVE.—The Sec-
retary may use funds from the reserves only to the 
extent necessary in any fiscal year to make up the 
difference between the fee revenue amount estab-
lished for that fiscal year under subsections (b) and 
(c) and the amount of fees actually collected for that 
fiscal year pursuant to subsection (a)(1), or to pay 
costs of ending the program under this section if it 
is terminated pursuant to subsection (f) or not reau-
thorized beyond fiscal year 2012. 
‘‘(4) REFUND
OF
OPERATING
RESERVES.— 
Within 120 days of the end of fiscal year 2012, or 
if the program under this section ends early pursu-
ant to subsection (f), the Secretary, after setting 
aside sufficient operating reserve amounts to termi-
nate the program under this section, shall refund all 
amounts remaining in the operating reserve on a pro 
rata basis to each person that paid an operating re-
serve fee assessment. In no event shall the refund to 
any person exceed the total amount of operating re-
serve fees paid by such person pursuant to sub-
section (a)(2). 
‘‘(e) EFFECT OF FAILURE TO PAY FEES.—Notwith-
standing any other requirement, a submission for 
prebroadcast advisory review of a DTC advertisement sub-
mitted by a person subject to fees under subsection (a) 
shall be considered incomplete and shall not be accepted 
for review by the Secretary until all fees owed by such 
person under this section have been paid.
‘‘(f) EFFECT OF INADEQUATE FUNDING OF PRO-
GRAM.— 
‘‘(1) INITIAL
FUNDING.—If on November 1, 
2007, or 120 days after enactment of this provision, 
whichever is later, the Secretary has not received at 
least $11,250,000 in advisory review fees and oper-
ating reserve fees combined, the program under this 
section shall not commence and all collected fees 
shall be refunded. 
‘‘(2) LATER FISCAL YEARS.—Beginning in fis-
cal year 2009, if, on November 1 of the fiscal year, 
the combination of the operating reserves, annual fee 
revenues from that fiscal year, and unobligated fee 
revenues from prior fiscal years falls below 
$9,000,000, adjusted for inflation (as described in 
subsection (c)(1)), the program under this section 
shall cease to exist, and the Secretary shall notify all 
participants, retain any money from the unused ad-
visory review fees and the operating reserves needed 
to close down the program under this section, and 
refund the remainder of the unused fees and oper-
ating reserves. To the extent required to close down 
the program under this section, the Secretary shall 
first use unobligated advisory review fee revenues 
from prior fiscal years, then the operating reserves,
and finally, unused advisory review fees from the rel-
evant fiscal year. 
‘‘(g) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN GENERAL.—Fees authorized under sub-
section (a) of this section shall be collected and 
available for obligation only to the extent and in the 
amount provided in advance in appropriations Acts. 
Such fees are authorized to remain available until 
expended. Such sums as may be necessary may be 
transferred from the Food and Drug Administration 
salaries and expenses appropriation account without 
fiscal year limitation to such appropriation account 
for salaries and expenses with such fiscal year limi-
tation. The sums transferred shall be available solely 
for the process for the advisory review of prescrip-
tion drug advertising. 
‘‘(2) 
COLLECTIONS
AND
APPROPRIATION 
ACTS.— 
‘‘(A) IN
GENERAL.—The fees authorized 
by this section— 
‘‘(i) shall be retained in each fiscal 
year in an amount not to exceed the 
amount specified in appropriation Acts, or 
otherwise made available for obligation for 
such fiscal year; and
‘‘(ii) shall be available for obligation 
only if the amounts appropriated as budget 
authority for such fiscal year are sufficient 
to support a number of full-time equivalent 
review employees that is not fewer than the 
number of such employees supported in fis-
cal year 2007. 
‘‘(B) REVIEW EMPLOYEES.—For purposes 
of subparagraph (A)(ii), the term ‘full-time 
equivalent review employees’ means the total 
combined number of full-time equivalent em-
ployees in— 
‘‘(i) the Center for Drug Evaluation 
and Research, Division of Drug Marketing, 
Advertising, and Communications, Food 
and Drug Administration; and 
‘‘(ii) the Center for Biologics Evalua-
tion and Research, Advertising and Pro-
motional Labeling Branch, Food and Drug 
Administration. 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
For each of the fiscal years 2008 through 2012, 
there is authorized to be appropriated for fees under 
this section an amount equal to the total revenue 
amount determined under subsection (b) for the fis-
cal year, as adjusted pursuant to subsection (c) and 
paragraph (4) of this subsection, plus amounts col-
lected for the reserve fund under subsection (d). 
‘‘(4) OFFSET.—Any amount of fees collected 
for a fiscal year under this section that exceeds the 
amount of fees specified in appropriation Acts for 
such fiscal year shall be credited to the appropria-
tion account of the Food and Drug Administration 
as provided in paragraph (1), and shall be sub-
tracted from the amount of fees that would other-
wise be collected under this section pursuant to ap-
propriation Acts for a subsequent fiscal year. 
‘‘(h) DEFINITIONS.—For purposes of this sub-
chapter: 
‘‘(1) The term ‘advisory review’ means review-
ing and providing advisory comments on a proposed 
advertisement prior to its initial public broadcast. 
‘‘(2) The term ‘advisory review fee’ has the 
meaning indicated for such term in subsection 
(a)(1)(D). 
‘‘(3) The term ‘carry over submission’ means a 
submission for an advisory review for which a fee 
was paid in one fiscal year that is submitted for re-
view in the following fiscal year.
‘‘(4) The term ‘direct-to-consumer television ad-
vertisement’ means an advertisement for a prescrip-
tion drug product as defined in section 735(3) in-
tended to be displayed on any television channel for 
less than 3 minutes. 
‘‘(5) The term ‘DTC advertisement’ has the 
meaning indicated for such term in subsection 
(a)(1)(A). 
‘‘(6) The term ‘operating reserve fee’ has the 
meaning indicated for such term in subsection 
(a)(2)(A). 
‘‘(7) The term ‘person’ includes an individual, 
partnership, corporation, and association, and any 
affiliate thereof or successor in interest. 
‘‘(8) The term ‘prebroadcast advisory review’ 
has the meaning indicated for such term in sub-
section (a)(1)(A). 
‘‘(9) The term ‘process for the advisory review 
of prescription drug advertising’ means the activities 
necessary to review and provide advisory comments 
on DTC advertisements prior to public broadcast 
and, to the extent the Secretary has additional staff 
resources available under the program under this 
section that are not necessary for the advisory re-
view of DTC advertisements, the activities necessary
to review and provide advisory comments on other 
proposed advertisements and promotional material 
prior to public broadcast. 
‘‘(10) The term ‘resources allocated for the 
process for the advisory review of prescription drug 
advertising’ means the expenses incurred in connec-
tion with the process for the advisory review of pre-
scription drug advertising for— 
‘‘(A) officers and employees of the Food 
and Drug Administration, contractors of the 
Food and Drug Administration, advisory com-
mittees, and costs related to such officers, em-
ployees, and committees, and to contracts with 
such contractors; 
‘‘(B) management of information, and the 
acquisition, maintenance, and repair of com-
puter resources; 
‘‘(C) leasing, maintenance, renovation, and 
repair of facilities and acquisition, maintenance, 
and repair of fixtures, furniture, scientific 
equipment, and other necessary materials and 
supplies; 
‘‘(D) collection of fees under this section 
and accounting for resources allocated for the
advisory review of prescription drug advertising; 
and 
‘‘(E) closing down the program under this 
section pursuant to subsection (f)(2) if that be-
comes necessary. 
‘‘(11) The term ‘resubmission’ means a subse-
quent submission for advisory review of a direct-to- 
consumer television advertisement that has been re-
vised in response to the Secretary’s comments on an 
original submission. A resubmission may not intro-
duce significant new concepts or creative themes into 
the television advertisement. 
‘‘(12) The term ‘submission for advisory review’ 
means an original submission of a direct-to-con-
sumer television advertisement for which the sponsor 
voluntarily requests advisory comments before the 
advertisement is publicly disseminated.’’. 
SEC. 105. REAUTHORIZATION; REPORTING REQUIREMENTS. 
(a) PERFORMANCE REPORT.—Beginning with fiscal 
year 2008, not later than 120 days after the end of each 
fiscal year for which fees are collected under part 2 of 
subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary 
of Health and Human Services (referred to in this section 
as the ‘‘Secretary’’) shall prepare and submit to the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report concerning 
the progress of the Food and Drug Administration in 
achieving the goals identified in the letters described in 
section 502(4) of the Prescription Drug User Fee Amend-
ments of 2002 (Subtitle A of title V of Public Law 107– 
188) during such fiscal year and the future plans of the 
Food and Drug Administration for meeting the goals. 
(b) FISCAL REPORT.—Beginning with fiscal year 
2008, not later than 120 days after the end of each fiscal 
year for which fees are collected under the part described 
in subsection (a), the Secretary shall prepare and submit 
to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate a report on the 
implementation of the authority for such fees during such 
fiscal year and the use, by the Food and Drug Administra-
tion, of the fees collected for such fiscal year. 
(c) REAUTHORIZATION.— 
(1) 
CONSULTATION.—In 
developing 
rec-
ommendations to present to the Congress with re-
spect to the goals, and plans for meeting the goals, 
for the process for the review of human drug appli-
cations 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; 
(D) health care professionals; 
(E) representatives of patient and con-
sumer advocacy groups; and 
(F) the regulated industry. 
(2) PUBLIC REVIEW OF RECOMMENDATIONS.— 
After negotiations with the regulated industry and 
representatives of patient and consumer advocacy 
groups, 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 rec-
ommendations;
(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. 
(3) TRANSMITTAL
OF
RECOMMENDATIONS.— 
Not later than January 15, 2012, the Secretary 
shall transmit to Congress the revised recommenda-
tions under paragraph (2), 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. 
(4) PUBLIC AVAILABILITY OF MINUTES.—Be-
fore presenting the recommendations developed 
under paragraphs (1) and (2) to the Congress, the 
Secretary shall make publicly available, on the public 
website of the Food and Drug Administration, the 
minutes of all negotiations conducted under para-
graph (1) or (2), as applicable, between the Food 
and Drug Administration and the regulated industry 
and representatives of patient and consumer advo-
cacy groups.
SEC. 106. SUNSET DATES. 
The amendments made by sections 102, 103, and 104 
cease to be effective October 1, 2012. 
TITLE II—MEDICAL DEVICE 
USER FEE AMENDMENTS OF 2007 
SEC. 201. SHORT TITLE; REFERENCES IN TITLE. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Medical Device User Fee Amendments of 2007’’. 
(b) REFERENCES IN ACT.—Except as otherwise spec-
ified, amendments made by this title to a section or other 
provision of law are amendments to such section or other 
provision of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.). 
Subtitle A—Fees Related to 
Medical Devices 
SEC. 211. DEFINITIONS. 
Section 737 (21 U.S.C. 379i) is amended— 
(1) in paragraph (4)— 
(A) in subparagraph (A), by striking ‘‘or 
an efficacy supplement,’’ and inserting ‘‘an effi-
cacy supplement, or a 30-day notice,’’; and 
(B) by adding after subparagraph (E) the 
following: 
‘‘(F) The term ‘30-day notice’ means a supple-
ment to an approved premarket application or pre-
market report under section 515 that is limited to
a request to make modifications to manufacturing 
procedures or methods of manufacture affecting the 
safety and effectiveness of the device.’’; 
(2) by redesignating paragraphs (5), (6), (7), 
and (8) as paragraphs (7), (8), (9), and (11), re-
spectively; 
(3) by inserting after paragraph (4), as amend-
ed by paragraph (1) of this section, the following: 
‘‘(5) The term ‘request for classification infor-
mation’ means a request made under section 513(g) 
for information respecting the class in which a de-
vice has been classified or the requirements applica-
ble to a device. 
‘‘(6) The term ‘annual fee’, with respect to peri-
odic reporting concerning a class III device, means 
the annual fee associated with periodic reports re-
quired by a PMA approval order (as described in 
section 814.82(a)(7) of title 21, Code of Federal 
Regulations (or any successor regulation)).’’; 
(4) in paragraph (9), as so redesignated— 
(A) by striking ‘‘April of the preceding fis-
cal year’’ and inserting ‘‘October of the pre-
ceding fiscal year’’; and 
(B) by striking ‘‘April 2002’’ and inserting 
‘‘October 2001’’;
(5) by inserting after paragraph (9), as so 
amended, the following: 
‘‘(10) The term ‘person’ includes an affiliate 
thereof.’’; and 
(6) by inserting after paragraph (11), as redes-
ignated by paragraph (2) of this section, the fol-
lowing: 
‘‘(12) The term ‘establishment subject to reg-
istration’ means an establishment that is required to 
register with the Secretary under section 510 and is 
one of the following types of establishments: 
‘‘(A) MANUFACTURER.—An establishment 
that makes by any means any article that is a 
device, as defined in section 201(h), including 
an establishment that sterilizes or otherwise 
makes such article for or on behalf of a speci-
fication developer or any other person. 
‘‘(B) 
SINGLE-USE
DEVICE
REPROC-
ESSOR.—An establishment that performs manu-
facturing operations on a single-use device. 
‘‘(C) SPECIFICATION DEVELOPER.—An es-
tablishment that develops specifications for a 
device that is distributed under the establish-
ment’s name but which performs no manufac-
turing, including an establishment that, in addi-
tion to developing specifications, also arranges 
for the manufacturing of devices labeled with 
another establishment’s name by a contract 
manufacturer.’’. 
SEC. 212. AUTHORITY TO ASSESS AND USE DEVICE FEES. 
(a) TYPES OF FEES.— 
(1) IN GENERAL.—The designation and heading 
of paragraph (2) of section 738(a) (21 U.S.C. 
379j(a)(2)) are amended 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), as 
amended by this paragraph, the following: 
‘‘(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, by 
striking ‘‘1.42 percent’’ and inserting ‘‘1.84 
percent’’; 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, the annual fee shall be 
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)(3) 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 by adding after 
clause (iii) the following: 
‘‘(iv) MODULAR APPLICATIONS WITH-
DRAWN BEFORE FIRST ACTION.—The Sec-
retary shall refund 75 percent of the appli-
cation fee paid for a modular application 
submitted under section 515(c)(4) that is 
withdrawn before a second module is sub-
mitted and before a first action on the first 
module. If the modular application is with-
drawn after a second or subsequent module 
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 modules sub-
mitted.’’. 
(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 registration 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), and (e), 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 
less than 12,250. The percentage increase shall 
be the percentage by which the estimate of es-
tablishments submitting fees in fiscal year 2009 
is less than 12,750, but in no case may the per-
centage increase be more than 8.5 percent over 
that specified in subsection (b) for fiscal year 
2010. If the Secretary makes any adjustment 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 adjusted fee for 
fiscal year 2010 increased by 8.5 percent, and 
such fee for fiscal year 2012 is equal to the ad-
justed 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 and 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 and sales were col-
lected. The applicant shall also submit a 
statement signed by the head of the appli-
cant’s firm or by its chief financial officer
that the applicant has submitted certifi-
cations 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 (other than a 30-day notice), or peri-
odic reporting concerning a class III de-
vice; 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)(A)) 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 and 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 and sales were col-
lected. The applicant shall also submit a 
statement signed by the head of the appli-
cant’s firm or by its chief financial officer 
that the applicant has submitted certifi-
cations 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 registration shall be considered in-
complete and shall not be accepted by the Secretary 
until the registration fee under subsection (a)(3) 
owed for the establishment has been paid. Until the 
fee is paid and the registration is complete, the es-
tablishment 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) in paragraph (1)(D)— 
(A) in the matter preceding clause (i), by 
striking ‘‘For fiscal year 2007’’ and inserting
‘‘For fiscal year 2007 and for each subsequent 
year’’; 
(B) in clause (i), by striking ‘‘applicable to 
fiscal year 2007’’ and inserting ‘‘applicable to 
such fiscal year’’; and 
(C) in clause (ii)— 
(i) by striking ‘‘subparagraph (C)’’ 
and inserting ‘‘this subparagraph’’; and 
(ii) by striking ‘‘for fiscal year 2006’’ 
and inserting ‘‘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 subparagraph (C) or (D) 
of paragraph (1) and if at a later date in such fiscal 
year the Secretary may assess such fees, the Sec-
retary may assess and collect such fees, without any 
modification in the rate for premarket applications, 
supplements, premarket reports, premarket notifica-
tion submissions, 30-day notices, requests for classi-
fication information, periodic reporting concerning a 
class III device, and establishment 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. ANNUAL REPORTS. 
Beginning with fiscal year 2008, the Secretary shall 
prepare and submit to the Committee on Energy and 
Commerce of the House of Representatives and the Com-
mittee on Health, Education, Labor, and Pensions of the 
Senate a report concerning— 
(1) the progress of the Food and Drug Admin-
istration in achieving the goals identified in the let-
ters from the Secretary of Health and Human Serv-
ices to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate, as set forth in the Congressional Record during 
such fiscal year, and the future plans of the Food 
and Drug Administration for meeting the goals, not 
later than 60 days after the end of each fiscal year 
during which fees are collected under part 3 of chap-
ter VII of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379i et seq.); and
(2) the implementation of the authority for 
such fees during such fiscal year, and the use, by 
the Food and Drug Administration, of the fees col-
lected during such fiscal year (including a descrip-
tion of the use of such fees for postmarket safety ac-
tivities), not later than 120 days after the end of 
each fiscal year during which fees are collected 
under the medical device user-fee program reauthor-
ized by this title. 
SEC. 214. CONSULTATION. 
(a) IN GENERAL.—In developing recommendations to 
the Congress for the goals and plans for meeting the goals 
for the process for the review of medical device applica-
tions for fiscal years after fiscal year 2012, and for the 
reauthorization of sections 737 and 738 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379i, 379j), 
the Secretary of Health and Human Services (referred to 
in this section as the ‘‘Secretary’’) shall consult with the 
Committee on Energy and Commerce of the House of 
Representatives, the Committee on Health, Education, 
Labor, and Pensions of the Senate, appropriate scientific 
and academic experts, health care professionals, represent-
atives of patient and consumer advocacy groups, and the 
regulated industry.
(b) RECOMMENDATIONS.—The Secretary shall pub-
lish in the Federal Register recommendations under sub-
section (a), after negotiations with the regulated industry 
and patient and consumer advocacy groups; shall present 
such recommendations to the congressional committees 
specified in such subsection; shall hold a meeting at which 
the public may present its views on such recommenda-
tions; and shall provide for a period of 30 days for the 
public to provide written comments on such recommenda-
tions. 
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, $7,100,000 for fiscal year 2008, and for each of 
the fiscal years 2009 through 2012, $7,100,000 increased 
by the amount necessary to offset the effects of inflation 
occurring after October 1, 2007. 
SEC. 216. EFFECTIVE DATE. 
The amendments made by this title shall take effect 
on the date of the enactment of this title, except that fees
shall be assessed for all premarket applications, premarket 
reports, supplements, and premarket notification submis-
sions received on or after October 1, 2007, regardless of 
the date of enactment. 
SEC. 217. SUNSET CLAUSE. 
The amendments made by this title cease to be effec-
tive October 1, 2012, except that section 213 (regarding 
annual 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 ‘‘On or before’’ and inserting 
‘‘(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)(1) Registrations and listings under this section 
(including 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. 
‘‘(2) With regard to any establishment engaged in the 
manufacture, preparation, propagation, compounding, or 
processing of a device, the registration and listing infor-
mation required by this section shall be submitted to the 
Secretary by electronic means, unless the Secretary grants 
a waiver because electronic registration and listing 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, the study under subsection (a) shall con-
sider the Secretary’s evaluation of the respective intended 
uses and technologies of such devices, including the effec-
tiveness of the 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. 
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 labeling of devices to bear a 
unique identifier.’’. 
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), if 
the device 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 that the 
Secretary has by regulation deter-
mined should be subject to such part 
803 in order to protect the public 
health; or 
‘‘(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;’’. 
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—