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; 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00044
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(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. 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00045
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00046
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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’’; 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00047
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(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-
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00048
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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; 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00049
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00050
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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: 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00051
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
‘‘(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-
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00052
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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.— 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00053
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
‘‘(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-
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00054
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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’’. 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00055
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00056
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00057
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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— 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00058
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(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’’; 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00059
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00060
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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: 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00061
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
‘‘(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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00062
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
‘‘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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00063
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00064
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00065
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(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. 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00066
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00067
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00068
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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— 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00069
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
‘‘(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: 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00070
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
‘‘(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-
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00071
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00072
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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— 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00073
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(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: 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00074
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
‘‘(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— 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00075
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
‘‘(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— 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00076
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
‘‘(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 operation 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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00077
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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. 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00078
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
‘‘(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-
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00079
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00080
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(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. 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00081
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(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. 
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’’. 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00082
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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 enactment of this section, 
and annually thereafter, the Secretary shall submit 
to the Committee on Health, Education, Labor, and 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00083
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
Pensions of the Senate and the Committee on En-
ergy 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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00084
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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).’’. 
SEC. 303. MODIFICATION TO HUMANITARIAN DEVICE EX-
EMPTION. 
(a) IN GENERAL.—Section 520(m) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is 
amended— 
(1) in paragraph (3), by striking ‘‘No’’ and in-
serting ‘‘Except as provided in paragraph (6), no’’; 
(2) in paragraph (5)— 
(A) by inserting ‘‘, if the Secretary has 
reason to believe that the requirements of para-
graph (6) are no longer met,’’ after ‘‘public 
health’’; and 
(B) by adding at the end the following: ‘‘If 
the person granted an exemption under para-
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00085
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
graph (2) fails to demonstrate continued com-
pliance with the requirements of this sub-
section, the Secretary may suspend or withdraw 
the exemption from the effectiveness require-
ments of sections 514 and 515 for a humani-
tarian device only after providing notice and an 
opportunity for an informal hearing.’’; and 
(3) by striking paragraph (6) and inserting 
after paragraph (5) the following new paragraphs: 
‘‘(6)(A) Except as provided in subparagraph (D), the 
prohibition in paragraph (3) shall not apply with respect 
to a person granted an exemption under paragraph (2) 
if each of the following conditions apply: 
‘‘(i)(I) The device with respect to which the ex-
emption is granted is intended for the treatment or 
diagnosis of a disease or condition that occurs in pe-
diatric patients or in a pediatric subpopulation, and 
such device is labeled for use in pediatric patients or 
in a pediatric subpopulation in which the disease or 
condition occurs. 
‘‘(II) The device was not previously approved 
under this subsection for the pediatric patients or 
the pediatric subpopulation described in subclause 
(I) prior to the date of enactment of the Pediatric 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00086
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
Medical Device Safety and Improvement Act of 
2007. 
‘‘(ii) During any calendar year, the number of 
such devices distributed during that year does not 
exceed the annual distribution number specified by 
the Secretary when the Secretary grants such ex-
emption. The annual distribution number shall be 
based on the number of individuals affected by the 
disease or condition that such device is intended to 
treat, diagnose, or cure, and of that number, the 
number of individuals likely to use the device, and 
the number of devices reasonably necessary to treat 
such individuals. In no case shall the annual dis-
tribution number exceed the number identified in 
paragraph (2)(A). 
‘‘(iii) Such person immediately notifies the Sec-
retary if the number of such devices distributed dur-
ing any calendar year exceeds the annual distribu-
tion number referred to in clause (ii). 
‘‘(iv) The request for such exemption is sub-
mitted on or before October 1, 2013. 
‘‘(B) The Secretary may inspect the records relating 
to the number of devices distributed during any calendar 
year of a person granted an exemption under paragraph 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00087
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(2) for which the prohibition in paragraph (3) does not 
apply. 
‘‘(C) A person may petition the Secretary to modify 
the annual distribution number specified by the Secretary 
under subparagraph (A)(ii) with respect to a device if ad-
ditional information on the number of individuals affected 
by the disease or condition arises, and the Secretary may 
modify such number but in no case shall the annual dis-
tribution number exceed the number identified in para-
graph (2)(A). 
‘‘(D) If a person notifies the Secretary, or the Sec-
retary determines through an inspection under subpara-
graph (B), that the number of devices distributed during 
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. 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00088
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
‘‘(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-
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) In consultation with the Office of Pediatric 
Therapeutics and the Center for Devices and Radiological 
Health, the Secretary shall provide for an annual review 
by the Pediatric Advisory Committee of all devices de-
scribed in paragraph (6) to ensure that the exemption 
under paragraph (2) remains appropriate for the pediatric 
populations for which it is granted.’’. 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00089
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(b) REPORT.—Not later than January 1, 2012, the 
Comptroller General of the United States shall submit to 
the Committee on Health, Education, Labor, and Pen-
sions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives a report on 
the impact of allowing persons granted an exemption 
under section 520(m)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(m)(2)) with respect to a 
device to profit from such device pursuant to section 
520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as amend-
ed by subsection (a)), including— 
(1) an assessment of whether such section 
520(m)(6) (as amended by subsection (a)) has in-
creased the availability of pediatric devices for condi-
tions that occur in small numbers of children, in-
cluding any increase or decrease in the number of— 
(A) exemptions granted under such section 
520(m)(2) for pediatric devices; and 
(B) applications approved under section 
515 of such Act (21 U.S.C. 360e) for devices 
intended to treat, diagnose, or cure conditions 
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-
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00090
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
mated size of the pediatric patient population for 
each condition or disease; 
(3) the costs of the pediatric devices, based on 
a survey of children’s hospitals; 
(4) the extent to which the costs of such devices 
are covered by health insurance; 
(5) the impact, if any, of allowing profit on ac-
cess to such devices for patients; 
(6) the profits made by manufacturers for each 
device that receives an exemption; 
(7) an estimate of the extent of the use of the 
pediatric devices by both adults and pediatric popu-
lations for a condition or disease other than the con-
dition or disease on the label of such devices; 
(8) recommendations of the Comptroller Gen-
eral of the United States regarding the effectiveness 
of such section 520(m)(6) (as amended by sub-
section (a)) and whether any modifications to such 
section 520(m)(6) (as amended by subsection (a)) 
should be made; 
(9) existing obstacles to pediatric device devel-
opment; and 
(10) an evaluation of the demonstration grants 
described in section 305. 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00091
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(c) GUIDANCE.—Not later than 180 days after the 
date of enactment of this Act, the Commissioner of Food 
and Drugs shall issue guidance for institutional review 
committees on how to evaluate requests for approval for 
devices for which a humanitarian device exemption under 
section 520(m)(2) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360j(m)(2)) has been granted. 
SEC. 304. ENCOURAGING PEDIATRIC MEDICAL DEVICE RE-
SEARCH. 
(a) ACCESS TO FUNDING.—The Director of the Na-
tional Institutes of Health shall designate a contact point 
or office at the National Institutes of Health to help 
innovators and physicians access funding for pediatric 
medical device development. 
(b) PLAN FOR PEDIATRIC MEDICAL DEVICE RE-
SEARCH.— 
(1) IN
GENERAL.—Not later than 180 days 
after the date of enactment of this Act, the Commis-
sioner of Food and Drugs, in collaboration with the 
Director of the National Institutes of Health and the 
Director of the Agency for Healthcare Research and 
Quality, shall submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the 
House of Representatives a plan for expanding pedi-
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00092
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
atric medical device research and development. In 
developing such plan, the Commissioner of Food and 
Drugs shall consult with individuals and organiza-
tions with appropriate expertise in pediatric medical 
devices. 
(2) CONTENTS.—The plan under paragraph (1) 
shall include— 
(A) the current status of federally funded 
pediatric medical device research; 
(B) any gaps in such research, which may 
include a survey of pediatric medical providers 
regarding unmet pediatric medical device needs, 
as needed; and 
(C) a research agenda for improving pedi-
atric medical device development and Food and 
Drug Administration clearance or approval of 
pediatric medical devices, and for evaluating the 
short- and long-term safety and effectiveness of 
pediatric medical devices. 
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 enactment of this Act, the 
Secretary of Health and Human Services shall issue 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00093
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS