IB 
Union Calendar No. 455
107TH CONGRESS 
2D SESSION 
H. R. 3580
[Report No. 107–728] 
To amend the Federal Food, Drug, and Cosmetic Act to make improvements 
in the regulation of medical devices, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 20, 2001
Mr. GREENWOOD (for himself, Ms. ESHOO, Mr. UPTON, Mr. PALLONE, Mr. 
DEUTSCH, Mr. TOWNS, Mr. BRYANT, and Mr. BARTON of Texas) intro-
duced the following bill; which was referred to the Committee on Energy 
and Commerce 
OCTOBER 7, 2002 
Additional sponsors: Mr. PICKERING, Mr. ENGEL, Mr. LUTHER, Mr. 
RAMSTAD, Mr. RUSH, Mr. EHRLICH, Mr. WYNN, Mr. BURR of North 
Carolina, Mrs. ROUKEMA, Mr. PITTS, Mr. WHITFIELD, Mr. NORWOOD, 
Mrs. JOHNSON of Connecticut, Mr. HALL of Texas, Mr. FORD, and Mr. 
KENNEDY of Minnesota 
OCTOBER 7, 2002 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on December 20, 2001] 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
make improvements in the regulation of medical devices, 
and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Medical Device User Fee and Modernization Act of 2002’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows:
Sec. 1. Short title; table of contents. 
TITLE I—FEES RELATED TO MEDICAL DEVICES 
Sec. 101. Findings. 
Sec. 102. Establishment of program. 
Sec. 103. Annual reports. 
Sec. 104. Postmarket surveillance. 
Sec. 105. Consultation. 
Sec. 106. Effective date. 
Sec. 107. Sunset clause. 
TITLE II—AMENDMENTS REGARDING REGULATION OF MEDICAL 
DEVICES 
Sec. 201. Inspections by accredited persons. 
Sec. 202. Third party review of premarket notification. 
Sec. 203. Designation and regulation of combination products. 
Sec. 204. Report on certain devices. 
Sec. 205. Electronic labeling. 
Sec. 206. Electronic registration. 
Sec. 207. Intended use. 
Sec. 208. Modular review. 
Sec. 209. Pediatric expertise regarding classification-panel review of premarket 
applications. 
Sec. 210. Internet list of class II devices exempted from requirement of premarket 
notification. 
Sec. 211. Study by Institute of Medicine of postmarket surveillance regarding pe-
diatric populations. 
Sec. 212. Guidance regarding pediatric devices. 
Sec. 213. Breast implants; study by Comptroller General. 
Sec. 214. Breast implants; research through National Institutes of Health. 
TITLE III—ADDITIONAL AMENDMENTS 
Sec. 301. Identification of manufacturer of medical devices. 
Sec. 302. Single-use medical devices.
TITLE I—FEES RELATED TO 
MEDICAL DEVICES 
SEC. 101. FINDINGS. 
The Congress finds that—
(1) prompt approval and clearance of safe and 
effective devices is critical to the improvement of the 
public health so that patients may enjoy the benefits 
of devices to diagnose, treat, and prevent disease; 
(2) the public health will be served by furnishing 
additional funds for the review of devices so that 
statutorily mandated deadlines may be met; and 
(3) the fees authorized by the amendment made 
by section 102 will be dedicated to meeting the goals 
identified in the letters from the Secretary of Health 
and Human Services to the Committee on Energy 
and Commerce of the House of Representatives and 
the Committee on Health, Education, Labor, and 
Pensions of the Senate. 
SEC. 102. ESTABLISHMENT OF PROGRAM. 
(a) IN GENERAL.—Subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379F et 
seq.) is amended by adding at the end the following part: 
‘‘PART 3—FEES RELATING TO DEVICES 
‘‘SEC. 737. DEFINITIONS. 
‘‘For purposes of this subchapter:
‘‘(1) The term ‘premarket application’ means—
‘‘(A) an application for approval of a de-
vice submitted under section 515(c) or section 
351 of the Public Health Service Act; or 
‘‘(B) a product development protocol de-
scribed in section 515(f). 
Such term does not include a supplement, a pre-
market report, or a premarket notification submis-
sion. 
‘‘(2) The term ‘premarket report’ means a report 
submitted under section 510(o)(3). 
‘‘(3) The term ‘premarket notification submis-
sion’ means a report submitted under section 510(k). 
‘‘(4)(A) The term ‘supplement’, with respect to a 
panel-track supplement, a 180-day supplement, a 
real-time supplement, or an efficacy supplement, 
means a request to the Secretary to approve a change 
in a device for which—
‘‘(i) an application has been approved 
under section 515(d) or under section 351 of the 
Public Health Service Act; or 
‘‘(ii) a notice of completion has become ef-
fective under section 515(f). 
‘‘(B) The term ‘panel-track supplement’ means a 
supplement to an approved premarket application
under section 515 that requests a significant change 
in design or performance of the device, or a new indi-
cation for use of the device, and for which clinical
data are generally necessary to provide a reasonable 
assurance of safety and effectiveness. 
‘‘(C) The term ‘180-day supplement’ means a 
supplement to an approved premarket application 
under section 515 that is not a panel-track supple-
ment and requests a significant change in compo-
nents, materials, design, specification, software, color 
additives, or labeling. 
‘‘(D) The term ‘real-time supplement’ means a 
supplement to an approved premarket application 
under section 515 that requests a minor change to the 
device, such as a minor change to the design of the 
device, software, manufacturing, sterilization, or la-
beling, and for which the applicant has requested and 
the agency has granted a meeting or similar forum to 
jointly review and determine the status of the supple-
ment. 
‘‘(E) The term ‘efficacy supplement’ means a 
supplement to an approved premarket application 
under section 351 of the Public Health Service Act 
that requires substantive clinical data.
‘‘(5) The term ‘process for the review of device 
applications’ means the following activities of the 
Secretary with respect to the review of premarket ap-
plications, premarket reports, supplements, and pre-
market notification submissions: 
‘‘(A) The activities necessary for the review 
of premarket applications, premarket reports, 
supplements, and premarket notification submis-
sions. 
‘‘(B) The issuance of action letters that 
allow the marketing of devices or which set forth 
in detail the specific deficiencies in such applica-
tions, reports, supplements, or submissions and, 
where appropriate, the actions necessary to place 
them in condition for approval. 
‘‘(C) The inspection of manufacturing estab-
lishments and other facilities undertaken as part 
of the Secretary’s review of pending premarket 
applications, premarket reports, and supple-
ments. 
‘‘(D) Monitoring of research conducted in 
connection with the review of such applications, 
reports, supplements, and submissions. 
‘‘(E) Review of device applications subject 
to section 351 of the Public Health Service Act
for an investigational new drug application 
under section 505(i) or for an investigational de-
vice exemption under section 520(g) and activi-
ties conducted in anticipation of the submission 
of such applications under section 505(i) or 
520(g). 
‘‘(F) The development of guidance, policy 
documents, or regulations to improve the process 
for the review of premarket applications, pre-
market reports, supplements, and premarket no-
tification submissions. 
‘‘(G) The development of voluntary test 
methods, consensus standards, or mandatory per-
formance standards under section 514 in connec-
tion with the review of such applications, re-
ports, supplements, or submissions and related 
activities. 
‘‘(H) The provision of technical assistance 
to device manufacturers in connection with the 
submission of such applications, reports, supple-
ments, or submissions. 
‘‘(I) Any activity undertaken under section 
513 or 515(i) in connection with the initial clas-
sification or reclassification of a device or under
section 515(b) in connection with any require-
ment for approval of a device. 
‘‘(J) Evaluation of postmarket studies re-
quired as a condition of an approval of a pre-
market application under section 515 or section 
351 of the Public Health Service Act. 
‘‘(K) Compiling, developing, and reviewing 
information on relevant devices to identify safety 
and effectiveness issues for devices subject to pre-
market applications, premarket reports, supple-
ments, or premarket notification submissions. 
‘‘(6) The term ‘costs of resources allocated for the 
process for the review of device applications’ means 
the expenses incurred in connection with the process 
for the review of device applications for—
‘‘(A) officers and employees of the Food and 
Drug Administration, contractors of the Food 
and Drug Administration, advisory committees, 
and costs related to such officers, employees, and 
committees and to contracts with such contrac-
tors; 
‘‘(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 equip-
ment, and other necessary materials and sup-
plies; and 
‘‘(D) collecting fees and accounting for re-
sources allocated for the review of premarket ap-
plications, premarket reports, supplements, and 
submissions. 
‘‘(7) The term ‘adjustment factor’ applicable to a 
fiscal year is the Consumer Price Index for all urban 
consumers (all items; United States city average) for 
April of the preceding fiscal year divided by such 
Index for April 2002. 
‘‘(8) The term ‘affiliate’ means a business entity 
that has a relationship with a second business entity 
if, directly or indirectly—
‘‘(A) one business entity controls, or has the 
power to control, the other business entity; or 
‘‘(B) a third party controls, or has power to 
control, both of the business entities. 
‘‘SEC. 738. AUTHORITY TO ASSESS AND USE DEVICE FEES. 
‘‘(a) TYPES OF FEES.—Beginning on the date of the 
enactment of the Medical Device User Fee and Moderniza-
tion Act of 2002, the Secretary shall assess and collect fees 
in accordance with this section as follows: 
‘‘(1) PREMARKET APPLICATION, PREMARKET RE-
PORT, SUPPLEMENT, AND SUBMISSION FEE.—
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B) and subsection (d), each per-
son who submits any of the following, on or after 
October 1, 2002, shall be subject to a fee estab-
lished under subsection (c)(5) for the fiscal year 
involved in accordance with the following: 
‘‘(i) A premarket application. 
‘‘(ii) For a premarket report, a fee 
equal to the fee that applies under clause 
(i). 
‘‘(iii) For a panel track supplement, a 
fee equal to the fee that applies under clause 
(i). 
‘‘(iv) For a 180-day supplement, a fee 
equal to 21.5 percent of the fee that applies 
under clause (i), subject to any adjustment 
under subsection (c)(3). 
‘‘(v) For a real-time supplement, a fee 
equal to 7.2 percent of the fee that applies 
under clause (i).
‘‘(vi) For an efficacy supplement, a fee 
equal to the fee that applies under clause 
(i). 
‘‘(vii) For a premarket notification 
submission, a fee equal to 1.75 percent of 
the fee that applies under clause (i), subject 
to any adjustment under subsection (c)(3).
‘‘(B) EXCEPTIONS.—
‘‘(i) HUMANITARIAN
DEVICE
EXEMP-
TION.—A device for which a humanitarian 
device exemption has been granted is not 
subject to the fees established in subpara-
graph (A). 
‘‘(ii) 
FURTHER
MANUFACTURING 
USE.—No fee shall be required under sub-
paragraph (A) for the submission of a pre-
market application under section 351 of the 
Public Health Service Act for a product li-
censed for further manufacturing use only. 
‘‘(iii) STATE
OR
FEDERAL
GOVERN-
MENT SPONSORS.—No fee shall be required 
under subparagraph (A) for a premarket 
application, premarket report, supplement, 
or premarket notification submission sub-
mitted by a State or Federal Government
entity unless the device involved is to be dis-
tributed commercially. 
‘‘(iv) PREMARKET
NOTIFICATIONS
BY 
THIRD PARTIES.—No fee shall be required 
under subparagraph (A) for a premarket 
notification submission reviewed by an ac-
credited person pursuant to section 523. 
‘‘(v) PEDIATRIC CONDITIONS OF USE.—
‘‘(I) IN GENERAL.—No fee shall be 
required under subparagraph (A) for a 
premarket application or premarket 
notification submission if the proposed 
conditions of use for the device involved 
are solely for a pediatric population. 
No fee shall be required under such 
subparagraph for a supplement if the 
sole purpose of the supplement is to 
propose conditions of use for a pedi-
atric population. 
‘‘(II) SUBSEQUENT PROPOSAL OF 
ADULT
CONDITIONS
OF
USE.—In the 
case of a person who submits a pre-
market application for which, under 
subclause (I), a fee under subpara-
graph (A) is not required, any supple-
ment to such application that proposes 
conditions of use for any adult popu-
lation is subject to the fee that applies 
under such subparagraph for a pre-
market application. 
‘‘(C) PAYMENT.—The fee required by sub-
paragraph (A) shall be due upon submission of 
the premarket application, premarket report, 
supplement, or premarket notification submis-
sion except that invoices for applications sub-
mitted between October 1, 2002, and the date of 
the enactment of the Medical Device User Fee 
and Modernization Act of 2002 shall be payable 
on October 30, 2002. Applicants submitting por-
tions 
of 
applications 
pursuant 
to 
section 
515(c)(3) shall pay such fees upon submission of 
the first portion of such applications. The fees 
credited to fiscal year 2003 under this section 
shall include all fees payable from October 1, 
2002, through September 30, 2003. 
‘‘(D) REFUNDS.—
‘‘(i) APPLICATION REFUSED FOR FIL-
ING.—The Secretary shall refund 75 percent 
of the fee paid under subparagraph (A) for
any application or supplement that is re-
fused for filing. 
‘‘(ii) APPLICATION
WITHDRAWN
BE-
FORE FILING.—The Secretary shall refund 
75 percent of the fee paid under subpara-
graph (A) for any application or supple-
ment that is withdrawn prior to the filing 
decision of the Secretary. 
‘‘(iii) APPLICATION
WITHDRAWN
BE-
FORE FIRST ACTION.—After receipt of a re-
quest for a refund of the fee paid under sub-
paragraph (A) for a premarket application, 
premarket report, or supplement that is 
withdrawn after filing but before a first ac-
tion, the Secretary may return some or all 
of the fee. The amount of refund, if any, 
shall be based on the level of effort already 
expended on the review of such application, 
report, or supplement. The Secretary shall 
have sole discretion to refund a fee or por-
tion of the fee under this subparagraph. A 
determination by the Secretary concerning 
a refund under this paragraph shall not be 
reviewable.
‘‘(b) FEE REVENUE AMOUNTS.—Except as provided in 
subsections (c), (d), (f), and (g), the fees under subsection 
(a) shall be established to generate the following revenue 
amounts: $25,125,000 in fiscal year 2003; $27,255,000 in 
fiscal year 2004; $29,785,000 in fiscal year 2005; 
$32,615,000 in fiscal year 2006, and $35,000,000 in fiscal 
year 2007. If legislation is enacted after the date of the en-
actment of this Act requiring the Secretary to fund addi-
tional costs of the retirement of Federal personnel, fee rev-
enue amounts under this subsection shall be increased in 
each year by the amount necessary to fully fund the portion 
of such additional costs that are attributable to the process 
for the review of device applications. 
‘‘(c) ADJUSTMENTS.—
‘‘(1) INFLATION ADJUSTMENT.—The revenues es-
tablished 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 es-
tablished, or
‘‘(B) the total percentage change for the pre-
vious fiscal year in basic pay under the General 
Schedule in accordance with section 5332 of title 
5, United States Code, as adjusted by any local-
ity-based comparability payment pursuant to 
section 5304 of such title for Federal employees 
stationed in the District of Columbia. 
The adjustment made each fiscal year by this sub-
section shall be added on a compounded basis to the 
sum of all adjustments made each fiscal year after fis-
cal year 2003 under this subsection. 
‘‘(2) WORKLOAD
ADJUSTMENT.—After the fee 
revenues established in subsection (b) are adjusted for 
a fiscal year for inflation in accordance with para-
graph (1), the fee revenues shall, beginning with fiscal 
year 2004, be adjusted further each fiscal year to re-
flect changes in the workload of the Secretary for the 
process for the review of device applications. With re-
spect to such adjustment: 
‘‘(A) The adjustment shall be determined by 
the Secretary based on a weighted average of the 
change in the total number of premarket appli-
cations, investigational new device applications, 
premarket reports, supplements, and premarket 
notification submissions submitted to the Sec-
retary. The Secretary shall publish in the Fed-
eral Register the fee revenues and fees resulting 
from the adjustment and the supporting meth-
odologies. 
‘‘(B) Under no circumstances shall the ad-
justment result in fee revenues for a fiscal year 
that are less than the fee revenues for the fiscal 
year established in subsection (b), as adjusted for 
inflation under paragraph (1).
‘‘(3) COMPENSATING ADJUSTMENT.—After the fee 
revenues established in subsection (b) are adjusted for 
a fiscal year for inflation in accordance with para-
graph (1), and for workload in accordance with para-
graph (2), the fee revenues shall, beginning with fiscal 
year 2004, be adjusted further each fiscal year, if nec-
essary, to reflect the cumulative amount by which col-
lections for previous fiscal years, beginning with fis-
cal year 2003, fell below the cumulative revenue 
amounts for such fiscal years specified in subsection 
(b), adjusted for such fiscal years for inflation in ac-
cordance with paragraph (1), and for workload in ac-
cordance with paragraph (2). Only fees for 180 day 
supplements and premarket notification submissions 
shall be increased to generate compensating adjust-
ment revenues.
‘‘(4) FINAL YEAR ADJUSTMENT.—For fiscal year 
2007, the Secretary may, in addition to adjustments 
under paragraphs (1) and (2), further increase the 
fees and fee revenues established in subsection (b) if 
such adjustment is necessary to provide for not more 
than three months of operating reserves of carryover 
user fees for the process for the review of device appli-
cations for the first three months of fiscal year 2008. 
If such an adjustment is necessary, the rationale for 
the amount of the increase shall be contained in the 
annual notice establishing fee revenues and fees for 
fiscal year 2007. If the Secretary has carryover user 
fee balances for such process in excess of three months 
of such operating reserves, the adjustment under this 
paragraph shall not be made. 
‘‘(5) ANNUAL
FEE
SETTING.—The Secretary 
shall, 60 days before the start of each fiscal year after 
September 30, 2002, establish, for the next fiscal year, 
and publish in the Federal Register, fees under sub-
section (a), based on the revenue amounts established 
under subsection (b) and the adjustment provided 
under this subsection, except that the fees established 
for fiscal year 2003 shall be based on a premarket ap-
plication fee of $139,000.
‘‘(6) LIMIT.—The total amount of fees charged, 
as adjusted under this subsection, for a fiscal year 
may not exceed the total costs for such fiscal year for 
the resources allocated for the process for the review 
of device applications. 
‘‘(d) SMALL BUSINESS FEE WAIVER AND FEE REDUC-
TION.—
‘‘(1) IN GENERAL.—The Secretary shall grant a 
waiver of the fee required under subsection (a) for one 
premarket application, or one premarket report, 
where the Secretary finds that the applicant involved 
is a small business submitting its first premarket ap-
plication to the Secretary, or its first premarket re-
port, respectively, for review. In addition, for subse-
quent premarket applications, premarket reports, and 
supplements where the Secretary finds that the appli-
cant involved is a small business, the fees specified in 
clauses (i) through (vi) of subsection (a)(1)(A) may be 
paid at a reduced rate in accordance with paragraph 
(2)(C). 
‘‘(2) RULES RELATING TO SMALL BUSINESSES.—
‘‘(A) DEFINITION.—
‘‘(i) For purposes of this subsection, the 
term ‘small business’ means an entity that 
reported $10,000,000 or less of gross receipts
or sales in its most recent Federal income 
tax return for a taxable year, including 
such returns of all of its affiliates, partners, 
or parent firms. 
‘‘(ii) The Secretary may adjust the 
$10,000,000 threshold established in clause 
(i) if the Secretary has evidence from actual 
experience that this threshold results in a 
reduction in revenues from premarket ap-
plications, premarket reports, and supple-
ments that is 13 percent or more than 
would occur without small business exemp-
tions and lower fee rates. To adjust this 
threshold, the Secretary shall publish a no-
tice in the Federal Register setting out the 
rationale for the adjustment, and the new 
threshold. 
‘‘(B) EVIDENCE
OF
QUALIFICATION.—An 
applicant shall pay the higher fees established by 
the Secretary each year unless the applicant sub-
mits evidence that it qualifies for a waiver of the 
fee or the lower fee rate. The applicant shall sup-
port its claim that it meets the definition under 
subparagraph (A) by submission of a copy of its 
most recent Federal income tax return for a tax-
subsection (c)(5) for a premarket notification 
submission. 
‘‘(D) REQUEST FOR FEE WAIVER OR RE-
DUCTION.—An applicant seeking a fee waiver or 
reduction under this subsection shall submit sup-
porting information to the Secretary at least 60 
days before the fee is required pursuant to sub-
section (a). 
‘‘(e) EFFECT OF FAILURE TO PAY FEES.—A pre-
market application, premarket report, supplement, or pre-
market notification submission submitted by a person sub-
ject to fees under subsection (a) shall be considered incom-
plete and shall not be accepted for filing by the Secretary 
until all fees owed by such person have been paid. 
‘‘(f) CONDITIONS.—
‘‘(1) PERFORMANCE
GOALS
THROUGH
FISCAL 
YEAR 2005; TERMINATION OF PROGRAM AFTER FISCAL 
YEAR 2005.—With respect to the amount that, under 
the salaries and expenses account of the Food and 
Drug Administration, is appropriated for a fiscal 
year for devices and radiological products: 
‘‘(A)(i) For each of the fiscal years 2003 
and 2004, the Secretary is expected to meet all 
of the goals identified for the fiscal year involved 
in any letter referred to in section 101(3) of the
Medical Device User Fee and Modernization Act 
of 2002 (referred to in this paragraph as ‘per-
formance goals’) if the amount so appropriated 
for such fiscal year, excluding the amount of fees 
appropriated for such fiscal year, is equal to or 
greater than $205,720,000 multiplied by the ad-
justment factor applicable to the fiscal year. 
‘‘(ii) For each of the fiscal years 2003 and 
2004, if the amount so appropriated for the fis-
cal year involved, excluding the amount of fees 
appropriated for such fiscal year, is less than the
amount that applies under clause (i) for such fis-
cal year, the following applies: 
‘‘(I) The Secretary is expected to meet 
such goals to the extent practicable, taking 
into account the amounts that are available 
to the Secretary for such purpose, whether 
from fees under subsection (a) or otherwise. 
‘‘(II) The Comptroller General of the 
United States shall submit to the Congress 
a report describing whether and to what ex-
tent the Secretary is meeting the perform-
ance goals identified for such fiscal year, 
and whether the Secretary will be able to 
meet all performance goals identified for fis-
cal year 2005. A report under the preceding 
sentence shall be submitted to the Congress 
not later than July 1 of the fiscal year with 
which the report is concerned. 
‘‘(B)(i) For fiscal year 2005, the Secretary 
is expected to meet all of the goals identified for 
the fiscal year if the total of the amounts so ap-
propriated for fiscal years 2003 through 2005, 
excluding the amount of fees appropriated for 
such fiscal years, is equal to or greater than the 
sum of—
‘‘(I) $205,720,000 multiplied by the 
adjustment factor applicable to fiscal year 
2003; 
‘‘(II) $205,720,000 multiplied by the 
adjustment factor applicable to fiscal year 
2004; and 
‘‘(III) $205,720,000 multiplied by the 
adjustment factor applicable to fiscal year 
2005. 
‘‘(ii) For fiscal year 2005, if the total of the 
amounts so appropriated for fiscal years 2003 
through 2005, excluding the amount of fees ap-
propriated for such fiscal years, is less than the
sum that applies under clause (i) for fiscal year 
2005, the following applies: 
‘‘(I) The Secretary is expected to meet 
such goals to the extent practicable, taking 
into account the amounts that are available 
to the Secretary for such purpose, whether 
from fees under subsection (a) or otherwise. 
‘‘(II) The Comptroller General of the 
United States shall submit to the Congress 
a report describing whether and to what ex-
tent the Secretary is meeting the perform-
ance goals identified for such fiscal year, 
and whether the Secretary will be able to 
meet all performance goals identified for fis-
cal year 2006. The report under the pre-
ceding sentence shall be submitted to the 
Congress not later than July 1, 2005. 
‘‘(C) For fiscal year 2006, fees may not be 
assessed under subsection (a) for the fiscal year, 
and the Secretary is not expected to meet any 
performance goals identified for the fiscal year, 
if the total of the amounts so appropriated for 
fiscal years 2003 through 2006, excluding the 
amount of fees appropriated for such fiscal 
years, is less than the sum of—
‘‘(i) $205,720,000 multiplied by the 
adjustment factor applicable to fiscal year 
2006; and 
‘‘(ii) an amount equal to the sum that 
applies for purposes of subparagraph (B)(i). 
‘‘(D) For fiscal year 2007, fees may not be 
assessed under subsection (a) for the fiscal year, 
and the Secretary is not expected to meet any 
performance goals identified for the fiscal year, 
if—
‘‘(i) the amount so appropriated for 
the fiscal year, excluding the amount of fees 
appropriated for the fiscal year, is less than 
$205,720,000 multiplied by the adjustment 
factor applicable to fiscal year 2007; or 
‘‘(ii) pursuant to subparagraph (C), 
fees were not assessed under subsection (a) 
for fiscal year 2006. 
‘‘(2) AUTHORITY.—If the Secretary does not as-
sess 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 Secretary 
may assess and collect such fees, without any modi-
fication in the rate for premarket applications, sup-
‘‘(ii) shall only be collected and avail-
able to defray increases in the costs of the 
resources allocated for the process for the re-
view of device applications (including in-
creases in such costs for an additional num-
ber of full-time equivalent positions in the 
Department of Health and Human Services 
to be engaged in such process) over such 
costs, excluding costs paid from fees col-
lected under this section, for fiscal year 
2002 multiplied by the adjustment factor. 
‘‘(B) COMPLIANCE.—The Secretary shall be 
considered to have met the requirements of sub-
paragraph (A)(ii) in any fiscal year if the costs 
funded by appropriations and allocated for the 
process for the review of device applications—
‘‘(i) are not more than 3 percent below 
the level specified in subparagraph (A)(ii); 
or 
‘‘(ii)(I) are more than 3 percent below 
the level specified in subparagraph (A)(ii), 
and fees assessed for a subsequent fiscal year 
are decreased by the amount in excess of 3 
percent by which such costs fell below the 
level specified in such subparagraph; and
‘‘(II) such costs are not more than 5 
percent below the level specified in such sub-
paragraph. 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.—
There are authorized to be appropriated for fees under 
this section—
‘‘(A) $25,125,000 for fiscal year 2003; 
‘‘(B) $27,255,000 for fiscal year 2004; 
‘‘(C) $29,785,000 for fiscal year 2005; 
‘‘(D) $32,615,000 for fiscal year 2006; and 
‘‘(E) $35,000,000 for fiscal year 2007,
as adjusted to reflect adjustments in the total fee reve-
nues made under this section and changes in the total 
amounts collected by application fees. 
‘‘(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 appropriation 
account of the Food and Drug Administration as pro-
vided in paragraph (1), and shall be subtracted from 
the amount of fees that would otherwise be authorized 
to be collected under this section pursuant to appro-
priation Acts for a subsequent fiscal year. 
‘‘(h) COLLECTION OF UNPAID FEES.—In any case 
where the Secretary does not receive payment of a fee as-
sessed under subsection (a) within 30 days after it is due, 
such fee shall be treated as a claim of the United States 
Government subject to subchapter II of chapter 37 of title 
31, United States Code. 
‘‘(i) WRITTEN REQUESTS FOR REFUNDS.—To qualify 
for consideration for a refund under subsection (a)(1)(D), 
a person shall submit to the Secretary a written request 
for such refund not later than 180 days after such fee is 
due. 
‘‘(j) CONSTRUCTION.—This section may not be con-
strued to require that the number of full-time equivalent 
positions in the Department of Health and Human Serv-
ices, for officers, employees, and advisory committees not 
engaged in the process of the review of device applications, 
be reduced to offset the number of officers, employees, and 
advisory committees so engaged.’’. 
(b) FEE EXEMPTION FOR CERTAIN ENTITIES SUBMIT-
TING PREMARKET REPORTS.—
(1) IN GENERAL.—A person submitting a pre-
market report to the Secretary of Health and Human 
Services is exempt from the fee under section 
738(a)(1)(A)(ii) of the Federal Food, Drug, and Cos-
metic Act (as added by subsection (a) of this section) 
if—
(A) the premarket report is the first such re-
port submitted to the Secretary by the person; 
and 
(B) before October 1, 2002, the person sub-
mitted a premarket application to the Secretary 
for the same device as the device for which the 
person is submitting the premarket report. 
(2) DEFINITIONS.—For purposes of paragraph 
(1), the terms ‘‘device’’, ‘‘premarket application’’, and 
‘‘premarket report’’ have the same meanings as apply 
to such terms for purposes of section 738 of the Fed-
eral Food, Drug, and Cosmetic Act (as added by sub-
section (a) of this section). 
SEC. 103. ANNUAL REPORTS. 
Beginning with fiscal year 2003, the Secretary shall 
prepare and submit to the Committee on Energy and Com-
merce of the House of Representatives and the Committee 
on Health, Education, Labor and Pensions of the Senate 
a report concerning—
(1) the progress of the Food and Drug Adminis-
tration in achieving the goals identified in the letters 
described in section 101(3) during such fiscal year 
and the future plans of the Food and Drug Adminis-
tration for meeting the goals, not later than 60 days
after the end of each fiscal year during which fees are 
collected under this part; 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 collected during 
such fiscal year, not later than 120 days after the end 
of each fiscal year during which fees are collected 
under the medical device user-fee program established 
under the amendment made by section 102. 
SEC. 104. POSTMARKET SURVEILLANCE. 
(a) ADDITIONAL
AUTHORIZATION
OF
APPROPRIA-
TIONS.—For the purpose of carrying out postmarket sur-
veillance of medical devices, there are authorized to be ap-
propriated to the Food and Drug Administration the fol-
lowing amounts, stated as increases above the amount obli-
gated for such purpose by such Administration for fiscal 
year 2002: 
(1) For fiscal year 2003, an increase of 
$3,000,000. 
(2) For fiscal year 2004, an increase of 
$6,000,000. 
(3) For fiscal year 2005 and each subsequent fis-
cal year, an increase of such sums as may be nec-
essary. 
(b) STUDY.—
(1) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the 
‘‘Secretary’’) shall conduct a study for the purpose of 
determining the following with respect to the medical 
device user-fee program established under the amend-
ment made by section 102: 
(A) The impact of such program on the 
ability of the Food and Drug Administration to 
conduct postmarket surveillance on medical de-
vices. 
(B) The programmatic improvements, if 
any, needed for adequate postmarket surveillance 
of medical devices. 
(C) The amount of funds needed to conduct 
adequate postmarket surveillance of medical de-
vices. 
(D) The extent to which device companies 
comply with the postmarket surveillance require-
ments, including postmarket study commitments. 
(E) The recommendations of the Secretary 
as to whether, and in what amounts, user fees 
collected under such user-fee program should be 
dedicated to postmarket surveillance if the pro-
gram is extended beyond fiscal year 2007.
(2) REPORT.—Not later than January 10, 2007, 
the Secretary shall submit to the Committee on En-
ergy and Commerce of the House of Representatives, 
and the Committee on Health, Education, Labor, and 
Pensions of the Senate, a report that describes the 
findings of the study under paragraph (1). 
SEC. 105. 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 applications 
for fiscal years after fiscal year 2007, and for the reauthor-
ization of sections 737 and 738 of the Federal Food, Drug, 
and Cosmetic Act, 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, 
representatives of patient and consumer advocacy groups, 
and the regulated industry. 
(b) RECOMMENDATIONS.—The Secretary shall publish 
in the Federal Register recommendations under subsection 
(a), after negotiations with the regulated industry; shall 
present such recommendations to the congressional commit-
tees specified in such paragraph; shall hold a meeting at
which the public may present its views on such rec-
ommendations; and shall provide for a period of 30 days 
for the public to provide written comments on such rec-
ommendations. 
SEC. 106. EFFECTIVE DATE. 
The amendments made by this title shall take effect 
on the date of the enactment of this Act, except that fees 
shall be assessed for all premarket applications, premarket 
reports, supplements, and premarket notification submis-
sions received on or after October 1, 2002, regardless of the 
date of enactment.
SEC. 107. SUNSET CLAUSE. 
The amendments made by this title cease to be effective 
October 1, 2007, except that section 103 with respect to an-
nual reports ceases to be effective January 31, 2008. 
TITLE 
II—AMENDMENTS 
RE-
GARDING 
REGULATION 
OF 
MEDICAL DEVICES 
SEC. 201. INSPECTIONS BY ACCREDITED PERSONS. 
(a) IN GENERAL.—Section 704 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 374) is amended by 
adding at the end the following subsection: 
‘‘(g)(1) Not later than one year after the date of the 
enactment of this subsection, the Secretary shall, subject to 
the provisions of this subsection, accredit persons who are
not Federal employees for the purpose of conducting the in-
spections required in section 510(h), or pursuant to section 
510(i), for establishments that manufacture, prepare, prop-
agate, compound, or process class II or class III devices. 
The owner or operator of such an establishment that is eligi-
ble under paragraph (6) may, from the list published under 
paragraph (4), select an accredited person to conduct such 
inspections. 
‘‘(2) Not later than 180 days after the date of enact-
ment of this subsection, the Secretary shall publish in the 
Federal Register criteria to accredit or deny accreditation 
to persons who request to perform the duties specified in 
paragraph (1). Thereafter, the Secretary shall inform those 
requesting accreditation, within 60 days after the receipt 
of such request, whether the request for accreditation is ade-
quate for review, and the Secretary shall promptly act on 
the request for accreditation. Any resulting accreditation 
shall state that such person is accredited to conduct inspec-
tions at establishments identified in paragraph (1). The ac-
creditation of such person shall specify the particular ac-
tivities under this subsection for which such person is ac-
credited. In the first year following the publication in the 
Federal Register of criteria to accredit or deny accredita-
tion to persons who request to perform the duties specified 
in paragraph (1), the Secretary shall accredit no more than
15 persons who request to perform duties specified in para-
graph (1). 
‘‘(3) An accredited person shall, at a minimum, meet 
the following requirements: 
‘‘(A) Such person shall be an independent orga-
nization which is not owned or controlled by a manu-
facturer, supplier, or vendor of articles regulated 
under this Act and which has no organizational, ma-
terial, or financial affiliation (including a consult-
ative affiliation) with such a manufacturer, supplier, 
or vendor. 
‘‘(B) Such person shall be a legally constituted 
entity permitted to conduct the activities for which it 
seeks accreditation. 
‘‘(C) Such person shall not engage in the design, 
manufacture, promotion, or sale of articles regulated 
under this Act. 
‘‘(D) The operations of such person shall be in 
accordance with generally accepted professional and 
ethical business practices, and such person shall agree 
in writing that at a minimum the person will—
‘‘(i) certify that reported information accu-
rately reflects data reviewed; 
‘‘(ii) limit work to that for which com-
petence and capacity are available;
‘‘(iii) treat information received, records, 
reports, and recommendations as confidential 
commercial or financial information or trade se-
cret information; 
‘‘(iv) promptly respond and attempt to re-
solve complaints regarding its activities for 
which it is accredited; and 
‘‘(v) protect against the use, in carrying out 
paragraph (1), of any officer or employee of the 
accredited person who has a financial conflict of 
interest regarding any product regulated under 
this Act, and annually make available to the 
public disclosures of the extent to which the ac-
credited person, and the officers and employees of 
the person, have maintained compliance with re-
quirements under this clause relating to finan-
cial conflicts of interest. 
‘‘(4) The Secretary shall publish on the Internet site 
of the Food and Drug Administration a list of accredited 
persons to conduct inspections under paragraph (1). Such 
list shall be periodically updated to ensure that the identity 
of each accredited person is known to the public. The updat-
ing of such list shall be no later than one month after the 
accreditation of a person under this subsection or the with-
drawal of accreditation.
‘‘(5)(A) To ensure that persons accredited under this 
subsection continue to meet the standards of accreditation, 
the Secretary shall audit the performance of such persons 
on a periodic basis through the review of inspection reports 
and inspections by persons designated by the Secretary to 
evaluate the compliance status of an establishment and the 
performance of accredited persons. 
‘‘(B) The Secretary may withdraw accreditation of 
any person accredited under paragraph (2), after providing 
notice and an opportunity for an informal hearing, when 
such person is substantially not in compliance with the 
standards of accreditation or poses a threat to public health 
or fails to act in a manner that is consistent with the pur-
poses of this subsection. The Secretary may suspend the ac-
creditation of such person during the pendency of the proc-
ess under the preceding sentence. 
‘‘(6)(A) Subject to subparagraphs (B) through (C), a 
device establishment is eligible for inspections by persons 
accredited under paragraph (2) if—
‘‘(i) the Secretary classified the results of the 
most recent inspection of the establishment pursuant 
to subsection (h) or (i) of section 510 as ‘no action 
indicated’ or ‘voluntary action indicated’; and 
‘‘(ii) with respect to each inspection to be con-
ducted by an accredited person—
‘‘(I) the owner or operator of the establish-
ment submits to the Secretary a notice request-
ing clearance to use such a person to conduct the 
inspection, and the Secretary provides such 
clearance; and 
‘‘(II) such notice identifies the accredited 
person whom the establishment has selected to 
conduct the inspection, and the Secretary agrees 
to the selected accredited person. 
‘‘(B)(i) The Secretary shall respond to a notice under 
subparagraph (A) from an establishment not later than 30
days after the Secretary receives the notice. Through such 
response, the Secretary shall (I) provide clearance under 
such subparagraph, and agree to the selection of an accred-
ited person, or (II) make a request under clause (ii). If the 
Secretary fails to respond to the notice within such 30-day 
period, the establishment is deemed to have such clearance, 
and to have the agreement of the Secretary for such selec-
tion. 
‘‘(ii) The request referred to in clause (i)(II) is—
‘‘(I) a request to the establishment involved to 
submit to the Secretary compliance data in accord-
ance with clause (iii); or 
‘‘(II) a request to the establishment, or to the ac-
credited person identified in the notice under sub-
paragraph (A), for information concerning the rela-
tionship between the establishment and such accred-
ited person. 
The Secretary may make both such requests. 
‘‘(iii) The compliance data to be submitted by an es-
tablishment under clause (ii) are data describing whether 
the quality controls of the establishment have been sufficient 
for ensuring consistent compliance with current good man-
ufacturing practice within the meaning of section 501(h), 
and data otherwise describing whether the establishment has 
consistently been in compliance with sections 501 and 502 
and other applicable provisions of this Act. Such data shall 
include complete reports of inspections regarding good man-
ufacturing practice or other quality control audits that, 
during the preceding two-year period, were conducted at the 
establishment by persons other than the owner or operator 
of the establishment, together with all other data the Sec-
retary deems necessary. Data under the preceding sentence 
shall demonstrate to the Secretary whether the establishment 
has facilitated consistent compliance by promptly cor-
recting any compliance problems identified in such inspec-
tions. 
‘‘(iv) Not later than 60 days after receiving compliance 
data under clause (iii) from an establishment, the Secretary 
shall provide or deny clearance under subparagraph (A).
The Secretary may not deny clearance unless the Secretary 
provides to the establishment detailed findings that the es-
tablishment has failed to demonstrate consistent compliance 
for purposes of clause (iii). If the Secretary fails to provide 
such findings to the establishment within such 60-day pe-
riod, the establishment is deemed to have such clearance. 
‘‘(v)(I) 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 subsection 
(f)(1). Not later than 60 days after receiving the informa-
tion sought by the request, the Secretary shall agree to, or 
reject, the selection of such person by the establishment in-
volved. The Secretary may not reject the selection unless the 
Secretary provides to the establishment the reasons for such 
rejection. Reasons for the rejection may include that the es-
tablishment or the accredited person, as the case may be, 
has failed to fully respond to the request. If within such 
60-day period the Secretary fails to agree to or reject the 
selection in accordance with this subclause, the Secretary 
is deemed to have agreed to the selection. 
‘‘(II) If the Secretary rejects the selection of an accred-
ited person by an establishment, the establishment may 
make an additional selection of an accredited person by 
submitting to the Secretary a notice that identifies the addi-
tional selection. Clauses (i) and (ii), 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 provisions apply 
to a selection of an accredited person through a notice under 
subparagraph (A). 
‘‘(vi) In the case of an establishment that under clause 
(iv) is denied clearance under subparagraph (A), or whose 
selection of an accredited person is rejected under clause (v), 
the Secretary shall designate a person to review the findings 
of the Secretary under such clause if, during the 30-day 
period beginning on the date on which the establishment 
receives the findings, the establishment requests the review. 
The review shall commence not later than 30 days after the 
establishment requests the review, unless the Secretary and 
the establishment otherwise agree. 
‘‘(C)(i) In the case of a device establishment for which 
the Secretary classified the results of the most recent inspec-
tion of the establishment by a person accredited under para-
graph (2) as ‘official action indicated’, the establishment 
is eligible for further inspections by persons accredited 
under such paragraph if (I) the Secretary issues a written 
statement to the owner or operator of the establishment that 
the violations leading to such classification have been re-
solved, and (II) the Secretary, either upon the Secretary’s 
own initiative or a petition of the owner or operator of the
establishment, notifies the establishment that it has clear-
ance to use an accredited person for the inspections. The 
Secretary shall respond to such petition within 30 days 
after the receipt of the petition. 
‘‘(ii) If the Secretary denies a petition under clause 
(i), the establishment involved may, after the expiration of 
one year after such denial, again petition the Secretary for 
a determination of eligibility for inspection by persons ac-
credited by the Secretary under paragraph (2). If the Sec-
retary denies such petition, the Secretary shall provide the 
establishment with a detailed reason for such denial within 
60 days after the denial. If, as of the expiration of 48 
months after the receipt of the first petition, the establish-
ment has not been inspected by the Secretary in accordance 
with section 510(h), or has not during such period been in-
spected pursuant to section 510(i), as applicable, the estab-
lishment is eligible for further inspections by accredited per-
sons. 
‘‘(7)(A) Persons accredited under paragraph (2) to 
conduct inspections shall record in writing their inspection 
observations and shall present the observations to the device 
establishment’s designated representative and discuss each 
observation. Additionally, such accredited person shall pre-
pare an inspection report (including for inspections classi-
fied as ‘no action indicated’) in a form and manner con-
sistent with such reports prepared by employees and offi-
cials designated by the Secretary to conduct inspections. 
‘‘(B) At a minimum, an inspection report under sub-
paragraph (A) shall identify the persons responsible for 
good manufacturing practice compliance at the inspected 
establishment involved, the dates of the inspection, the scope 
of the inspection, and shall discuss in detail each observa-
tion identified by the accredited person, identify other mat-
ters that relate to or may influence compliance with this 
Act, and discuss any recommendations during the inspec-
tion or at the inspection’s closing meeting.
‘‘(C) An inspection report under subparagraph (A) 
shall be sent to the Secretary and the designated representa-
tive of the inspected establishment involved at the same 
time, but under no circumstances later than three weeks 
after the last day of the inspection. The report to the Sec-
retary shall be accompanied by all written inspection obser-
vations previously provided to the representative of the es-
tablishment. 
‘‘(D) Any statements or representations made by em-
ployees or agents of a device establishment to persons ac-
credited under paragraph (2) to conduct inspections shall 
be subject to section 1001 of title 18, United States Code. 
‘‘(E) If at any time during an inspection by an ac-
credited person the accredited person discovers a condition
that could cause or contribute to an unreasonable risk to 
the public health, the accredited person shall immediately 
notify the Secretary of the identification of the facility sub-
ject to inspection and the conditions of concern. 
‘‘(8) Compensation for an accredited person shall be 
determined by agreement between the accredited person and 
the person who engages the services of the accredited person, 
and shall be paid by the person who engages such services. 
‘‘(9) Nothing in this subsection affects the authority 
of the Secretary to inspect establishments pursuant to this 
Act. 
‘‘(10)(A) For fiscal year 2005 and subsequent fiscal 
years, no device establishment may be inspected during the 
fiscal year involved by a person accredited under paragraph 
(2) if—
‘‘(i) of the amounts appropriated for salaries 
and expenses of the Food and Drug Administration 
for the preceding fiscal year (referred to in this sub-
paragraph as the ‘first prior fiscal year’), the amount 
obligated by the Secretary for inspections of device es-
tablishments by the Secretary was less than the ad-
justed base amount applicable to such first prior fis-
cal year; and 
‘‘(ii) of the amounts appropriated for salaries 
and expenses of the Food and Drug Administration
for the fiscal year preceding the first prior fiscal year 
(referred to in this subparagraph as the ‘second prior 
fiscal year’), the amount obligated by the Secretary 
for inspections of device establishments by the Sec-
retary was less than the adjusted base amount appli-
cable to such second prior fiscal year. 
‘‘(B)(i) Subject to clause (ii), the Comptroller General 
of the United States shall determine the amount that was 
obligated by the Secretary for fiscal year 2002 for compli-
ance activities of the Food and Drug Administration with 
respect to devices (referred to in this subparagraph as the 
‘compliance budget’), and of such amount, the amount that 
was obligated for inspections by the Secretary of device es-
tablishments (referred to in this subparagraph as the ‘in-
spection budget’). 
‘‘(ii) For purposes of determinations under clause (i), 
the Comptroller General shall not include in the compliance 
budget or the inspection budget any amounts obligated for 
inspections of device establishments conducted as part of the 
process of reviewing applications under section 515. 
‘‘(iii) Not later than March 31, 2003, the Comptroller 
General shall complete the determinations required in this 
subparagraph and submit to the Secretary and the Congress 
a reporting describing the findings made through such de-
terminations.
‘‘(C) For purposes of this paragraph: 
‘‘(i) The term ‘base amount’ means the inspec-
tion budget determined under subparagraph (B) for 
fiscal year 2002. 
‘‘(ii) The term ‘adjusted base amount’, in the 
case of applicability to fiscal year 2003, means an 
amount equal to the base amount increased by 5 per-
cent. 
‘‘(iii) The term ‘adjusted base amount’, with re-
spect to applicability to fiscal year 2004 or any sub-
sequent fiscal year, means the adjusted based amount 
applicable to the preceding year increased by 5 per-
cent. 
‘‘(11) The authority provided by this subsection termi-
nates on October 1, 2012. 
‘‘(12) No later than four years after the enactment of 
this subsection the Comptroller General shall report to the 
Committee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, 
Labor and Pensions of the Senate—
‘‘(A) the number of inspections conducted by ac-
credited persons and the number of inspections pursu-
ant to subsections (h) and (i) of section 510 conducted 
by Federal employees;
‘‘(B) the number of persons who sought accredi-
tation under this subsection, as well as the number of 
persons who were accredited under this subsection; 
‘‘(C) the reasons why persons who sought accred-
itation, but were denied accreditation, were denied; 
‘‘(D) the number of audits conducted by the Sec-
retary of accredited persons, the quality of inspections 
conducted by accredited persons, whether accredited 
persons are meeting their obligations under this Act, 
and whether the number of audits conducted is suffi-
cient to permit these assessments; 
‘‘(E) whether this subsection is achieving the goal 
of ensuring more information about establishment 
compliance is being presented to the Secretary, and 
whether that information is of a quality consistent 
with information obtained by the Secretary pursuant 
to subsection (h) or (i) of section 510; 
‘‘(F) whether this subsection is advancing efforts 
to allow device establishments to rely upon third-
party inspections for purposes of compliance with the 
laws of foreign governments; and 
‘‘(G) whether the Congress should continue, mod-
ify, or terminate the program under this subsection. 
‘‘(13) The Secretary shall include in the annual report 
required under section 903(g) the names of all accredited
persons and the particular activities under this subsection 
for which each such person is accredited and the name of 
each accredited person whose accreditation has been with-
drawn during the year.’’. 
(b) MAINTENANCE OF RECORDS.—Section 704(f) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(f)) 
is amended—
(1) in paragraph (1), in the first sentence, by 
striking ‘‘A person accredited’’ and all that follows 
through ‘‘shall maintain records’’ and inserting the
following: ‘‘An accredited person described in para-
graph (3) shall maintain records’’; 
(2) in paragraph (2), by striking ‘‘a person ac-
credited under section 523’’ and inserting ‘‘an accred-
ited person described in paragraph (3)’’; and 
(3) by adding at the end the following para-
graph: 
‘‘(3) For purposes of paragraphs (1) and (2), an ac-
credited person described in this paragraph is a person 
who—
‘‘(A) is accredited under subsection (g); or 
‘‘(B) is accredited under section 523.’’. 
(c) CONFORMING AMENDMENT.—Section 510(h) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(h)) 
is amended by inserting after ‘‘duly designated by the Sec-
retary’’ the following: ‘‘, or by persons accredited to conduct 
inspections under section 704(g),’’. 
SEC. 202. THIRD PARTY REVIEW OF PREMARKET NOTIFICA-
TION. 
Section 523 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360m) is amended—
(1) in subsection (c), by striking ‘‘The authority’’ 
and all that follows and inserting the following: ‘‘The 
authority provided by this section terminates October 
1, 2007.’’; and 
(2) by adding at the end the following subsection: 
‘‘(d) REPORT.—Not later than January 10, 2007, the 
Secretary shall conduct a study based on the experience 
under the program under this section and submit to the 
Committee on Energy and Commerce of the House of Rep-
resentatives, and the Committee on Health, Education, 
Labor, and Pensions of the Senate, a report describing the 
findings of the study. The objectives of the study shall in-
clude determining—
‘‘(1) the number of devices reviewed under this 
section; 
‘‘(2) the number of devices reviewed under this 
section that were ultimately cleared by the Secretary;
‘‘(3) the number of devices reviewed under this 
section that were ultimately not cleared by the Sec-
retary; 
‘‘(4) the average time period for a review under 
this section (including the time it takes for the Sec-
retary to review a recommendation of an accredited 
person under subsection (a) and determine the initial 
device classification); 
‘‘(5) the average time period identified in para-
graph (4) compared to the average time period for re-
view of devices solely by the Secretary pursuant to 
section 510(k); 
‘‘(6) if there is a difference in the average time 
period under paragraph (4) and the average time pe-
riod under paragraph (5), the reasons for such dif-
ference; 
‘‘(7) whether the quality of reviews under this 
section for devices for which no guidance has been 
issued is qualitatively inferior to reviews by the Sec-
retary for devices for which no guidance has been 
issued; 
‘‘(8) whether the quality of reviews under this 
section of devices for which no guidance has been 
issued is qualitatively inferior to reviews under this 
section of devices for which guidance has been issued;
‘‘(9) whether this section has in any way jeop-
ardized or improved the public health; 
‘‘(10) any impact of this section on resources 
available to the Secretary to review reports under sec-
tion 510(k); and 
‘‘(11) any suggestions for continuation, modi-
fication (including expansion of device eligibility), or 
termination of this section that the Secretary deter-
mines to be appropriate.’’. 
SEC. 203. DESIGNATION AND REGULATION OF COMBINA-
TION PRODUCTS. 
Section 503(g) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 353(g)) is amended—
(1) in paragraph (1)—
(A) in the first sentence, by striking ‘‘shall 
designate a component of the Food and Drug Ad-
ministration’’ and inserting ‘‘shall in accordance 
with this subsection assign an agency center’’; 
and 
(B) in each of subparagraphs (A) through 
(C), by striking ‘‘the persons charged’’ and in-
serting ‘‘the agency center charged’’; 
(2) by redesignating paragraph (4) as para-
graph (5);
(3) by inserting after paragraph (3) the fol-
lowing paragraph: 
‘‘(4)(A) Not later than 60 days after the date of the 
enactment of this paragraph, the Secretary shall establish 
within the Office of the Commissioner of Food and Drugs 
an office to ensure the prompt assignment of combination 
products to agency centers, the timely premarket review of 
such products, and consistent and appropriate postmarket 
regulation of like products subject to the same statutory re-
quirements to the extent permitted by law. Additionally, the 
office shall, in determining whether a product is to be des-
ignated a combination product, consult with the component 
within the Office of the Commissioner of Food and Drugs 
that is responsible for such determinations. Such office (re-
ferred to in this paragraph as the ‘Office’) shall have appro-
priate scientific and medical expertise, and shall be headed 
by a director. 
‘‘(B) In carrying out this subsection, the Office shall, 
for each combination product, promptly assign an agency 
center with primary jurisdiction in accordance with para-
graph (1) for the premarket review of such product. 
‘‘(C) In carrying out this subsection, the Office shall 
ensure timely and effective premarket reviews by overseeing 
and coordinating reviews involving more than one agency 
center.
‘‘(D) In carrying out this subsection, the Office shall 
ensure the consistency and appropriateness of postmarket 
regulation of like products subject to the same statutory re-
quirements to the extent permitted by law. Nothing in this 
paragraph shall be construed to limit the postmarket regu-
latory authority of any agency center. 
‘‘(E) In order to ensure the timeliness of the premarket 
review of a combination product, the agency center with 
primary jurisdiction for the product, and the consulting 
agency center, shall be responsible to the Office with respect 
to the timeliness of the premarket review.
‘‘(F)(i) Any dispute regarding the timeliness of the 
premarket review of a combination product may be pre-
sented to the Office for resolution, unless the timeliness of 
the dispute is clearly premature. 
‘‘(ii) During the review process, any dispute regarding 
the substance of the premarket review may be presented to 
the Commissioner of Food and Drugs after first being con-
sidered by the agency center with primary jurisdiction of 
the premarket review, under the scientific dispute resolution 
procedures for such center. The Commissioner of Food and 
Drugs shall consult with the Director of the Office in resolv-
ing the substantive dispute. 
‘‘(G) The Secretary, acting through the Office, shall re-
view each agreement, guidance, or practice of the Secretary
that is specific to the assignment of combination products 
to agency centers and shall determine whether the agree-
ment, guidance, or practice is consistent with the require-
ments of this subsection. In carrying out such review, the 
Secretary shall consult with stakeholders and the directors 
of the agency centers. After such consultation, the Secretary 
shall determine whether to continue in effect, modify, revise, 
or eliminate such agreement, guidance, or practice, and 
shall publish in the Federal Register a notice of the avail-
ability of such modified or revised agreement, guidance or 
practice. Nothing in this paragraph shall be construed as 
preventing the Secretary from following each agreement, 
guidance, or practice until continued, modified, revised, or 
eliminated. 
‘‘(H) Not later than one year after the date of the en-
actment of this paragraph and annually thereafter, the Sec-
retary shall report to the appropriate committees of Con-
gress on the activities and impact of the Office. The report 
shall include provisions—
‘‘(i) describing the numbers and types of com-
bination products under review and the timeliness in 
days of such assignments, reviews, and dispute resolu-
tions;
‘‘(ii) identifying the number of premarket re-
views of such products that involved a consulting 
agency center; and 
‘‘(iii) describing improvements in the consistency 
of postmarket regulation of combination products.’’; 
and 
(4) in paragraph (5) (as redesignated by para-
graph (2) of this section)—
(A) by redesignating subparagraphs (A) 
and (B) as subparagraphs (B) and (C), respec-
tively; and 
(B) by inserting before subparagraph (B) 
the following subparagraph: 
‘‘(A) The term ‘agency center’ means a center or 
alternative organizational component of the Food and 
Drug Administration.’’. 
SEC. 204. REPORT ON CERTAIN DEVICES. 
Not later than one year after the date of enactment 
of this Act, the Secretary of Health and Human Services 
shall report to the appropriate committees of Congress on 
the timeliness and effectiveness of device premarket reviews 
by centers other than the Center for Devices and Radio-
logical Health. Such report shall include information on the 
times required to log in and review original submissions 
and supplements, times required to review manufacturers’
replies to submissions, and times to approve or clear such 
devices. Such report shall contain the Secretary’s rec-
ommendations on any measures needed to improve perform-
ance including, but not limited to, the allocation of addi-
tional resources. Such report also shall include the Sec-
retary’s specific recommendation on whether responsibility 
for regulating such devices should be reassigned to those per-
sons within the Food and Drug Administration who are 
primarily charged with regulating other types of devices, 
and whether such a transfer could have a deleterious impact 
on the public health and on the safety of such devices. 
SEC. 205. ELECTRONIC LABELING. 
Section 502(f) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 352(f)) is amended by adding at the 
end the following: ‘‘Required labeling for prescription de-
vices intended for use in health care facilities may be made 
available solely by electronic means provided that the label-
ing complies with all applicable requirements of law and, 
that the manufacturer affords health care facilities the op-
portunity to request the labeling in paper form, and after 
such request, promptly provides the health care facility the 
requested information without additional cost.’’.
SEC. 206. ELECTRONIC REGISTRATION. 
Section 510 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360) is amended by adding at the end the 
following: 
‘‘(p) Registrations under subsections (b), (c), (d), and 
(i) (including the submission of updated information) shall 
be submitted to the Secretary by electronic means, upon a 
finding by the Secretary that the electronic receipt of such 
registrations is feasible, unless the Secretary grants a re-
quest for waiver of such requirement because use of elec-
tronic means is not reasonable for the person requesting 
such waiver.’’. 
SEC. 207. INTENDED USE. 
Section 513(i)(1)(E) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360c(i)(1)(E)) is amended by 
striking clause (iv). 
SEC. 208. MODULAR REVIEW. 
Section 515(c) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360e(c)) is amended by adding at the 
end the following: 
‘‘(3)(A) Prior to the submission of an application 
under this subsection, the Secretary shall accept and review 
portions of such applications that applicants and the Sec-
retary agree are complete, ready, and appropriate for re-
view.
‘‘(B) Each portion of a submission reviewed under sub-
paragraph (A) and found acceptable by the Secretary shall 
not be further reviewed after receipt of an application that 
satisfies the requirements of paragraph (1), unless issues of 
safety or effectiveness provide the Secretary cause to review 
such accepted portion. 
‘‘(C) Whenever the Secretary determines that a portion 
of a submission under subparagraph (A) is unacceptable, 
the Secretary shall specifically identify, in writing, the defi-
ciency of such portion and describe in detail the means by 
which it may be made acceptable, unless the sponsor is no 
longer pursuing the application.’’.
SEC. 209. PEDIATRIC EXPERTISE REGARDING CLASSIFICA-
TION-PANEL REVIEW OF PREMARKET APPLI-
CATIONS. 
Section 515(c)(2) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360e(c)(2)) is amended by adding at 
the end the following: ‘‘If the Secretary determines that 
there is a reasonable likelihood that the device involved will 
be used in a pediatric population, the Secretary shall ensure 
that such panel includes, or consults with, one or more pedi-
atric experts.’’.
SEC. 210. INTERNET LIST OF CLASS II DEVICES EXEMPTED 
FROM REQUIREMENT OF PREMARKET NOTIFI-
CATION. 
Section 510(m)(1) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360(m)(1)) is amended by adding at 
the end the following: ‘‘The Secretary shall publish such list 
on the Internet site of the Food and Drug Administration. 
The list so published shall be updated not later than 30 
days after each revision of the list by the Secretary.’’. 
SEC. 
211. 
STUDY 
BY 
INSTITUTE 
OF 
MEDICINE 
OF 
POSTMARKET 
SURVEILLANCE 
REGARDING 
PEDIATRIC POPULATIONS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall request the Institute of Medicine to enter into 
an agreement with the Secretary under which such Institute 
conducts a study for the purpose of determining whether 
the system under the Federal Food, Drug, and Cosmetic Act 
for the postmarket surveillance of medical devices provides 
adequate safeguards regarding the use of devices in pedi-
atric populations. 
(b) CERTAIN MATTERS.—The Secretary shall ensure 
that determinations made in the study under subsection (a) 
include determinations of—
(1) whether postmarket surveillance studies of 
implanted medical devices are of long enough dura-
tion to evaluate the impact of growth and develop-
ment for the number of years that the child will have 
the implant, and whether the studies are adequate to 
evaluate how children’s active lifestyles may affect the 
failure rate and longevity of the implant; and 
(2) whether the amount of funds allocated for 
postmarket surveillance by the Food and Drug Ad-
ministration of medical devices used in pediatric pop-
ulations is sufficient to provide adequate safeguards 
for such populations, taking into account the Sec-
retary’s monitoring of commitments made at the time 
of approval of medical devices, such as phase IV 
trials, and the Secretary’s monitoring and use of ad-
verse reaction reports, registries, and other postmarket 
surveillance activities. 
(c) REPORT TO CONGRESS.—The Secretary shall en-
sure that, not later than four years after the date of the 
enactment of this Act, a report describing the findings of 
the study under subsection (a) is submitted to the Congress. 
The report shall include any recommendations of the Sec-
retary for administrative or legislative changes to the sys-
tem of postmarket surveillance referred to in such sub-
section.
SEC. 212. GUIDANCE REGARDING PEDIATRIC DEVICES. 
Section 520 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360j) is amended by adding at the end the 
following subsection: 
‘‘Guidance Regarding Pediatric Devices 
‘‘(n) Not later than 270 days after the date of the en-
actment of the Medical Device User Fee and Modernization 
Act of 2002, the Secretary shall issue guidance on the fol-
lowing: 
‘‘(1) The type of information necessary to pro-
vide reasonable assurance of the safety and effective-
ness of devices intended for use in pediatric popu-
lations. 
‘‘(2) Protections for pediatric subjects in clinical 
investigations of the safety or effectiveness of such de-
vices.’’. 
SEC. 213. BREAST IMPLANTS; STUDY BY COMPTROLLER 
GENERAL. 
(a) IN GENERAL.—The Comptroller General of the 
United States shall conduct a study to determine the fol-
lowing with respect to breast implants: 
(1) The content of information typically pro-
vided by health professionals to women who consult 
with such professionals on the issue of whether to un-
dergo breast implant surgery.
(2) Whether such information is provided by 
physicians or other health professionals, and whether 
the information is provided verbally or in writing. 
(3) Whether the information provided presents a 
fair and balanced statement of the risks and benefits 
of receiving the implants (taking into account the fre-
quency of updates to the information), and if so, at 
what point in the process of determining whether to 
undergo surgery is such information provided. 
(4) Whether women understand the information 
that is provided (including full appreciation of the 
risks), and whether and to what extent the informa-
tion influences the decision to receive the implants. 
(5) The number of adverse events that have been 
reported, and whether such events have been ade-
quately investigated. 
(6) With respect to women who participate as 
subjects in research being carried out regarding the 
safety and effectiveness of breast implants: 
(A) The content of information provided to 
the women during the process of obtaining the 
informed consent of the women to be subjects, 
and whether such information is appropriately 
updated.
(B) Whether such process provides written 
explanations of the criteria for being subjects in 
the research. 
(C) The point at which, in the planning or 
conduct of the research, the women are provided 
information regarding the provision of informed 
consent to be subjects. 
(D) Whether, before providing informed con-
sent, the women fully appreciate the risks of 
being subjects in the research. 
(b) REPORT.—The Comptroller General shall submit 
to the Congress a report describing the findings of the study. 
(c) DEFINITION.—For purposes of this section, the 
term ‘‘breast implant’’ means a breast prosthesis that is im-
planted to augment or reconstruct the female breast.
SEC. 214. BREAST IMPLANTS; RESEARCH THROUGH NA-
TIONAL INSTITUTES OF HEALTH. 
(a) REPORT ON STATUS OF CURRENT RESEARCH.—
Not later than 180 days after the date of the enactment of 
this Act, the Director of the National Institutes of Health 
shall submit to the Congress a report describing the status 
of research on breast implants (as defined in section 213(c)) 
being conducted or supported by such Institutes. 
(b) RESEARCH ON LONG-TERM IMPLICATIONS.—Part 
H of title IV of the Public Health Service Act (42 U.S.C.
289 et seq.) is amended by adding at the end of the following 
section: 
‘‘SEC. 498C. BREAST IMPLANT RESEARCH. 
‘‘(a) IN GENERAL.—The Director of NIH shall conduct 
or support prospective or retrospective research to examine 
the long-term health implications of both saline and silicone 
breast implants. If scientifically appropriate, such research 
studies may include the following: 
‘‘(1) A multidisciplinary study of women who 
have received silicone and saline implants and have 
had an implant for a sufficient amount of time to 
allow for appropriate comparison as to the long-term 
health consequences. 
‘‘(2) A comparison of women receiving implants 
for reconstruction after mastectomy to breast cancer 
patients who have not had reconstruction, including 
subsets of women with saline implants and women 
with silicone implants. 
‘‘(b) DEFINITION.—For purposes of this section, the 
term ‘breast implant’ means a breast prosthesis that is im-
planted to augment or reconstruct the female breast.’’.
TITLE III—ADDITIONAL 
AMENDMENTS 
SEC. 301. IDENTIFICATION OF MANUFACTURER OF MED-
ICAL DEVICES. 
(a) IN GENERAL.—Section 502 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 352) is amended by 
adding at the end the following: 
‘‘(u) If it is a device, unless it, or an attachment there-
to, prominently and conspicuously bears the name of the 
manufacturer of the device, a generally recognized abbrevia-
tion of such name, or a unique and generally recognized 
symbol identifying such manufacturer, except that the Sec-
retary may waive any requirement under this paragraph 
for the device if the Secretary determines that compliance 
with the requirement is not feasible for the device or would 
compromise the provision of reasonable assurance of the 
safety or effectiveness of the device.’’. 
(b) EFFECTIVE DATE.—The amendment made by sub-
section (a) takes effect 18 months after the date of the enact-
ment of this Act, and only applies to devices introduced 
or delivered for introduction into interstate commerce after 
such effective date. 
SEC. 302. SINGLE-USE MEDICAL DEVICES. 
(a) REQUIRED STATEMENTS ON LABELING.—
(1) IN GENERAL.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act, as amended by section 
301 of this Act, is amended by adding at the end the 
following: 
‘‘(v) If it is a reprocessed single-use device, unless all 
labeling of the device prominently and conspicuously bears 
the statement ‘Reprocessed device for single use. Reprocessed 
by ll.’ The name of the manufacturer of the reprocessed 
device shall be placed in the space identifying the person 
responsible for reprocessing.’’. 
(2) EFFECTIVE DATE.—The amendment made by 
paragraph (1) takes effect 15 months after the date of 
the enactment of this Act, and only applies to devices 
introduced or delivered for introduction into inter-
state commerce after such effective date. 
(b) PREMARKET NOTIFICATION.—Section 510 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is 
amended by inserting after subsection (n) the following: 
‘‘(o)(1) With respect to reprocessed single-use devices 
for which reports are required under subsection (k): 
‘‘(A) The Secretary shall identify such devices or 
types of devices for which reports under such sub-
section must, in order to ensure that the device is sub-
stantially equivalent to a predicate device, include 
validation data, the types of which shall be specified
by the Secretary, regarding cleaning and sterilization, 
and functional performance demonstrating that the 
single-use device will remain substantially equivalent 
to its predicate device after the maximum number of 
times the device is reprocessed as intended by the per-
son submitting the premarket notification. Within one 
year after enactment of this subsection, the Secretary 
shall publish in the Federal Register a list of the 
types so identified, and shall revise the list as appro-
priate. Reports under subsection (k) for devices or 
types of devices within a type included on the list are, 
upon publication of the list, required to include such 
validation data. 
‘‘(B) In the case of each report under subsection 
(k) that was submitted to the Secretary before the 
publication of the initial list under subparagraph 
(A), or any revision thereof, and was for a device or 
type of device included on such list, the person who 
submitted the report under subsection (k) shall submit 
validation data as described in subparagraph (A) to 
the Secretary not later than nine months after the 
publication of the list. During such nine-month pe-
riod, the Secretary may not take any action under 
this Act against such device solely on the basis that 
the validation data for the device have not been sub-
mitted to the Secretary. After the submission of the 
validation data to the Secretary, the Secretary may 
not determine that the device is misbranded under 
section 502(o), adulterated under section 501(f)(1)(B), 
or take action against the device under section 301(p) 
for failure to provide any information required by 
subsection (k) until (i) the review is terminated by 
withdrawal of the submission of the report under sub-
section (k); (ii) the Secretary finds the data to be ac-
ceptable and issues a letter; or (iii) the Secretary de-
termines that the device is not substantially equiva-
lent to a predicate device. Upon a determination that 
a device is not substantially equivalent to a predicate 
device, or if such submission is withdrawn, the device 
can no longer be legally marketed. 
‘‘(C) In the case of a report under subsection (k) 
for a device identified under subparagraph (A) that 
is of a type for which the Secretary has not pre-
viously received a report under such subsection, the 
Secretary may, in advance of revising the list under 
subparagraph (A) to include such type, require that 
the report include the validation data specified in 
subparagraph (A).
‘‘(D) Section 502(o) applies with respect to the 
failure of a report under subsection (k) to include val-
idation data required under subparagraph (A). 
‘‘(2) With respect to critical or semicritical reprocessed 
single-use devices that, under subsection (l) or (m), are ex-
empt from the requirement of submitting reports under sub-
section (k): 
‘‘(A) The Secretary shall identify such devices or 
types of devices for which such exemptions should be 
terminated in order to provide a reasonable assurance 
of the safety and effectiveness of the devices. The Sec-
retary shall publish in the Federal Register a list of 
the devices or types of devices so identified, and shall 
revise the list as appropriate. The exemption for each 
device or type included on the list is terminated upon 
the publication of the list. For each report under sub-
section (k) submitted pursuant to this subparagraph 
the Secretary shall require the validation data de-
scribed in paragraph (1)(A). 
‘‘(B) For each device or type of device included 
on the list under subparagraph (A), a report under 
subsection (k) shall be submitted to the Secretary not
later than 15 months after the publication of the initial 
list, or a revision of the list, whichever terminates the ex-
emption for the device. During such 15-month period, the
Secretary may not take any action under this Act against 
such device solely on the basis that such report has not been 
submitted to the Secretary. After the submission of the re-
port to the Secretary the Secretary may not determine that 
the device is misbranded under section 502(o), adulterated 
under section 501(f)(1)(B), or take action against the device 
under section 301(p) for failure to provide any information 
required by subsection (k) until (i) the review is terminated 
by withdrawal of the submission; (ii) the Secretary deter-
mines by order that the device is substantially equivalent 
to a predicate device; or (iii) the Secretary determines by 
order that the device is not substantially equivalent to a 
predicate device. Upon a determination that a device is not 
substantially equivalent to a predicate device, the device can 
no longer be legally marketed. 
‘‘(C) The initial list under subparagraph (A) 
shall be published not later than 18 months after the 
effective date of this subsection. 
‘‘(D) Section 502(o) applies with respect to the 
failure to submit a report under subsection (k) that 
is required pursuant to subparagraph (A), including 
a failure of the report to include validation data re-
quired in such subparagraph. 
‘‘(E) The termination under subparagraph (A) 
of an exemption under subsection (l) or (m) for a
critical or semicritical reprocessed single-use device 
does not terminate the exemption under subsection (l) 
or (m) for the original device. 
‘‘(3) In the case of a reprocessed single-use device that 
is classified in class III and for which a premarket applica-
tion is required, the following provisions apply with respect 
to such reprocessed device in lieu of an application for pre-
market approval under section 515: 
‘‘(A) The device shall not be introduced into 
interstate commerce or delivered for introduction into 
interstate commerce unless the person involved has 
submitted to the Secretary a report in accordance 
with this paragraph and the Secretary, after review-
ing the report, issues an order determining there is a 
reasonable assurance of the safety and effectiveness for 
the device. 
‘‘(B) The report under subparagraph (A) shall 
contain the following: 
‘‘(i) The device name, including both the 
trade or proprietary name and the common or 
usual name. 
‘‘(ii) The establishment registration number 
of the owner or operator submitting the report. 
‘‘(iii) Actions taken to comply with per-
formance standards under section 514.
‘‘(iv) Proposed labels, labeling, and adver-
tising sufficient to describe the device, its in-
tended use, and directions for use. 
‘‘(v) Full reports of all information, pub-
lished or known to or which should be reasonably 
known to the applicant, concerning investiga-
tions which have been made to show whether or 
not a device is safe or effective. 
‘‘(vi) A description of the device’s compo-
nents, ingredients, and properties. 
‘‘(vii) A full description of the methods used 
in, and the facilities and controls used for, the 
reprocessing and packing of the device. 
‘‘(viii) Such samples of the device that the 
Secretary may reasonably require. 
‘‘(ix) A financial certification or disclosure 
statement or both, as required by part 54 of title 
21, Code of Federal Regulations. 
‘‘(x) A statement that the applicant believes 
to the best of the applicant’s knowledge that all 
data and information submitted to the Secretary 
are truthful and accurate and that no material 
fact has been omitted in the report. 
‘‘(xi) Any additional data and information 
that the Secretary determines is necessary to de-
termine whether there is reasonable assurance of 
safety and effectiveness for the reprocessed device. 
‘‘(C) In addition to the information or data re-
quired in subparagraph (B), the report under sub-
paragraph (A) shall include the validation data de-
scribed in paragraph (1)(A) that demonstrates that 
the reasonable assurance of the safety or effectiveness 
of the device will remain after the maximum number 
of times the device is reprocessed as intended by the 
person submitting the report under this paragraph.’’. 
(c) DEFINITIONS.—Section 201 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321) is amended by 
adding at the end the following: 
‘‘(ll)(1) The term ‘single-use device’ means a device 
that is intended for one use, or on a single patient during 
a single procedure. 
‘‘(2)(A) The term ‘reprocessed’, with respect to a single-
use device, means an original device that has previously 
been used on a patient and has been subjected to additional 
processing and manufacturing for the purpose of an addi-
tional single use on a patient. The subsequent processing 
and manufacture of a reprocessed single-use device shall re-
sult in a device that is reprocessed within the meaning of 
this definition.
‘‘(B) A single-use device that meets the definition 
under subparagraph (A) shall be considered a reprocessed 
device without regard to any description of the device used 
by the manufacturer of the device or other persons, includ-
ing a description that uses the term ‘recycled’ rather than 
the term ‘reprocessed’. 
‘‘(3) The term ‘original device’ means a new, unused 
single-use device. 
‘‘(mm)(1) The term ‘critical reprocessed single-use de-
vice’ means a reprocessed single-use device that is intended 
to contact normally sterile tissue or body spaces during use. 
‘‘(2) The term ‘semi-critical reprocessed single-use de-
vice’ means a reprocessed single-use device that is intended 
to contact intact mucous membranes and not penetrate nor-
mally sterile areas of the body.’’. 
(d) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended 
by section 321(b)(2) of Public Law 107–188, is amended 
by adding at the end the following: 
‘‘(gg) The introduction or delivery for introduction 
into interstate commerce of any device in violation of sec-
tion 510(o)(3).’’.
Union Calendar No. 455
107TH CONGRESS 
2D SESSION 
H. R. 3580
[Report No. 107–728] 
A BILL 
To amend the Federal Food, Drug, and Cosmetic 
Act to make improvements in the regulation of 
medical devices, and for other purposes. 
OCTOBER 7, 2002
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union, 
and ordered to be printed