Medical Device User Fee and Modernization Act of 2002
PL 107-250 (H.R.5651), enacted 10/26/2002

116 STAT. 1588 
PUBLIC LAW 107-250—OCT. 26, 2002 
Public Law 107-250 
107th Congress 
Oct. 26, 2002 
[H.R. 5651] 
Medical Device 
User Fee and 
Modernization 
Act of 2002. 
21 u s e 301 note. 
An Act 
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 Representatives 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. Debarment of accredited persons. 
Sec. 204. Designation and regulation of combination products. 
Sec. 205. Report on certain devices. 
Sec. 206. Electronic labeling. 
Sec. 207. Electronic registration. 
Sec. 208. Intended use. 
Sec. 209. Modular review. 
Sec. 210. Pediatric expertise regarding classification-panel review of premarket ap-
plications. 
Sec. 211. Internet list of class II devices exempted from requirement of premarket 
notification. 
Sec. 212. Study by Institute of Medicine of postmarket siuveillance regarding pedi-
atric populations. 
Sec. 213. Guidance regarding pediatric devices. 
Sec. 214. Breast implants; study by Comptroller General. 
Sec. 215. 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. 
Sec. 303. MedWatch. 
PUBLIC LAW 107-250—OCT. 26, 2002 
116 STAT. 1589 
TITLE I~FEES RELATED TO MEDICAL 
DEVICES 
SEC. 101. FINDINGS. 
21 USC 379i 
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 making additional 
funds available for the purpose of augmenting the resources 
of the Food and Drug Administration that are devoted to the 
process for the review of devices and the assurance of device 
safety and effectiveness so that statutorily mandated deadlines 
may be met; and 
(3) the fees authorized by this title 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 Com-
mittee on Health, Education, Labor, and Pensions of the Senate, 
as set forth in the Congressional Record. 
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. 
21 USC 379i. 
"For purposes of this subchapter: 
"(1) The term 'premarket application' means— 
"(A) an application for approval of a device submitted 
under section 515(c) or section 351 of the Public Health 
Service Act; or 
"(B) a product development protocol described in sec-
tion 515(f). 
Such term does not include a supplement, a premarket report, 
or a premarket notification submission. 
"(2) The term 'premarket report' means a report submitted 
under section 515(c)(2). 
"(3) The term 'premarket notification submission' 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 supple-
ment, or an efficacy supplement, means a request to the Sec-
retary to approve a change in a device for which— 
"(i) an application or report has been approved under 
section 515(d), or an application has been approved under 
section 351 of the Public Health Service Act; or 
"(ii) a notice of completion has become effective under 
section 515(f). 
"(B) The term 'panel-track supplement' means a supple-
ment to an approved premarket application or premarket report 
under section 515 that requests a significant change in design 
or performance of the device, or a new indication for use of 
116 STAT. 1590 
PUBLIC LAW 107-250—OCT. 26, 2002 
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 or premarket report 
under section 515 that is not a panel-track supplement and 
requests a significant change in components, materials, design, 
specification, software, color additives, or labeling. 
"(D) The term 'real-time supplement' means a supplement 
to an approved premarket application or premarket report 
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 labeling, 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 supplement. 
"(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 applications, premarket reports, 
supplements, and premarket notification submissions: 
"(A) The activities necessary for the review of pre-
market applications, premarket reports, supplements, and 
premarket notification submissions. 
"(B) The issuance of action letters that allow the mar-
keting of devices or which set forth in detail the specific 
deficiencies in such applications, reports, supplements, or 
submissions and, where appropriate, the actions necessary 
to place them in condition for approval. 
"(C) The inspection of manufacturing establishments 
and other facilities undertaken as part of the Secretary's 
review of pending premarket applications, premarket 
reports, and supplements. 
"(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 inves-
tigational device 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, premarket reports, supplements, 
and premarket notification submissions. 
"(G) The development of voluntary test methods, con-
sensus standards, or mandatory performance standards 
under section 514 in connection with the review of such 
applications, reports, supplements, or submissions and 
related activities. 
"(H) The provision of technical assistance to device 
manufacturers in connection with the submission of such 
applications, reports, supplements, or submissions. 
PUBLIC LAW 107-250—OCT. 26, 2002 
116 STAT. 1591 
"(I) Any activity undertaken under section 513 or 515(i) 
in connection with the initial classification or reclassifica-
tion of a device or under section 515(b) in connection with 
any requirement for approval of a device. 
"(J) Evaluation of postmarket studies required as a 
condition of an approval of a premarket 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 premarket applications, pre-
market reports, supplements, 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 Adminis-
tration, advisory committees, and costs related to such 
officers, employees, and committees and to contracts with 
such contractors; 
"(B) management of information, and the acquisition, 
maintenance, and repair of computer resources; 
"(C) leasing, maintenance, renovation, and repair of 
facilities and acquisition, maintenance, and repair of fix-
tures, furniture, scientific equipment, and other necessary 
materials and supplies; and 
"(D) collecting fees and accounting for resources allo-
cated for the review of premarket applications, 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. 
21USC 379j. 
"(a) TYPES OF FEES.—Beginning on the date of the enactment 
of the Medical Device User Fee and Modernization Act of 2002, 
the Secretary shall assess and collect fees in accordance with this 
section as follows: 
"(1) PREMARKET APPLICATION, PREMARKET REPORT, SUPPLE-
MENT, AND SUBMISSION FEE.— 
"(A) IN GENERAL.—^Except as provided in subparagraph 
(B) and subsection (d), each person who submits any of 
the following, on or after October 1, 2002, shall be subject 
to a fee established under subsection (c)(5) for the fiscal 
year involved in accordance with the following: 
"(i) A premarket application. 
116 STAT. 1592 
PUBLIC LAW 107-250—OCT. 26, 2002 
"(ii) For a premarket report, a fee equal to the 
fee that appHes 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 1.42 percent of the fee that applies under 
clause (i), subject to any adjustment under subsection 
(c)(3) and any adjustment under subsection (e)(2)(C)(ii). 
"(B) EXCEPTIONS.— 
"(i) 
HUMANITARIAN 
DEVICE 
EXEMPTION.—^An 
application under section 520(m) is not subject to any 
fee under subparagraph (A). 
"(ii) FURTHER MANUFACTURING USE.—No fee shall 
be required under subparagraph (A) for the submission 
of a premarket application under section 351 of the 
Public Health Service Act for a product licensed for 
further manufacturing use only. 
"(iii) STATE OR FEDERAL GOVERNMENT SPONSORS.— 
No fee shall be required under subparagraph (A) for 
a premarket application, premarket report, supple-
ment, or premarket notification submission submitted 
by a State or Federal Government entity unless the 
device involved is to be distributed commercially. 
"(iv) 
PREMARKET NOTIFICATIONS BY THIRD PAR-
TIES.—No fee shall be required under subparagraph 
(A) for a premarket notification submission reviewed 
by an accredited person pursuant to section 523. 
"(v) PEDIATRIC CONDITIONS OF USE.— 
"(I) IN GENERAL.—No fee shall be required 
under subparagraph (A) for a premarket applica-
tion, premarket report, or premarket notification 
submission if the proposed conditions of use for 
the device involved are solely for a pediatric popu-
lation. 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 pediatric population. 
"(II) SUBSEQUENT PROPOSAL OF ADULT CONDI-
TIONS OF USE.—In the case of a person who sub-
mits a premarket application or premarket report 
for which, under subclause (I), a fee under 
subparagraph (A) is not required, any supplement 
to such application that proposes conditions of use 
for any adult population is subject to the fee that 
applies under such subparagraph for a premarket 
application. 
"(C) PAYMENT.—The fee required by subparagraph (A) 
shall be due upon submission of the premarket application, 
premarket report, supplement, or premarket notification 
submission except that invoices for applications submitted 
PUBLIC LAW 107-250—OCT. 26, 2002 
116 STAT. 1593 
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 portions 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 FILING.—The Sec-
retary shall refund 75 percent of the fee paid under 
subparagraph (A) for any application or supplement 
that is refused for filing. 
"(ii) APPLICATION WITHDRAWN BEFORE FILING.—^The 
Secretary shall refund 75 percent of the fee paid under 
subparagraph (A) for any application or supplement 
that is withdrawn prior to the filing decision of the 
Secretary. 
"(iii) 
APPLICATION 
WITHDRAWN 
BEFORE 
FIRST 
ACTION.—^After receipt of a request for a refund of 
the fee paid under subparagraph (A) for a premarket 
application, premarket report, or supplement that is 
withdrawn after filing but before a first action, 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 portion 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 sub-
sections (c), (d), (e), (g), and (h), 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 enactment of the Medical Device User Fee and 
Modernization Act of 2002 requiring the Secretary to fund addi-
tional costs of the retirement of Federal personnel, fee revenue 
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 established in Federal Register, 
subsection (b) shall be adjusted by the Secretary by notice, publication, 
published in the Federal Register, for a fiscal year to reflect 
the greater of— 
"(A) the total percentage change that occurred in the 
Consumer Price Index for all urban consumers (all items; 
U.S. city average) for the 12 month period ending June 
30 preceding the fiscal year for which fees are being estab-
lished, or 
"(B) the total percentage change for the previous fiscal 
year in basic pay under the General Schedule in accordance 
with section 5332 of title 5, United States Code, as adjusted 
116 STAT. 1594 
PUBLIC LAW 107-250—OCT. 26, 2002 
Federal Register, 
publication. 
Federal Register, 
publication. 
by any locality-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 subsection shall 
be added on a compounded basis to the sum of all adjustments 
made each fiscal year after fiscal year 2003 under this sub-
section. 
"(2) WORKLOAD ADJUSTMENT.—^After the fee revenues estab-
lished in subsection (b) are adjusted for a fiscal year for inflation 
in accordance with paragraph (1), the fee revenues shall, begin-
ning with fiscal year 2004, be adjusted further each fiscal 
year to reflect changes in the workload of the Secretary for 
the process for the review of device applications. With respect 
to such adjustment: 
"(A) The adjustment shall be determined by the Sec-
retary based on a weighted average of the change in the 
total number of premarket applications, investigational 
new device applications, premarket reports, supplements, 
and premarket notification submissions submitted to the 
Secretary. The Secretary shall publish in the Federal Reg-
ister the fee revenues and fees resulting from the adjust-
ment and the supporting methodologies. 
"(B) Under no circumstances shall the adjustment 
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 paragraph (1), and for workload 
in accordance with paragraph (2), the fee revenues shall, begin-
ning with fiscal year 2004, be adjusted further each fiscal 
year, if necessary, to reflect the cumulative amount by which 
collections for previous fiscal years, beginning with fiscal year 
2003, fell below the cumulative revenue amounts for such fiscal 
years specified in subsection (b), adjusted for such fiscal years 
for inflation in accordance with paragraph (1), and for workload 
in accordance with paragraph (2). 
"(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 estab-
lished 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 
applications 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 estab-
lishing fee revenues and fees for fiscal year 2007. If the Sec-
retary has carryover user fee balances for such process in 
excess of three months of such operating reserves, the adjust-
ment 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 subsection (a), based on the revenue 
amounts established under subsection (b) and the adjustment 
provided under this subsection and subsection (e)(2)(C)(ii}, 
PUBLIC LAW 107-250—OCT. 26, 2002 
116 STAT. 1595 
except that the fees estabUshed for fiscal year 2003 shall be 
based on a premarket application fee of $154,000. 
"(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 BUSINESSES; FEE WAIVER AND FEE REDUCTION 
REGARDING PREMARKET APPROVAL FEES.— 
"(1) IN GENERAL.—The Secretary shall grant a waiver of 
the fee required under subsection (a) for one premarket applica-
tion, or one premarket report, where the Secretary finds that 
the applicant involved is a small business submitting its first 
premarket application to the Secretary, or its first premarket 
report, respectively, for review. In addition, for subsequent 
premarket applications, premarket reports, and supplements 
where the Secretary finds that the applicant 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 accord-
ance with paragraph (2)(C). 
"(2) RULES RELATING TO PREMARKET APPROVAL FEES.— 
"(A) DEFINITION.— 
"(i) IN GENERAL.—For purposes of this subsection, 
the term 'small business' means an entity that reported 
$30,000,000 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, and parent firms. 
"(ii) ADJUSTMENT.—The Secretary may adjust the 
$30,000,000 threshold established in clause (i) if the 
Secretary has evidence from actual experience that 
this threshold results in a reduction in revenues from 
premarket applications, premarket reports, and supple-
ments that is 16 percent or more than would occur 
without small business exemptions and lower fee rates. 
To adjust this threshold, the Secretary shall publish 
Federal Register, 
a notice in the Federal Register setting out the publication. 
rationale for the adjustment, and the new threshold. Notice. 
"(B) EVIDENCE OF QUALIFICATION.—An applicant shall 
pay the higher fees established by the Secretary each year 
unless the applicant submits evidence that it qualifies for 
a waiver of the fee or the lower fee rate. The applicant 
shall support 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 taxable year, and a copy 
of such returns of its affiliates, partners, and parent firms, 
which show an amount of gross sales or receipts that 
is less than the maximum established in subparagraph 
(A). The applicant, and each of such affiliates, partners, 
and parent firms, shall certify that the information pro-
vided is a true and accurate copy of the actual tax forms 
they submitted to the Internal Revenue Service. If no tax 
forms are submitted for affiliates, partners, or parent firms, 
the applicant shall certify that the applicant has no affili-
ates, partners, or parent firms, respectively. 
"(C) REDUCED FEES.—^Where the Secretary finds that 
the applicant involved meets the definition under subpara-
graph (A), the fees established under subsection (c)(5) may 
116 STAT. 1596 
PUBLIC LAW 107-250—OCT. 26, 2002 
be paid at a reduced rate of 38 percent of the fee established 
under such subsection for a premarket application, a pre-
market report, or a supplement. 
"(D) 
REQUEST FOR FEE WAIVER OR REDUCTION.—An 
applicant seeking a fee waiver or reduction under this 
subsection shall submit supporting information to the Sec-
retary at least 60 days before the fee is required pursuant 
to subsection (a). The decision of the Secretary regarding 
whether an entity qualifies for such a waiver or reduction 
is not reviewable. 
"(e) 
SMALL BUSINESSES; FEE REDUCTION REGARDING PRE-
MARKET NOTIFICATION SUBMISSIONS.— 
"(1) IN GENERAL.—^Where the Secretary finds that the 
applicant involved is a small business, the fee specified in 
subsection (a)(l)(A)(vii) may be paid at a reduced rate in accord-
ance with paragraph (2)(C). 
"(2) RULES RELATING TO PREMARKET NOTIFICATION SUBMIS-
SIONS.— 
"(A) DEFINITION.—For purposes of this subsection, the 
term 'small business' means an entity that reported 
$30,000,000 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, 
and parent firms. 
"(B) EVIDENCE OF QUALIFICATION.—^An applicant shall 
pay the higher fees established by the Secretary each year 
unless the applicant submits evidence that it qualifies for 
the lower fee rate. The applicant shall support 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 taxable year, and a copy of such returns 
of its affiliates, partners, and parent firms, which show 
an amount of gross sales or receipts that is less than 
the maximum established in subparagraph (A). The 
applicant, and each of such affiliates, partners, and parent 
firms, shall certify that the information provided is a true 
and accurate copy of the actual tax forms they submitted 
to the Internal Revenue Service. If no tax forms are sub-
mitted for affiliates, partners, or parent firms, the applicant 
shall certify that the applicant has no affiliates, partners, 
or parent firms, respectively. 
"(C) REDUCED FEES.— 
"(i) IN GENERAL.—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 80 percent of the fee that 
applies under subsection (a)(l)(A)(vii), as adjusted 
under clause (ii) and as established under subsection 
(cX5). 
"(ii) ADJUSTMENT PER FEE REVENUE AMOUNT.—^For 
fiscal year 2004 and each subsequent fiscal year, the 
Secretary, in setting the revenue amount under sub-
section (c)(5) for premarket notification submissions, 
shall determine the revenue amount that would apply 
if all such submissions for the fiscal year involved 
paid a fee equal to 1.42 percent of the amount that 
applies under subsection (a)(l)(A)(i) for premarket 
PUBLIC LAW 107-250—OCT. 26, 2002 
116 STAT. 1597 
applications, and shall adjust the fee under subsection 
(a)(l)(A)(vii) for premarket notification submissions 
such that the reduced fees collected under clause (i) 
of this subparagraph, when added to fees for such 
submissions that are not paid at the reduced rate, 
will equal such revenue amount for the fiscal year. 
"(D) REQUEST FOR REDUCTION.—^An applicant seeking 
a fee reduction under this subsection shall submit sup-
porting information to the Secretary at least 60 days before 
the fee is required pursuant to subsection (a). The decision 
of the Secretary regarding whether an entity qualifies for 
such a reduction is not reviewable. 
"(f) EFFECT OF FAILURE TO PAY FEES.—^A premarket application, 
premarket report, supplement, or premarket notification submission 
submitted by a person subject to fees under subsection (a) shall 
be considered incomplete and shall not be accepted for filing by 
the Secretary until all fees owed by such person have been paid. 
"(g) 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 Mod-
ernization Act of 2002 (referred to in this paragraph as 
'performance 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 adjustment factor applicable to the fiscal 
year. 
"(ii) For each of the fiscal years 2003 and 2004, if 
the amount so appropriated for the fiscal year involved, 
excluding the amount of fees appropriated for such fiscal 
year, is less than the amount that applies under clause 
(i) for such fiscal 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 extent the Secretary is meeting 
the performance goals identified for such fiscal year, 
and whether the Secretary will be able to meet all 
performance goals identified for fiscal 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 performance goals identified for the 
fiscal year if the total of the amounts so appropriated 
for fiscal years 2003 through 2005, excluding the amount 
Reports. 
Deadline. 
116 STAT. 1598 
PUBLIC LAW 107-250—OCT. 26, 2002 
Reports. 
Deadline. 
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 appropriated 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 extent the Secretary is meeting 
the performance goals identified for such fiscal year, 
and whether the Secretary will be able to meet all 
performance goals identified for fiscal year 2006. The 
report under the preceding 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 appro-
priated for fiscal years 2003 through 2006, excluding the 
amount of fees appropriated for such fiscal years, is less 
than the sum o
f
— 
"(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 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 Secretary may assess and collect such fees, without any 
modification in the rate for premarket applications, supple-
ments, premarket reports, and premarket notification submis-
sions, and at any time in such fiscal year, notwithstanding 
the provisions of subsection (a) relating to the date fees are 
to be paid. 
PUBLIC LAW 107-250—OCT. 26, 2002 
116 STAT. 1599 
"(h) CREDITING AND AVAILABILITY OF FEES.— 
"(1) IN GENERAL.—Fees authorized under subsection (a) 
shall be collected and available for obligation only to the extent 
and in the amount provided in advance in appropriation Acts. 
Such fees are authorized to be appropriated to remain available 
until expended. Such sums as may be necessary may be trans-
ferred from the Food and Drug Administration salaries and 
expenses appropriation account without fiscal year limitation 
to such appropriation account for salaries and expenses with 
such fiscal year limitation. The sums transferred shall be avail-
able solely for the process for the review of device applications. 
"(2) COLLECTIONS AND APPROPRIATION ACTS.— 
"(A) IN GENERAL.—The fees 
authorized 
by 
this 
section— 
"(i) shall be retained in each fiscal year in an 
amount not to exceed the amount specified in appro-
priation Acts, or otherwise made available for obliga-
tion, for such fiscal year, and 
"(ii) shall only be collected and available to defray 
increases in the costs of the resources allocated for 
the process for the review of device applications 
(including increases in such costs for an additional 
number of full-time equivalent positions in the Depart-
ment of Health and Human Services to be engaged 
in such process) over such costs, excluding costs paid 
from fees collected 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 subparagraph (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 subparagraph. 
"(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 revenues 
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 Administra-
tion as provided in paragraph (1), and shall be subtracted 
116 STAT. 1600 
PUBLIC LAW 107-250—OCT. 26, 2002 
Deadline. 
Deadline. 
21 u s e 379j 
note. 
21 u s e 379i 
note. 
Deadline. 
from the amount of fees that would otherwise be authorized 
to be collected under this section pursuant to appropriation 
Acts for a subsequent fiscal year. 
"(i) COLLECTION OF UNPAID FEES.—In any case where the Sec-
retary does not receive payment of a fee assessed 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. 
"(j) WRITTEN REQUESTS FOR REFUNDS.—To qualify for consider-
ation 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. 
"(k) CONSTRUCTION.—This section may not be construed to 
require that the number of full-time equivalent positions in the 
Department of Health and Human Services, 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 SUBMITTING PRE-
MARKET REPORTS.— 
(1) IN GENERAL.—^A person submitting a premarket report 
to the Secretary of Health and Human Services is exempt 
from the fee under section 738(a)(l)(A)(ii) of the Federal Food, 
Drug, and Cosmetic Act (as added by subsection (a) of this 
section) if— 
(A) the premarket report is the first such report sub-
mitted to the Secretary by the person; and 
(B) before October 1, 2002, the person submitted a 
premarket application to the Secretary for the same device 
as the device for which the person is submitting the pre-
market 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 Federal Food, Drug, and Cosmetic Act (as 
added by subsection (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 Commerce 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 Administration 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 Administration 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 Administra-
tion, 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 APPROPRIATIONS.—For 
the 
purpose of carrying out postmarket surveillance of medical devices. 
PUBLIC LAW 107-250—OCT. 26, 2002 
116 STAT. 1601 
there are authorized to be appropriated to the Food and Drug 
Administration the following amounts, stated as increases above 
the amount obligated 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 fiscal year, 
an increase of such sums as may be necessary. 
(b) STUDY.— 
21 use 3791 
(1) IN GENERAL.—^The Secretary of Health and Human note. 
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 amendment 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 devices. 
(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 devices. 
(D) The extent to which device companies comply with 
the 
postmarket 
surveillance 
requirements, 
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 program is extended beyond fiscal year 
2007. 
(2) REPORT.—Not later than January 10, 2007, the Sec-
retary shall submit to the Committee on Energy 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 Con-
gress 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 reauthorization 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 Com-
merce 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 pubUsh in the 
Federal Register, 
Federal Register recommendations under subsection (a), after nego- publication, 
tiations with the regulated industry; shall present such rec-
ommendations to the congressional committees specified in such 
paragraph; shall hold a meeting at which the public may present 
its views on such recommendations; and shall provide for a period 
of 30 days for the public to provide written comments on such 
recommendations. 
Deadline. 
21 use 379i 
note. 
116 STAT. 1602 
PUBLIC LAW 107-250—OCT. 26, 2002 
21 u s e 379i 
note. 
21 u s e 379i 
note. 
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 submissions 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 annual reports 
ceases to be effective January 31, 2008. 
TITLE II—AMENDMENTS REGARDING 
REGULATION OF MEDICAL DEVICES 
Deadline. 
Deadline. 
Federal Register, 
publication. 
SEC. 201. D^SPECTIONS 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 for the purpose of conducting 
inspections of establishments that manufacture, prepare, propagate, 
compound, or process class II or class III devices that are required 
in section 510(h), or inspections of such establishments required 
to register pursuant to section 510(i). The owner or operator of 
such an establishment that is eligible 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 enactment 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 adequate for review, and the Secretary shall 
promptly act on the request for accreditation. Any resulting accredi-
tation shall state that such person is accredited to conduct inspec-
tions at device establishments identified in paragraph (1), The 
accreditation of such person shall specify the particular activities 
under this subsection for which such person is accredited. In the 
first year following the publication in the Federal Register of criteria 
to accredit or deny accreditation 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 paragraph (1). 
"(3) An accredited person shall, at a minimum, meet the fol-
lowing requirements: 
"(A) Such person may not be an employee of the Federal 
Government. 
"(B) Such person shall be an independent organization 
which is not owned or controlled by a manufacturer, supplier, 
or vendor of articles regulated under this Act and which has 
no organizational, material, or financial affiliation (including 
a consultative affiliation) with such a manufacturer, supplier, 
or vendor. 
PUBLIC LAW 107-250—OCT. 26, 2002 
116 STAT. 1603 
"(C) Such person shall be a legally constituted entity per-
mitted to conduct the activities for which it seeks accreditation. 
"(D) Such person shall not engage in the design, manufac-
ture, promotion, or sale of articles regulated under this Act. 
"(E) The operations of such person shall be in accordance 
with generally accepted professional and ethical business prac-
tices, and such person shall agree in writing that at a minimum 
the person will— 
"(i) certify that reported information accurately reflects 
data reviewed, inspection observations made, other matters 
that relate to or may influence compliance with this Act, 
and recommendations made during an inspection or at 
an inspection's closing meeting; 
"(ii) limit work to that for which competence and 
capacity are available; 
"(iii) treat information received, records, reports, and 
recommendations as confidential commercial or financial 
information 
or trade secret information, except such 
information may be made available to the Secretary; 
"(iv) promptly respond and attempt to resolve com-
plaints 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 avail-
able to the public disclosures of the extent to which the 
accredited person, and the officers and employees of the 
person, have maintained compliance with requirements 
under this clause relating to financial conflicts of interest. 
"(4) The Secretary shall publish on the Internet site of the 
Food and Drug Administration a list of persons who are accredited 
under paragraph (2). Such list shall be updated to ensure that 
the identity of each accredited person, and the particular activities 
for which the person is accredited, is known to the public. The 
updating of such list shall be no later than one month after the 
accreditation of a person under this subsection or the suspension 
or withdrawal of accreditation, or the modification of the particular 
activities for which the person is accredited. 
"(5)(A) To ensure that persons accredited under this subsection 
continue to meet the standards of accreditation, the Secretary shall 
(i) audit the performance of such persons on a periodic basis through 
the review of inspection reports and inspections by persons des-
ignated by the Secretary to evaluate the compliance status of a 
device establishment and the performance of accredited persons, 
and (ii) take such additional measures as the Secretary determines 
to be appropriate. 
"(B) The Secretary may withdraw accreditation of any person 
accredited under paragraph (2), after providing notice and an oppor-
tunity 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 purposes of this subsection. The Secretary may suspend 
the accreditation of such person during the pendency of the process 
under the preceding sentence. 
Publication. 
Deadline. 
116 STAT. 1604 
PUBLIC LAW 107-250—OCT. 26, 2002 
"(6)(A) Subject to subparagraphs (B) and (C), a device establish-
ment is eligible for inspections by persons accredited under para-
graph (2) if the following conditions are met: 
"(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'. 
"(ii) With respect to each inspection to be conducted by 
an accredited person— 
"(I) the owner or operator of the establishment submits 
to the Secretary a notice requesting clearance to use such 
a person to conduct the inspection, and the Secretary pro-
vides 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. 
"(iii) With respect to the devices that are manufactured, 
prepared, 
propagated, 
compounded, or processed by 
the 
establishment, at least one of such devices is marketed in 
the United States, and the following additional conditions are 
met: 
"(I) At least one of such devices is marketed, or is 
intended to be marketed, in one or more foreign countries, 
one of which countries certifies, accredits, or otherwise 
recognizes the person accredited under paragraph (2) and 
identified under subclause (II) of this clause. 
Deadline. 
"(II) The owner or operator of the establishment sub-
mits to the Secretary a statement that the law of a country 
in which such a device is marketed, or is intended to 
be marketed, recognizes an inspection of the establishment 
by the Secretary, and not later than 30 days after receiving 
such statement, the Secretary informs the owner or oper-
ator of the establishment that the owner or operator may 
submit a notice requesting clearance under clause (ii). 
"(iv)(I) In the case of an inspection to be conducted pursuant 
to 510(h), persons accredited under paragraph (2) did not con-
duct the two immediately preceding inspections of the establish-
ment, except that the establishment may petition the Secretary 
for a waiver of such condition. Such a waiver may be granted 
only if the petition states a commercial reason for the waiver; 
the Secretary determines that the public health would be served 
by granting the waiver; and the Secretary has conducted an 
inspection of the establishment during the four-year period 
preceding the date on which the notice under clause (ii) is 
submitted to the Secretary. Such a waiver is deemed to be 
granted only if the petition states a commercial reason for 
the waiver; the Secretary has not determined that the public 
health would be served by granting the waiver; and the owner 
or operator of the device establishment has requested in 
writing, not later than 18 months following the most recent 
inspection of such establishment by a person accredited under 
paragraph (2), that the Secretary inspect the establishment 
and the Secretary has not conducted an inspection within 30 
months after the most recent inspection. With respect to such 
a waiver that is granted or deemed to be granted, no additional 
such waiver may be granted until after the Secretary has 
conducted an inspection of the establishment. 
PUBLIC LAW 107-250—OCT. 26, 2002 
116 STAT. 1605 
"(II) In the case of an inspection to be conducted pursuant 
to 510(i), the Secretary periodically conducts inspections of 
the establishment. 
"(B)(i) The Secretary shall respond to a notice under subpara- Deadline, 
graph (A) from a device 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 accredited 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 selection. 
"(ii) The request referred to in clause (i)(II) is— 
"(I) a request to the device establishment involved to submit 
to the Secretary compliance data in accordance with clause 
(iii); or 
"(II) a request to the establishment, or to the accredited 
person identified in the notice under subparagraph (A), for 
information concerning the relationship between the establish-
ment and such accredited person, including information about 
the number of inspections of the establishment, or other 
establishments owned or operated by the owner or operator 
of the establishment, that have been conducted by the accred-
ited person. 
The Secretary may make both such requests. 
"(iii) The compliance data to be submitted by a device establish-
ment under clause (ii) are data describing whether the quality 
controls of the establishment have been sufficient for ensuring 
consistent compliance with current good manufacturing 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 manufacturing 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 compliance data the 
Secretary deems necessary. Data under the preceding sentence 
shall demonstrate to the Secretary whether the establishment has 
facilitated consistent compliance by promptly correcting any compli-
ance problems identified in such inspections. 
"(iv) Not later than 60 days after receiving compliance data Deadline. 
under clause (iii) from a device establishment, the Secretary shall 
provide or deny clearance under subparagraph (A). The Secretary 
may deny clearance if the Secretary determines that the establish-
ment has failed to demonstrate consistent compliance for purposes 
of clause (iii). The Secretary shall provide to the establishment 
a statement of such reasons for such determination. If the Secretary 
fails to provide such statement to the establishment within such 
60-day period, 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 information sought by the request, 
the Secretary shall agree to, or reject, the selection of such person 
by the device establishment involved. The Secretary may reject 
116 STAT. 1606 
PUBLIC LAW 107-250—OCT. 26, 2002 
the selection if the Secretary provides to the estabHshment a state-
ment 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 between 
the establishment and such accredited person. 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 accredited 
person by a device establishment, the establishment may make 
an additional selection of an accredited person by submitting to 
the Secretary a notice that identifies the additional selection. 
Clauses (i) and (ii), and subclause (I) of this clause, apply to the 
selection of an accredited person through a notice under the pre-
ceding 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 a device 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 establish-
Deadline. 
ment 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 inspection of 
the establishment by a person accredited under paragraph (2) as 
'official action indicated', the establishment, if otherwise eligible 
under subparagraph (A), is eligible for further inspections by per-
sons 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 resolved, 
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 clearance 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 
device 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 accredited by the Secretary 
under paragraph (2). If the Secretary denies such petition, the 
Secretary shall provide the establishment with such reasons 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 establishment 
has not been inspected by the Secretary in accordance with section 
510(h), or has not during such period been inspected pursuant 
to section 510(i), as applicable, the establishment is eligible for 
further inspections by accredited persons. 
"(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 describe each observation. Addition-
ally, such accredited person shall prepare an inspection report 
PUBLIC LAW 107-250—OCT. 26, 2002 
116 STAT. 1607 
(including for inspections classified as 'no action indicated') in a 
form and manner consistent with such reports prepared by 
employees and officials designated by the Secretary to conduct 
inspections. 
"(B) At a minimum, an inspection report under subparagraph 
(A) shall identify the persons responsible for good manufacturing 
practice compliance at the inspected device establishment, the dates 
of the inspection, the scope of the inspection, and shall describe 
in detail each observation identified by the accredited person, iden-
tify other matters that relate to or may influence compliance with 
this Act, and describe any recommendations during the inspection 
or at the inspection's closing meeting. 
"(C) An inspection report under subparagraph (A) shall be Deadline, 
sent to the Secretary and to the designated representative of the 
inspected device establishment at the same time, but under no 
circumstances later than three weeks after the last day of the 
inspection. The report to the Secretary shall be accompanied by 
all written inspection observations previously provided to the des-
ignated representative of the establishment. 
"(D) Any statement or representation made by an employee 
or agent of a device establishment to a person accredited 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 accredited 
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 device establishment subject to inspection and 
such condition. 
"(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 any device establishment pursuant to this 
Act. 
"(10)(A) For fiscal year 2005 and each subsequent fiscal year, 
no device establishment may be inspected during the fiscal year 
involved by a person accredited under paragraph (2) i
f
— 
"(i) of the amounts appropriated for salaries and expenses 
of the Food and Drug Administration for the preceding fiscal 
year (referred to in this subparagraph as the 'first prior fiscal 
year'), the amount obligated by the Secretary for inspections 
of device establishments by the Secretary was less than the 
adjusted base amount applicable to such first prior fiscal year; 
and 
"(ii) of the amounts appropriated for salaries and expenses 
of the Food and Drug Administration for the fiscal year pre-
ceding the first prior fiscal year (referred to in this subpara-
graph as the 'second prior fiscal year'), the amount obligated 
by the Secretary for inspections of device establishments by 
the Secretary was less than the adjusted base amount 
applicable 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 compliance activities of the 
Food and Drug Administration with respect to devices (referred 
116 STAT. 1608 
PUBLIC LAW 107-250—OCT. 26, 2002 
to in this subparagraph as the 'compliance budget'), and of such 
amount, the amount that was obhgated for inspections by the 
Secretary of device establishments (referred to in this subparagraph 
as the 'inspection budget'). 
"(ii) For purposes of determinations under clause (i), the Comp-
troller 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 determinations. 
"(C) For purposes of this paragraph: 
"(i) The term 'base amount' means the inspection budget 
determined under subparagraph (B) for fiscal year 2002. 
"(ii) The term 'adjusted base amount', in the case of applica-
bility to fiscal year 2003, means an amount equal to the base 
amount increased by 5 percent. 
"(iii) The term 'adjusted base amount', with respect to 
applicability to fiscal year 2004 or any subsequent fiscal year, 
means the adjusted based amount applicable to the preceding 
year increased by 5 percent. 
"(11) The authority provided by this subsection terminates on 
October 1, 2012. 
Deadline. 
"(12) No later than four years after the enactment of this 
Reports. 
subsection the Comptroller General shall report to the Committee 
on Energy and Commerce of the House of Representatives and 
the Committee on Health, Education, Labor and Pensions of the 
Senate— 
"(A) the number of inspections pursuant to subsections 
(h) and (i) of section 510 conducted by accredited persons and 
the number of inspections pursuant to such subsections con-
ducted by Federal employees; 
"(B) the number of persons who sought accreditation under 
this subsection, as well as the number of persons who were 
accredited under this subsection; 
"(C) the reasons why persons who sought accreditation, 
but were denied accreditation, were denied; 
"(D) the number of audits conducted by the Secretary 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 sufficient to permit these assessments; 
"(E) whether this subsection is achieving the goal of 
ensuring more information about device establishment compli-
ance 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, modify, or 
terminate the program under this subsection. 
PUBLIC LAW 107-250—OCT. 26, 2002 
116 STAT. 1609 
"(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 per-
son is accredited and the name of each accredited person whose 
accreditation has been withdrawn during the year. 
"(14) Notwithstanding any provision of this subsection, this 
subsection does not have any legal effect on any agreement 
described in section 803(b) between the Secretary and a foreign 
country.". 
(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 main-
tain records" and inserting the following: "An accredited person 
described in paragraph (3) shall maintain records"; 
(2) in paragraph (2), by striking "a person accredited under 
section 523" and inserting "an accredited person described in 
paragraph (3)"; and 
(3) by adding at the end the following paragraph: 
"(3) For purposes of paragraphs (1) and (2), an accredited 
person described in this paragraph is a person who— 
"(A) is accredited under subsection (g); or 
"(B) is accredited under section 523.". 
(c) CrviL MONEY PENALTY.—Section 303(g)(1)(A) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 333(g)(1)(A)) is amended 
by adding at the end the following: "For purposes of the preceding 
sentence, a person accredited under paragraph (2) of section 704(g) 
who is substantially not in compliance with the standards of accredi-
tation under such section, or who poses a threat to public health 
or fails to act in a manner that is consistent with the purposes 
of such section, shall be considered to have violated a requirement 
of this Act that relates to devices.". 
(d) PROHIBITED ACTS.—Section 301 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 331) is amended by adding at the 
end the following: 
"(gg) The Imowing failure of a person accredited under para-
graph (2) of section 704(g) to comply with paragraph (7)(E) of 
such section; the knowing inclusion by such a person of false 
information in an inspection report under paragraph (7)(A) of such 
section; or the knowing failure of such a person to include material 
facts in such a report.". 
(e) 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 Secretary" the following: 
", or by persons accredited to conduct inspections under section 
704(g),". 
SEC. 202. THIRD PARTY REVIEW OF PREMARKET NOTIFICATION. 
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 pro-
vided 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 Deadline, 
shall conduct a study based on the experience under the program 
under this section and submit to the Committee on Energy and 
116 STAT. 1610 
PUBLIC LAW 107-250—OCT. 26, 2002 
Commerce of the House of Representatives, 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 include 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 Secretary; 
"(4) the average time period for a review under this section 
(including the time it takes for the Secretary to review a 
recommendation of an accredited person under subsection (a) 
and determine the initial device classification); 
"(5) the average time period identified in paragraph (4) 
compared to the average time period for review 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 period under para-
graph (5), the reasons for such difference; 
"(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 Secretary 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 guid-
ance has been issued; 
"(9) whether this section has in any way jeopardized or 
improved the public health; 
"(10) any impact of this section on resources available 
to the Secretary to review reports under section 510(k); and 
"(11) any suggestions 
for 
continuation, 
modification 
(including contraction or expansion of device eligibility), or 
termination of this section that the Secretary determines to 
be appropriate.". 
SEC. 
203. 
DEBARMENT 
OF 
ACCREDITED 
PERSONS. 
Section 306 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 335a) is amended by adding at the end the following sub-
section: 
"(m) 
DEVICES; MANDATORY DEBARMENT REGARDING THIRD-
PARTY INSPECTIONS AND REVIEWS.— 
"(1) IN GENERAL.—^If the Secretary finds that a person 
has been convicted of a felony under section 301(gg), the Sec-
retary shall debar such person from being accredited under 
section 523(b) or 704(g)(2) and from carrying out activities 
under an agreement described in section 803(b). 
"(2) DEBARMENT PERIOD.—The Secretary shall debar a per-
son under paragraph (1) for the following periods: 
"(A) The period of debarment of a person (other than 
an individual) shall not be less than 1 year or more than 
10 years, but if an act leading to a subsequent debarment 
imder such paragraph occurs within 10 years after such 
person has been debarred under such paragraph, the period 
of debarment shall be permanent. 
"(B) The debarment of an individual shall be perma-
nent. 
PUBLIC LAW 107-250—OCT. 26, 2002 
116 STAT. 1611 
"(3) TERMINATION OF DEBARMENT; JUDICIAL REVIEW; OTHER 
MATTERS.—Subsections (c)(3), (d), (e), (i), (j), and (1)(1) apply 
with respect to a person (other than an individual) or an 
individual who is debarred under paragraph (1) to the same 
extent and in the same manner as such subsections apply 
with respect to a person who is debarred under subsection 
(a)(1), or an individual who is debarred under subsection (a)(2), 
respectively.". 
SEC. 204. DESIGNATION AND REGULATION OF COMBINATION PROD-
UCTS. 
Section 503(g) of the Federal Food, Drug, and Cosmetic 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 Administration" 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 inserting "the agency 
center charged"; 
(2) by redesignating paragraph (4) as paragraph (5); 
(3) by inserting after paragraph (3) the following para-
graph: 
"(4)(A) Not later than 60 days after the date of the enactment Deadline. 
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 and effective premarket review of such products, and con-
sistent and appropriate postmarket regulation of like products sub-
ject to the same statutory requirements to the extent permitted 
by law. Additionally, the office shall, in determining whether a 
product is to be designated 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 
(referred to in this paragraph as the 'Office') shall have appropriate 
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 pri-
mary jurisdiction in accordance with paragraph (1) for the pre-
market review of such product. 
"(C)(i) In carrying out this subsection, the Office shall ensure 
timely and effective premarket reviews by overseeing the timeliness 
of and coordinating reviews involving more than one agency center. 
"(ii) In order to ensure the timeliness of the premarket review 
of a combination product, the agency center with primary jurisdic-
tion for the product, and the consulting agency center, shall be 
responsible to the Office with respect to the timeliness of the 
premarket review. 
"(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 requirements to the 
extent permitted by law. 
"(E)(i) Any dispute regarding the timeliness of the premarket 
review of a combination product may be presented to the Office 
for resolution, unless the dispute is clearly premature. 
116 STAT. 1612 
PUBLIC LAW 107-250—OCT. 26, 2002 
Federal Register, 
publication. 
Notice. 
Deadline. 
Reports. 
21 u s e 360e 
note. 
Deadline. 
"(ii) During the review process, any dispute regarding the sub-
stance of the premarket review may be presented to the Commis-
sioner of Food and Drugs after first being considered 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 Of^ce in resolving the substantive dispute. 
"(F) The Secretary, acting through the Office, shall review 
each agreement, guidance, or practice of the Secretary that is spe-
cific to the assignment of combination products to agency centers 
and shall determine whether the agreement, guidance, or practice 
is consistent with the requirements 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 availability 
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 contin-
ued, modified, revised, or eliminated. 
"(G) Not later than one year after the date of the enactment 
of this paragraph and annually thereafter, the Secretary shall report 
to the appropriate committees of Congress on the activities and 
impact of the Office. The report shall include provisions— 
"(i) describing the numbers and types of combination prod-
ucts under review and the timeliness in days of such assign-
ments, reviews, and dispute resolutions; 
"(ii) identifying the number of premarket reviews of such 
products that involved a consulting agency center; and 
"(iii) describing improvements 
in the consistency of 
postmarket regulation of combination products. 
"(H) Nothing in this paragraph shall be construed to limit 
the regulatory authority of any agency center."; and 
(4) in paragraph (5) (as redesignated by paragraph (2) 
of this section)— 
(A) by redesignating subparagraphs (A) and (B) as 
subparagraphs (B) and (C), respectively; 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 Administra-
tion.". 
SEC. 205. 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 Radiological 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 performance 
including, but not limited to, the allocation of additional resources. 
PUBLIC LAW 107-250—OCT. 26, 2002 
116 STAT. 1613 
Such report also shall include the Secretary's specific recommenda-
tion on whether responsibility for regulating such devices should 
be reassigned to those persons within the Food and Drug Adminis-
tration 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. 206. ELECTRONIC LABELING. 
Section 502(f) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 352(f)) is amended by adding at the end the following: 
"Required labeling for prescription devices intended for use in 
health care facilities may be made available solely by electronic 
means provided that the labeling complies with all applicable 
requirements of law and, that the manufacturer affords health 
care facilities the opportunity to request the labeling in paper 
form, and after such request, promptly provides the health care 
facility the requested information without additional cost.". 
SEC. 207. 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 sub-
mitted 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 request for waiver of such 
requirement because use of electronic means is not reasonable 
for the person requesting such waiver.". 
SEC. 208. INTENDED USE. 
Section 513(i)(l)(E) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360c(i)(l)(E)) is amended by striking clause (iv). 
SEC. 209. MODULAR REVIEW. 
Section 515(c) of the Federal Food, Drug, and Cosmetic 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 any portion of 
the application that the applicant and the Secretary agree is com-
plete, ready, and appropriate for review, except that such require-
ment does not apply, and the Secretary has discretion whether 
to accept and review such portion, during any period in which, 
under section 738(g), the Secretary does not have the authority 
to collect fees under section 738(a). 
"(B) Each portion of a submission reviewed under subparagraph 
(A) and found acceptable by the Secretary shall not be further 
reviewed after receipt of an application that satisfies the require-
ments of paragraph (1), unless an issue of safety or effectiveness 
provides the Secretary reason to review such accepted portion. 
"(C) Whenever the Secretary determines that a portion of a 
submission under subparagraph (A) is unacceptable, the Secretary 
shall, in writing, provide to the applicant a description of any 
deficiencies in such portion and identify the information that is 
required to correct these deficiencies, unless the applicant is no 
longer pursuing the application.". 
116 STAT. 1614 
PUBLIC LAW 107-250—OCT. 26, 2002 
21 u s e 360/ 
note. 
Deadline. 
21 u s e 360j 
note. 
Deadline. 
SEC. 210. PEDIATRIC EXPERTISE REGARDING CLASSIFICATION-PANEL 
REVIEW OF PREMARKET APPLICATIONS. 
Section 515(c) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360e(c)), as amended by section 302(c)(2)(A) of this 
Act, is amended in paragraph (3) by adding at the end the following: 
"Where appropriate, the Secretary shall ensure that such panel 
includes, or consults with, one or more pediatric experts.". 
SEC. 211. INTERNET LIST OF CLASS II DEVICES EXEMPTED FROM 
REQUIREMENT OF PREMARKET NOTIFICATION. 
Section 510(m)(l) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360(m)(l)) 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. 
212. 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 "Secretary") 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 deter-
minations made in the study under subsection (a) include deter-
minations of— 
(1) whether postmarket surveillance studies of implanted 
medical devices are of long enough duration to evaluate the 
impact of growth and development 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 postmarket surveillance by the Food and 
Drug Administration of medical devices used in pediatric popu-
lations is sufficient to provide adequate safeguards for such 
populations, taking into account the Secretary'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 adverse reaction reports, registries, and other postmarket 
surveillance activities. 
(c) REPORT TO CONGRESS.—The Secretary shall ensure 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 Secretary for administrative or legislative 
changes to the system of postmarket surveillance referred to in 
such subsection. 
SEC. 213. GUIDANCE REGARDING PEDIATRIC DEVICES. 
Not later than 270 days after the date of the enactment of 
this Act, the Secretary of Health and Human Services shall issue 
guidance on the following: 
PUBLIC LAW 107-250—OCT. 26, 2002 
116 STAT. 1615 
(1) The type of information necessary to provide reasonable 
assurance of the safety and effectiveness of medical devices 
intended for use in pediatric populations. 
(2) Protections for pediatric subjects in clinical investiga-
tions of the safety or effectiveness of such devices. 
SEC. 214. BREAST IMPLANTS; STUDY BY COMPTROLLER GENERAL. 
42 USC 289g-3 
(a) IN GENERAL.—The Comptroller General of the United States 
shall conduct a study to determine the following with respect to 
breast implants: 
(1) The content of information typically provided by health 
professionals to women who consult with such professionals 
on the issue of whether to undergo 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, and at what point in the 
process of determining whether to undergo surgery is such 
information provided. 
(3) Whether the information presented, as a whole, provides 
a complete and acciu-ate discussion of the risks and benefits 
of breast implants, and the extent to which women who receive 
such information understand the risks and benefits. 
(4) The number of adverse events that have been reported, 
and whether such events have been adequately investigated. 
(5) With respect to women who participate as subjects 
in research being carried out regarding the safety and effective-
ness 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 the extent to which such 
information is updated. 
(B) Whether such process provides written expla-
nations 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. 
(b) REPORT.—The Comptroller General shall submit to the Con-
gress 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 implanted to augment 
or reconstruct the female breast. 
SEC. 
215. BREAST IMPLANTS; RESEARCH THROUGH NATIONAL 
INSTITUTES OF HEALTH. 
(a) REPORT ON STATUS OF CURRENT RESEARCH.—Not later than DeadUne. 
180 days after the date of the enactment of this Act, the Director Reports. 
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. 
42 USC 289g-3. 
"(a) IN GENERAL.—The Director of NIH may conduct or support 
research to examine the long-term health implications of silicone 
99-194 O - 03 - 27 : QL 3 Part 2 
116 STAT. 1616 
PUBLIC LAW 107-250—OCT. 26, 2002 
breast implants, both gel and saline filled. Such research studies 
may include the following: 
"(1) Developing and examining techniques to measure con-
centrations of silicone in body fluids and tissues. 
"(2) Surveillance of recipients of silicone breast implants, 
including long-term outcomes and local complications. 
"(b) DEFINITION.—For purposes of this section, the term 'breast 
implant' means a breast prosthesis that is implanted to augment 
or reconstruct the female breast.". 
TITLE III—ADDITIONAL AMENDMENTS 
SEC. 301. IDENTIFICATION OF MANUFACTURER OF MEDICAL 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 thereto, 
prominently and conspicuously bears the name of the manufacturer 
of the device, a generally recognized abbreviation of such name, 
or a unique and generally recognized symbol identifying such manu-
facturer, except that the Secretary 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.". 
21 use 352 note. 
(b) EFFECTIVE DATE.—The amendment made by subsection (a) 
takes effect 18 months after the date of the enactment of this 
Act, and only applies to devices introduced or delivered for introduc-
tion into interstate commerce £ifter 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 
.' 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 interstate commerce after such effective 
date. 
21 use 352 note. 
(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: 
"(oXD 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 subsection must, in 
order to ensure that the device is substantially equivalent 
to a predicate device, include validation data, the t3^es of 
which shall be specified by the Secretary, regarding cleaning 
and sterilization, and functional performance demonstrating 
PUBLIC LAW 107-250—OCT. 26, 2002 
116 STAT. 1617 
Federal Register, 
publication. 
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 person submitting 
the premarket notification. Within six months after enactment 
of this subsection, the Secretary shall publish in the Federal 
Register a list of the tjrpes so identified, and shall revise the 
list as appropriate. 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 Deadline, 
was sulamitted 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 period, 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 submitted to the Secretary. After the submission of the 
validation data to the Secretary, the Secretary may not deter-
mine 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 
subsection (k); (ii) the Secretary finds the data to be acceptable 
and issues a letter; or (iii) the Secretary determines that the 
device is not substantially equivalent to a predicate device. 
Upon a determination that a device is not substantially equiva-
lent 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 previously 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 validation data required 
under subparagraph (A). 
"(2) With respect to critical or semi-critical reprocessed single-
use devices that, under subsection (1) or (m), are exempt from 
the requirement of submitting reports under subsection (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 Secretary 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 termi-
nated upon the publication of the list. For each report under 
subsection (k) submitted pursuant to this subparagraph the 
Secretary shall require the validation data described in para-
graph (1)( 
A). 
Federal Register, 
publication. 
116 STAT. 1618 
PUBLIC LAW 107-250—OCT. 26, 2002 
"(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 exemption 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 report 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 Sec-
retary determines by order that the device is substantially 
equivalent to a pre(Ucate device; or (iii) the Secretary deter-
mines 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. 
Deadlines. 
"(C) In the case of semi-critical devices, the initial list 
under subparagraph (A) shall be published not later than 18 
months after the effective date of this subsection. In the case 
of critical devices, the initial list under such subparagraph 
shall be published not later than six months after such effective 
date. 
"(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 required in such subparagraph. 
"(E) The termination under subparagraph (A) of an exemp-
tion under subsection (1) or (m) for a critical or semicritical 
reprocessed single-use device does not terminate the exemption 
under subsection (1) or (m) for the original device.". 
(c) PREMARKET REPORT.—Section 515 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360e) is amended— 
(1) in subsection (a), in the matter after and below para-
graph (2), by inserting before the period the following: "or, 
as applicable, an approval under subsection (c)(2) of a report 
seeking premarket approval"; and 
(2) in subsection (c)— 
(A) by redesignating paragraph (2) as paragraph (3); 
and 
(B) by inserting after paragraph (1) the following para-
graph: 
"(2)(A) Any person may file with the Secretary a report seeking 
premarket approval for a class III device referred to in subsection 
(a) that is a reprocessed single-use device. Such a report shall 
contain the following: 
"(i) The device name, including both the trade or propri-
etary 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 performance standards 
under section 514. 
PUBLIC LAW 107-250—OCT. 26, 2002 
116 STAT. 1619 
"(iv) Proposed labels, labeling, and advertising sufficient 
to describe the device, its intended use, and directions for 
use. 
"(v) Full reports of all information, published or known 
to or which should be reasonably known to the applicant, con-
cerning investigations which have been made to show whether 
or not the device is safe or effective. 
"(vi) A description of the device's components, 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 Regula-
tions. 
"(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, 
including 
information of the type required in paragraph (1) for an applica-
tion under such paragraph, that the Secretary determines is 
necessary to determine whether there is reasonable assurance 
of safety and effectiveness for the reprocessed device. 
"(xii) Validation data described in section 510(o)(l)(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 such report. 
"(B) In the case of a class III device referred to in subsection 
(a) that is a reprocessed single-use device: 
"(i) Subparagraph (A) of this paragraph applies in lieu 
of paragraph (1). 
"(ii) Subject to clause (i), the provisions of this section 
apply to a report under subparagraph (A) to the same extent 
and in the same manner as such provisions apply to an applica-
tion under paragraph (1). 
"(iii) Each reference in other sections of this Act to an 
application under this section, other than such a reference 
in section 737 or 738, shall be considered to be a reference 
to a report under subparagraph (A). 
"(iv) Each reference in other sections of this Act to a device 
for which an application under this section has been approved, 
or has been denied, suspended, or withdrawn, other than such 
a reference in section 737 or 738, shall be considered to be 
a reference to a device for which a report under subparagraph 
(A) has been approved, or has been denied, suspended, or 
withdrawn, respectively.". 
(d) 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: 
"(11)(1) The term 'single-use device' means a device that is 
intended for one use, or on a single patient during a single proce-
dure. 
116 STAT. 1620 
PUBLIC LAW 107-250—OCT. 26, 2002 
"(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 additional single use on a 
patient. 
The 
subsequent 
processing 
and 
manufacture 
of a 
reprocessed single-use device shall result in a device that is 
reprocessed within the meaning of this definition. 
"(B) A single-use device that meets the definition under clause 
(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, including 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)(l) The term 'critical reprocessed single-use device' 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 device' means 
a reprocessed single-use device that is intended to contact intact 
mucous membranes and not penetrate normally sterile areas of 
the body.". 
SEC. 303. MEDWATCH. 
Deadline. 
Not later than 6 months after the date of the enactment of 
this Act, the Secretary of Health and Human Services shall modify 
the MedWatch mandatory and voluntary forms to facilitate the 
reporting of information by user facilities or distributors as appro-
priate relating to reprocessed single-use devices, including the name 
of the reprocessor and whether the device has been reused. 
Approved October 26, 2002. 
LEGISLATIVE HISTORY—H.R. 5651: 
CONGRESSIONAL RECORD, Vol. 148 (2002): 
Oct. 16, considered and passed House. 
Oct. 17, considered and passed Senate. 
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 38 (2002): 
Oct. 26, 28, Presidential remarks and statement.