SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Medical Device User Fee and Modernization Act of
2002’’.
(b) TABLE OF CONTENTS.—The table of contents for
this Act is as follows:
Sec. 1. Short title; table of contents.
TITLE I—FEES RELATED TO MEDICAL DEVICES
Sec. 101. Findings.
Sec. 102. Establishment of program.
Sec. 103. Annual reports.
Sec. 104. Postmarket surveillance.
Sec. 105. Consultation.
Sec. 106. Effective date.
Sec. 107. Sunset clause.
TITLE II—AMENDMENTS REGARDING REGULATION OF MEDICAL
DEVICES
Sec. 201. Inspections by accredited persons.
Sec. 202. Third party review of premarket notification.
Sec. 203. Designation and regulation of combination products.
Sec. 204. Report on certain devices.
Sec. 205. Electronic labeling.
Sec. 206. Electronic registration.
Sec. 207. Intended use.
Sec. 208. Modular review.
Sec. 209. Pediatric expertise regarding classification-panel review of premarket
applications.
Sec. 210. Internet list of class II devices exempted from requirement of pre-
market notification.
Sec. 211. Study by Institute of Medicine of postmarket surveillance regarding
pediatric populations.
Sec. 212. Guidance regarding pediatric devices.
Sec. 213. Breast implants; study by Comptroller General.
Sec. 214. Breast implants; research through National Institutes of Health.
TITLE III—ADDITIONAL AMENDMENTS
Sec. 301. Identification of manufacturer of medical devices.
Sec. 302. Single-use medical devices.
TITLE I—FEES RELATED TO
MEDICAL DEVICES
SEC. 101. FINDINGS.
The Congress finds that—
(1) prompt approval and clearance of safe and
effective devices is critical to the improvement of the
public health so that patients may enjoy the benefits
of devices to diagnose, treat, and prevent disease;
(2) the public health will be served by fur-
nishing additional funds for the review of devices so
that statutorily mandated deadlines may be met; and
(3) the fees authorized by the amendment made
by section 102 will be dedicated to meeting the goals
identified in the letters from the Secretary of Health
and Human Services to the Committee on Energy
and Commerce of the House of Representatives and
the Committee on Health, Education, Labor, and
Pensions of the Senate.
SEC. 102. ESTABLISHMENT OF PROGRAM.
(a) IN GENERAL.—Subchapter C of chapter VII of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379F et seq.) is amended by adding at the end the fol-
lowing part:
‘‘PART 3—FEES RELATING TO DEVICES
‘‘SEC. 737. DEFINITIONS.
‘‘For purposes of this subchapter:
‘‘(1) The term ‘premarket application’ means—
‘‘(A) an application for approval of a de-
vice submitted under section 515(c) or section
351 of the Public Health Service Act; or
‘‘(B) a product development protocol de-
scribed in section 515(f).
Such term does not include a supplement, a pre-
market report, or a premarket notification submis-
sion.
‘‘(2) The term ‘premarket report’ means a re-
port submitted under section 510(o)(3).
‘‘(3) The term ‘premarket notification submis-
sion’ means a report submitted under section
510(k).
‘‘(4)(A) The term ‘supplement’, with respect to
a panel-track supplement, a 180-day supplement, a
real-time supplement, or an efficacy supplement,
means a request to the Secretary to approve a
change in a device for which—
‘‘(i) an application has been approved
under section 515(d) or under section 351 of
the Public Health Service Act; or
‘‘(ii) a notice of completion has become ef-
fective under section 515(f).
‘‘(B) The term ‘panel-track supplement’ means
a supplement to an approved premarket application
under section 515 that requests a significant change
in design or performance of the device, or a new in-
dication for use of the device, and for which clinical
data are generally necessary to provide a reasonable
assurance of safety and effectiveness.
‘‘(C) The term ‘180-day supplement’ means a
supplement to an approved premarket application
under section 515 that is not a panel-track supple-
ment and requests a significant change in compo-
nents, materials, design, specification, software,
color additives, or labeling.
‘‘(D) The term ‘real-time supplement’ means a
supplement to an approved premarket application
under section 515 that requests a minor change to
the device, such as a minor change to the design of
the device, software, manufacturing, sterilization, or
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 re-
view of premarket applications, premarket re-
ports, supplements, and premarket notification
submissions.
‘‘(B) The issuance of action letters that
allow the marketing of devices or which set
forth in detail the specific deficiencies in such
applications, reports, supplements, or submis-
sions and, where appropriate, the actions nec-
essary to place them in condition for approval.
‘‘(C) The inspection of manufacturing es-
tablishments and other facilities undertaken as
part of the Secretary’s review of pending pre-
market 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 investigational
device exemption under section 520(g) and ac-
tivities conducted in anticipation of the submis-
sion of such applications under section 505(i)
or 520(g).
‘‘(F) The development of guidance, policy
documents, or regulations to improve the proc-
ess for the review of premarket applications,
premarket reports, supplements, and premarket
notification submissions.
‘‘(G) The development of voluntary test
methods, consensus standards, or mandatory
performance standards under section 514 in
connection with the review of such applications,
reports, supplements, or submissions and re-
lated activities.
‘‘(H) The provision of technical assistance
to device manufacturers in connection with the
submission of such applications, reports, supple-
ments, or submissions.
‘‘(I) Any activity undertaken under section
513 or 515(i) in connection with the initial clas-
sification or reclassification of a device or under
section 515(b) in connection with any require-
ment for approval of a device.
‘‘(J) Evaluation of postmarket studies re-
quired as a condition of an approval of a pre-
market application under section 515 or section
351 of the Public Health Service Act.
‘‘(K) Compiling, developing, and reviewing
information on relevant devices to identify safe-
ty and effectiveness issues for devices subject to
premarket applications, premarket reports, sup-
plements, or premarket notification submis-
sions.
‘‘(6) The term ‘costs of resources allocated for
the process for the review of device applications’
means the expenses incurred in connection with the
process for the review of device applications for—
‘‘(A) officers and employees of the Food
and Drug Administration, contractors of the
Food and Drug Administration, advisory com-
mittees, and costs related to such officers, em-
ployees, and committees and to contracts with
such contractors;
‘‘(B) management of information, and the
acquisition, maintenance, and repair of com-
puter resources;
‘‘(C) leasing, maintenance, renovation, and
repair of facilities and acquisition, maintenance,
and repair of fixtures, furniture, scientific
equipment, and other necessary materials and
supplies; and
‘‘(D) collecting fees and accounting for re-
sources allocated 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 aver-
age) for April of the preceding fiscal year divided by
such Index for April 2002.
‘‘(8) The term ‘affiliate’ means a business enti-
ty that has a relationship with a second business en-
tity if, directly or indirectly—
‘‘(A) one business entity controls, or has
the power to control, the other business entity;
or
‘‘(B) a third party controls, or has power
to control, both of the business entities.
‘‘SEC. 738. AUTHORITY TO ASSESS AND USE DEVICE FEES.
‘‘(a) TYPES OF FEES.—Beginning on the date of the
enactment of the Medical Device User Fee and Moderniza-
tion Act of 2002, the Secretary shall assess and collect
fees in accordance with this section as follows:
‘‘(1) PREMARKET
APPLICATION, PREMARKET
REPORT, SUPPLEMENT, AND SUBMISSION FEE.—
‘‘(A) IN GENERAL.—Except as provided in
subparagraph (B) and subsection (d), each per-
son who submits any of the following, on or
after October 1, 2002, shall be subject to a fee
established under subsection (c)(5) for the fis-
cal year involved in accordance with the fol-
lowing:
‘‘(i) A premarket application.
‘‘(ii) For a premarket report, a fee
equal to the fee that applies under clause
(i).
‘‘(iii) For a panel track supplement, a
fee equal to the fee that applies under
clause (i).
‘‘(iv) For a 180-day supplement, a fee
equal to 21.5 percent of the fee that ap-
plies under clause (i), subject to any ad-
justment under subsection (c)(3).
‘‘(v) For a real-time supplement, a fee
equal to 7.2 percent of the fee that applies
under clause (i).
‘‘(vi) For an efficacy supplement, a
fee equal to the fee that applies under
clause (i).
‘‘(vii) For a premarket notification
submission, a fee equal to 1.75 percent of
the fee that applies under clause (i), sub-
ject to any adjustment under subsection
(c)(3).
‘‘(B) EXCEPTIONS.—
‘‘(i) HUMANITARIAN DEVICE EXEMP-
TION.—A device for which a humanitarian
device exemption has been granted is not
subject to the fees established in subpara-
graph (A).
‘‘(ii) 
FURTHER
MANUFACTURING
USE.—No fee shall be required under sub-
paragraph (A) for the submission of a pre-
market application under section 351 of
the Public Health Service Act for a prod-
uct licensed for further manufacturing use
only.
‘‘(iii) STATE
OR
FEDERAL
GOVERN-
MENT
SPONSORS.—No fee shall be re-
quired under subparagraph (A) for a pre-
market application, premarket report, sup-
plement, or premarket notification submis-
sion submitted by a State or Federal Gov-
ernment entity unless the device involved is
to be distributed commercially.
‘‘(iv) PREMARKET NOTIFICATIONS BY
THIRD PARTIES.—No fee shall be required
under subparagraph (A) for a premarket
notification submission reviewed by an ac-
credited person pursuant to section 523.
‘‘(v) 
PEDIATRIC
CONDITIONS
OF
USE.—
‘‘(I) IN GENERAL.—No fee shall
be required under subparagraph (A)
for a premarket application or pre-
market notification submission if the
proposed conditions of use for the de-
vice involved are solely for a pediatric
population. No fee shall be required
under such subparagraph for a sup-
plement if the sole purpose of the sup-
plement is to propose conditions of
use for a pediatric population.
‘‘(II) SUBSEQUENT PROPOSAL OF
ADULT CONDITIONS OF USE.—In the
case of a person who submits a pre-
market application for which, under
subclause (I), a fee under subpara-
graph (A) is not required, any supple-
ment to such application that pro-
poses 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 sub-
paragraph (A) shall be due upon submission of
the premarket application, premarket report,
supplement, or premarket notification submis-
sion except that invoices for applications sub-
mitted between October 1, 2002, and the date
of the enactment of the Medical Device User
Fee and Modernization Act of 2002 shall be
payable on October 30, 2002. Applicants sub-
mitting portions of applications pursuant to
section 515(c)(3) shall pay such fees upon sub-
mission of the first portion of such applications.
The fees credited to fiscal year 2003 under this
section shall include all fees payable from Octo-
ber 1, 2002, through September 30, 2003.
‘‘(D) REFUNDS.—
‘‘(i) APPLICATION REFUSED FOR FIL-
ING.—The Secretary shall refund 75 per-
cent of the fee paid under subparagraph
(A) for any application or supplement that
is refused for filing.
‘‘(ii) APPLICATION
WITHDRAWN
BE-
FORE FILING.—The Secretary shall refund
75 percent of the fee paid under subpara-
graph (A) for any application or supple-
ment that is withdrawn prior to the filing
decision of the Secretary.
‘‘(iii) APPLICATION WITHDRAWN BE-
FORE FIRST ACTION.—After receipt of a
request for a refund of the fee paid under
subparagraph (A) for a premarket applica-
tion, 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 al-
ready expended on the review of such ap-
plication, report, or supplement. The Sec-
retary shall have sole discretion to refund
a fee or portion of the fee under this sub-
paragraph. A determination by the Sec-
retary concerning a refund under this
paragraph shall not be reviewable.
‘‘(b) FEE REVENUE AMOUNTS.—Except as provided
in subsections (c), (d), (f), and (g), the fees under sub-
section (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 this Act requiring the
Secretary to fund additional costs of the retirement of
Federal personnel, fee revenue amounts under this sub-
section shall be increased in each year by the amount nec-
essary 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 subsection (b) shall be adjusted by the
Secretary by notice, published in the Federal Reg-
ister, for a fiscal year to reflect the greater of—
‘‘(A) the total percentage change that oc-
curred in the Consumer Price Index for all
urban consumers (all items; U.S. city average)
for the 12 month period ending June 30 pre-
ceding the fiscal year for which fees are being
established, or
‘‘(B) the total percentage change for the
previous fiscal year in basic pay under the Gen-
eral Schedule in accordance with section 5332
of title 5, United States Code, as adjusted by
any locality-based comparability payment pur-
suant to section 5304 of such title for Federal
employees stationed in the District of Columbia.
The adjustment made each fiscal year by this sub-
section shall be added on a compounded basis to the
sum of all adjustments made each fiscal year after
fiscal year 2003 under this subsection.
‘‘(2) WORKLOAD ADJUSTMENT.—After the fee
revenues established in subsection (b) are adjusted
for a fiscal year for inflation in accordance with
paragraph (1), the fee revenues shall, beginning 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 Secretary based on a weighted average
of the change in the total number of premarket
applications, investigational new device applica-
tions, premarket reports, supplements, and pre-
market notification submissions submitted to
the Secretary. The Secretary shall publish in
the Federal Register the fee revenues and fees
resulting from the adjustment and the sup-
porting methodologies.
‘‘(B) Under no circumstances shall the ad-
justment result in fee revenues for a fiscal year
that are less than the fee revenues for the fiscal
year established in subsection (b), as adjusted
for inflation under paragraph (1).
‘‘(3) COMPENSATING ADJUSTMENT.—After the
fee revenues established in subsection (b) are ad-
justed for a fiscal year for inflation in accordance
with paragraph (1), and for workload in accordance
with paragraph (2), the fee revenues shall, beginning
with fiscal year 2004, be adjusted further each fiscal
year, if necessary, to reflect the cumulative amount
by which collections for previous fiscal years, begin-
ning with fiscal year 2003, fell below the cumulative
revenue amounts for such fiscal years specified in
subsection (b), adjusted for such fiscal years for in-
flation in accordance with paragraph (1), and for
workload in accordance with paragraph (2). Only
fees for 180 day supplements and premarket notifi-
cation submissions shall be increased to generate
compensating adjustment revenues.
‘‘(4) FINAL
YEAR
ADJUSTMENT.—For fiscal
year 2007, the Secretary may, in addition to adjust-
ments under paragraphs (1) and (2), further in-
crease the fees and fee revenues established in sub-
section (b) if such adjustment is necessary to pro-
vide for not more than three months of operating re-
serves 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 in-
crease shall be contained in the annual notice estab-
lishing fee revenues and fees for fiscal year 2007. If
the Secretary has carryover user fee balances for
such process in excess of three months of such oper-
ating reserves, the adjustment under this paragraph
shall not be made.
‘‘(5) ANNUAL
FEE
SETTING.—The Secretary
shall, 60 days before the start of each fiscal year
after September 30, 2002, establish, for the next fis-
cal 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, except that the fees
established for fiscal year 2003 shall be based on a
premarket application fee of $139,000.
‘‘(6) LIMIT.—The total amount of fees charged,
as adjusted under this subsection, for a fiscal year
may not exceed the total costs for such fiscal year
for the resources allocated for the process for the re-
view of device applications.
‘‘(d) SMALL BUSINESS FEE WAIVER AND FEE RE-
DUCTION.—
‘‘(1) IN GENERAL.—The Secretary shall grant a
waiver of the fee required under subsection (a) for
one premarket application, or one premarket report,
where the Secretary finds that the applicant involved
is a small business submitting its first premarket
application to the Secretary, or its first premarket
report, respectively, for review. In addition, for sub-
sequent premarket applications, premarket reports,
and supplements where the Secretary finds that the
applicant involved is a small business, the fees speci-
fied 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
SMALL
BUSI-
NESSES.—
‘‘(A) DEFINITION.—
‘‘(i) For purposes of this subsection,
the term ‘small business’ means an entity
that reported $10,000,000 or less of gross
receipts or sales in its most recent Federal
income tax return for a taxable year, in-
cluding such returns of all of its affiliates,
partners, or parent firms.
‘‘(ii) The Secretary may adjust the
$10,000,000 
threshold 
established 
in
clause (i) if the Secretary has evidence
from actual experience that this threshold
results in a reduction in revenues from
premarket applications, premarket reports,
and supplements that is 13 percent or
more than would occur without small busi-
ness exemptions and lower fee rates. To
adjust this threshold, the Secretary shall
publish a notice in the Federal Register
setting out the rationale for the adjust-
ment, and the new threshold.
‘‘(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 defini-
tion under subparagraph (A) by submission of
a copy of its most recent Federal income tax re-
turn for a taxable year, which shows an amount
of gross sales or receipts that is less than the
maximum established in subparagraph (A). The
applicant shall certify that the information pro-
vided is a true and accurate copy of the appli-
cant’s actual tax forms as submitted to the In-
ternal Revenue Service.
‘‘(C) REDUCED
FEES.—Where the Sec-
retary finds that the applicant involved meets
the definition under subparagraph (A), the fees
established under subsection (c)(5) may be paid
at reduced rates as follows:
‘‘(i) 38 percent of the fee established
under subsection (c)(5) for a premarket
application, a premarket report, a panel-
track supplement, or an efficacy supple-
ment.
‘‘(ii) 44 percent of the fee established
under subsection (c)(5) for a 180-day sup-
plement to a medical device application.
‘‘(iii) 25 percent of the fee established
under subsection (c)(5) for a real-time sup-
plement to a premarket application.
This subsection may not be construed as au-
thorizing any reduction in the fee established
under subsection (c)(5) for a premarket notifi-
cation submission.
‘‘(D) REQUEST FOR FEE WAIVER OR RE-
DUCTION.—An applicant seeking a fee waiver
or reduction under this subsection shall submit
supporting information to the Secretary at least
60 days before the fee is required pursuant to
subsection (a).
‘‘(e) EFFECT OF FAILURE TO PAY FEES.—A pre-
market application, premarket report, supplement, or pre-
market notification submission submitted by a person sub-
ject to fees under subsection (a) shall be considered incom-
plete and shall not be accepted for filing by the Secretary
until all fees owed by such person have been paid.
‘‘(f) CONDITIONS.—
‘‘(1) PERFORMANCE GOALS THROUGH FISCAL
YEAR 2005; TERMINATION OF PROGRAM AFTER FIS-
CAL YEAR 2005.—With respect to the amount that,
under the salaries and expenses account of the Food
and Drug Administration, is appropriated for a fis-
cal 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 in-
volved in any letter referred to in section
101(3) of the Medical Device User Fee and
Modernization Act of 2002 (referred to in this
paragraph as ‘performance goals’) if the
amount so appropriated for such fiscal year, ex-
cluding the amount of fees appropriated for
such fiscal year, is equal to or greater than
$205,720,000 multiplied by the adjustment fac-
tor applicable to the fiscal year.
‘‘(ii) For each of the fiscal years 2003 and
2004, if the amount so appropriated for the fis-
cal year involved, excluding the amount of fees
appropriated for such fiscal year, is less than
the amount that applies under clause (i) for
such 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 avail-
able 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 per-
formance goals identified for such fiscal
year, and whether the Secretary will be
able to meet all performance goals identi-
fied 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 goals identified for
the fiscal year if the total of the amounts so ap-
propriated for fiscal years 2003 through 2005,
excluding the amount of fees appropriated for
such fiscal years, is equal to or greater than the
sum of—
‘‘(I) $205,720,000 multiplied by the
adjustment factor applicable to fiscal year
2003;
‘‘(II) $205,720,000 multiplied by the
adjustment factor applicable to fiscal year
2004; and
‘‘(III) $205,720,000 multiplied by the
adjustment factor applicable to fiscal year
2005.
‘‘(ii) For fiscal year 2005, if the total of
the amounts so appropriated for fiscal years
2003 through 2005, excluding the amount of
fees 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 avail-
able 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 per-
formance goals identified for such fiscal
year, and whether the Secretary will be
able to meet all performance goals identi-
fied 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, ex-
cluding the amount of fees appropriated for
such fiscal years, is less than the sum of—
‘‘(i) $205,720,000 multiplied by the
adjustment factor applicable to fiscal year
2006; and
‘‘(ii) an amount equal to the sum that
applies for purposes of subparagraph
(B)(i).
‘‘(D) For fiscal year 2007, fees may not be
assessed under subsection (a) for the fiscal
year, and the Secretary is not expected to meet
any performance goals identified for the fiscal
year, if—
‘‘(i) the amount so appropriated for
the fiscal year, excluding the amount of
fees appropriated for the fiscal year, is less
than $205,720,000 multiplied by the ad-
justment 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 Sec-
retary may assess and collect such fees, without any
modification in the rate for premarket applications,
supplements, premarket reports, and premarket no-
tification submissions, and at any time in such fiscal
year, notwithstanding the provisions of subsection
(a) relating to the date fees are to be paid.
‘‘(g) CREDITING AND AVAILABILITY OF FEES.—
‘‘(1) IN GENERAL.—Fees authorized under sub-
section (a) shall be collected and available for obliga-
tion only to the extent and in the amount provided
in advance in appropriation Acts. Such fees are au-
thorized to be appropriated to remain available until
expended. Such sums as may be necessary may be
transferred from the Food and Drug Administration
salaries and expenses appropriation account without
fiscal year limitation to such appropriation account
for salaries and expenses with such fiscal year limi-
tation. The sums transferred shall be available solely
for the process for the 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 appropriation Acts, or
otherwise made available for obligation, for
such fiscal year, and
‘‘(ii) shall only be collected and avail-
able to defray increases in the costs of the
resources allocated for the process for the
review of device applications (including in-
creases in such costs for an additional
number of full-time equivalent positions in
the Department of Health and Human
Services to be engaged in such process)
over such costs, excluding costs paid from
fees 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 appropria-
tion account of the Food and Drug Administration
as provided in paragraph (1), and shall be sub-
tracted from the amount of fees that would other-
wise be authorized to be collected under this section
pursuant to appropriation Acts for a subsequent fis-
cal year.
‘‘(h) COLLECTION OF UNPAID FEES.—In any case
where the Secretary does not receive payment of a fee as-
sessed under subsection (a) within 30 days after it is due,
such fee shall be treated as a claim of the United States
Government subject to subchapter II of chapter 37 of title
31, United States Code.
‘‘(i) WRITTEN REQUESTS FOR REFUNDS.—To qual-
ify for consideration for a refund under subsection
(a)(1)(D), a person shall submit to the Secretary a written
request for such refund not later than 180 days after such
fee is due.
‘‘(j) CONSTRUCTION.—This section may not be con-
strued to require that the number of full-time equivalent
positions in the Department of Health and Human Serv-
ices, for officers, employees, and advisory committees not
engaged in the process of the review of device applications,
be reduced to offset the number of officers, employees, and
advisory committees so engaged.’’.
(b) FEE EXEMPTION FOR CERTAIN ENTITIES SUB-
MITTING PREMARKET REPORTS.—
(1) IN GENERAL.—A person submitting a pre-
market report to the Secretary of Health and
Human Services is exempt from the fee under sec-
tion 738(a)(1)(A)(ii) of the Federal Food, Drug, and
Cosmetic Act (as added by subsection (a) of this sec-
tion) if—
(A) the premarket report is the first such
report submitted to the Secretary by the per-
son; and
(B) before October 1, 2002, the person
submitted a premarket application to the Sec-
retary for the same device as the device for
which the person is submitting the premarket
report.
(2) DEFINITIONS.—For purposes of paragraph
(1), the terms ‘‘device’’, ‘‘premarket application’’,
and ‘‘premarket report’’ have the same meanings as
apply to such terms for purposes of section 738 of
the 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 Com-
mittee on Health, Education, Labor and Pensions of the
Senate a report concerning—
(1) the progress of the Food and Drug Admin-
istration in achieving the goals identified in the let-
ters described in section 101(3) during such fiscal
year and the future plans of the Food and Drug Ad-
ministration for meeting the goals, not later than 60
days after the end of each fiscal year during which
fees are collected under this part; and
(2) the implementation of the authority for
such fees during such fiscal year, and the use, by
the Food and Drug Administration, of the fees col-
lected during such fiscal year, not later than 120
days after the end of each fiscal year during which
fees are collected under the medical device user-fee
program established under the amendment made by
section 102.
SEC. 104. POSTMARKET SURVEILLANCE.
(a) ADDITIONAL AUTHORIZATION
OF APPROPRIA-
TIONS.—For the purpose of carrying out postmarket sur-
veillance of medical devices, there are authorized to be ap-
propriated to the Food and Drug Administration the fol-
lowing amounts, stated as increases above the amount ob-
ligated 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 nec-
essary.
(b) STUDY.—
(1) IN GENERAL.—The Secretary of Health and
Human Services (referred to in this section as the
‘‘Secretary’’) shall conduct a study for the purpose
of determining the following with respect to the
medical device user-fee program established under
the 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 de-
vices.
(B) The programmatic improvements, if
any, needed for adequate postmarket surveil-
lance of medical devices.
(C) The amount of funds needed to con-
duct adequate postmarket surveillance of med-
ical devices.
(D) The extent to which device companies
comply with the postmarket surveillance re-
quirements, including postmarket study com-
mitments.
(E) The recommendations of the Secretary
as to whether, and in what amounts, user fees
collected under such user-fee program should be
dedicated to postmarket surveillance if the pro-
gram is extended beyond fiscal year 2007.
(2) REPORT.—Not later than January 10,
2007, the Secretary shall submit to the Committee
on Energy and Commerce of the House of Rep-
resentatives, and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate, a report
that describes the findings of the study under para-
graph (1).
SEC. 105. CONSULTATION.
(a) IN GENERAL.—In developing recommendations to
the Congress for the goals and plans for meeting the goals
for the process for the review of medical device applica-
tions 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 Commerce of the House of Representatives, the Com-
mittee 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 pub-
lish in the Federal Register recommendations under sub-
section (a), after negotiations with the regulated industry;
shall present such recommendations to the congressional
committees specified in such paragraph; shall hold a meet-
ing at which the public may present its views on such rec-
ommendations; and shall provide for a period of 30 days
for the public to provide written comments on such rec-
ommendations.
SEC. 106. EFFECTIVE DATE.
The amendments made by this title shall take effect
on the date of the enactment of this Act, except that fees
shall be assessed for all premarket applications, premarket
reports, supplements, and premarket notification submis-
sions received on or after October 1, 2002, regardless of
the date of enactment.
SEC. 107. SUNSET CLAUSE.
The amendments made by this title cease to be effec-
tive October 1, 2007, except that section 103 with respect
to annual reports ceases to be effective January 31, 2008.
TITLE 
II—AMENDMENTS 
RE-
GARDING 
REGULATION 
OF
MEDICAL DEVICES
SEC. 201. INSPECTIONS BY ACCREDITED PERSONS.
(a) IN GENERAL.—Section 704 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 374) is amended by
adding at the end the following subsection:
‘‘(g)(1) Not later than one year after the date of the
enactment of this subsection, the Secretary shall, subject
to the provisions of this subsection, accredit persons who
are not Federal employees for the purpose of conducting
the inspections required in section 510(h), or pursuant to
section 510(i), for establishments that manufacture, pre-
pare, propagate, compound, or process class II or class
III devices. The owner or operator of such an establish-
ment 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 enact-
ment of this subsection, the Secretary shall publish in the
Federal Register criteria to accredit or deny accreditation
to persons who request to perform the duties specified in
paragraph (1). Thereafter, the Secretary shall inform
those requesting accreditation, within 60 days after the
receipt of such request, whether the request for accredita-
tion is adequate for review, and the Secretary shall
promptly act on the request for accreditation. Any result-
ing accreditation shall state that such person is accredited
to conduct inspections at 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 ac-
credit or deny accreditation to persons who request to per-
form the duties specified in paragraph (1), the Secretary
shall accredit no more than 15 persons who request to per-
form duties specified in paragraph (1).
‘‘(3) An accredited person shall, at a minimum, meet
the following requirements:
‘‘(A) Such person shall be an independent orga-
nization which is not owned or controlled by a man-
ufacturer, supplier, or vendor of articles regulated
under this Act and which has no organizational, ma-
terial, or financial affiliation (including a consult-
ative affiliation) with such a manufacturer, supplier,
or vendor.
‘‘(B) Such person shall be a legally constituted
entity permitted to conduct the activities for which
it seeks accreditation.
‘‘(C) Such person shall not engage in the de-
sign, manufacture, promotion, or sale of articles reg-
ulated under this Act.
‘‘(D) The operations of such person shall be in
accordance with generally accepted professional and
ethical business practices, and such person shall
agree in writing that at a minimum the person
will—
‘‘(i) certify that reported information accu-
rately reflects data reviewed;
‘‘(ii) limit work to that for which com-
petence and capacity are available;
‘‘(iii) treat information received, records,
reports, and recommendations as confidential
commercial or financial information or trade se-
cret information;
‘‘(iv) promptly respond and attempt to re-
solve complaints regarding its activities for
which it is accredited; and
‘‘(v) protect against the use, in carrying
out paragraph (1), of any officer or employee of
the accredited person who has a financial con-
flict of interest regarding any product regulated
under this Act, and annually make available to
the public disclosures of the extent to which the
accredited person, and the officers and employ-
ees 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 accredited
persons to conduct inspections under paragraph (1). Such
list shall be periodically updated to ensure that the iden-
tity of each accredited person 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 withdrawal of accreditation.
‘‘(5)(A) To ensure that persons accredited under this
subsection continue to meet the standards of accredita-
tion, the Secretary shall audit the performance of such
persons on a periodic basis through the review of inspec-
tion reports and inspections by persons designated by the
Secretary to evaluate the compliance status of an estab-
lishment and the performance of accredited persons.
‘‘(B) The Secretary may withdraw accreditation of
any person accredited under paragraph (2), after pro-
viding notice and an opportunity for an informal hearing,
when such person is substantially not in compliance with
the standards of accreditation or poses a threat to public
health or fails to act in a manner that is consistent with
the purposes of this subsection. The Secretary may sus-
pend the accreditation of such person during the pendency
of the process under the preceding sentence.
‘‘(6)(A) Subject to subparagraphs (B) through (C),
a device establishment is eligible for inspections by persons
accredited under paragraph (2) if—
‘‘(i) the Secretary classified the results of the
most recent inspection of the establishment pursuant
to subsection (h) or (i) of section 510 as ‘no action
indicated’ or ‘voluntary action indicated’; and
‘‘(ii) with respect to each inspection to be con-
ducted by an accredited person—
‘‘(I) the owner or operator of the establish-
ment submits to the Secretary a notice request-
ing clearance to use such a person to conduct
the inspection, and the Secretary provides such
clearance; and
‘‘(II) such notice identifies the accredited
person whom the establishment has selected to
conduct the inspection, and the Secretary
agrees to the selected accredited person.
‘‘(B)(i) The Secretary shall respond to a notice under
subparagraph (A) from an establishment not later than
30 days after the Secretary receives the notice. Through
such response, the Secretary shall (I) provide clearance
under such subparagraph, and agree to the selection of
an 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 Sec-
retary for such selection.
‘‘(ii) The request referred to in clause (i)(II) is—
‘‘(I) a request to the establishment involved to
submit to the Secretary compliance data in accord-
ance with clause (iii); or
‘‘(II) a request to the establishment, or to the
accredited person identified in the notice under sub-
paragraph (A), for information concerning the rela-
tionship between the establishment and such accred-
ited person.
The Secretary may make both such requests.
‘‘(iii) The compliance data to be submitted by an es-
tablishment under clause (ii) are data describing whether
the quality controls of the establishment have been suffi-
cient for ensuring consistent compliance with current good
manufacturing practice within the meaning of section
501(h), and data otherwise describing whether the estab-
lishment 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 re-
garding good manufacturing practice or other quality con-
trol audits that, during the preceding two-year period,
were conducted at the establishment by persons other than
the owner or operator of the establishment, together with
all other data the Secretary deems necessary. Data under
the preceding sentence shall demonstrate to the Secretary
whether the establishment has facilitated consistent com-
pliance by promptly correcting any compliance problems
identified in such inspections.
‘‘(iv) Not later than 60 days after receiving compli-
ance data under clause (iii) from an establishment, the
Secretary shall provide or deny clearance under subpara-
graph (A). The Secretary may not deny clearance unless
the Secretary provides to the establishment detailed find-
ings that the establishment has failed to demonstrate con-
sistent compliance for purposes of clause (iii). If the Sec-
retary fails to provide such findings 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 es-
tablishment involved. The Secretary may not reject the se-
lection unless the Secretary provides to the establishment
the reasons for such rejection. Reasons for the rejection
may include that the establishment or the accredited per-
son, as the case may be, has failed to fully respond to
the request. If within such 60-day period the Secretary
fails to agree to or reject the selection in accordance with
this subclause, the Secretary is deemed to have agreed to
the selection.
‘‘(II) If the Secretary rejects the selection of an ac-
credited person by an establishment, the establishment
may make an additional selection of an accredited person
by submitting to the Secretary a notice that identifies the
additional selection. Clauses (i) and (ii), and subclause (I)
of this clause, apply to the selection of an accredited per-
son through a notice under the preceding sentence in the
same manner and to the same extent as such provisions
apply to a selection of an accredited person through a no-
tice under subparagraph (A).
‘‘(vi) In the case of an establishment that under
clause (iv) is denied clearance under subparagraph (A),
or whose selection of an accredited person is rejected
under clause (v), the Secretary shall designate a person
to review the findings of the Secretary under such clause
if, during the 30-day period beginning on the date on
which the establishment receives the findings, the estab-
lishment 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 re-
cent inspection of the establishment by a person accredited
under paragraph (2) as ‘official action indicated’, the es-
tablishment is eligible for further inspections by persons
accredited under such paragraph if (I) the Secretary
issues a written statement to the owner or operator of the
establishment that the violations leading to such classifica-
tion 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 estab-
lishment 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 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 a detailed reason for such denial
within 60 days after the denial. If, as of the expiration
of 48 months after the receipt of the first petition, the
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 appli-
cable, 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 de-
vice establishment’s designated representative and discuss
each observation. Additionally, such accredited person
shall prepare an inspection report (including for inspec-
tions classified as ‘no action indicated’) in a form and
manner consistent with such reports prepared by employ-
ees and officials designated by the Secretary to conduct
inspections.
‘‘(B) At a minimum, an inspection report under sub-
paragraph (A) shall identify the persons responsible for
good manufacturing practice compliance at the inspected
establishment involved, the dates of the inspection, the
scope of the inspection, and shall discuss in detail each
observation identified by the accredited person, identify
other matters that relate to or may influence compliance
with this Act, and discuss any recommendations during
the inspection or at the inspection’s closing meeting.
‘‘(C) An inspection report under subparagraph (A)
shall be sent to the Secretary and the designated rep-
resentative of the inspected establishment involved at the
same time, but under no circumstances later than three
weeks after the last day of the inspection. The report to
the Secretary shall be accompanied by all written inspec-
tion observations previously provided to the representative
of the establishment.
‘‘(D) Any statements or representations made by em-
ployees or agents of a device establishment to persons ac-
credited under paragraph (2) to conduct inspections shall
be subject to section 1001 of title 18, United States Code.
‘‘(E) If at any time during an inspection by an ac-
credited person the accredited person discovers a condition
that could cause or contribute to an unreasonable risk to
the public health, the accredited person shall immediately
notify the Secretary of the identification of the facility
subject to inspection and the conditions of concern.
‘‘(8) Compensation for an accredited person shall be
determined by agreement between the accredited person
and the person who engages the services of the accredited
person, and shall be paid by the person who engages such
services.
‘‘(9) Nothing in this subsection affects the authority
of the Secretary to inspect establishments pursuant to this
Act.
‘‘(10)(A) For fiscal year 2005 and subsequent fiscal
years, no device establishment may be inspected during
the fiscal year involved by a person accredited under para-
graph (2) if—
‘‘(i) of the amounts appropriated for salaries
and expenses of the Food and Drug Administration
for the preceding fiscal year (referred to in this sub-
paragraph as the ‘first prior fiscal year’), the
amount obligated by the Secretary for inspections of
device 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 preceding the first prior fiscal
year (referred to in this subparagraph as the ‘second
prior fiscal year’), the amount obligated by the Sec-
retary 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 Gen-
eral 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 Administra-
tion with respect to devices (referred to in this subpara-
graph as the ‘compliance budget’), and of such amount,
the amount that was obligated for inspections by the Sec-
retary of device establishments (referred to in this sub-
paragraph as the ‘inspection budget’).
‘‘(ii) For purposes of determinations under clause (i),
the Comptroller General shall not include in the compli-
ance budget or the inspection budget any amounts obli-
gated for inspections of device establishments conducted
as part of the process of reviewing applications under sec-
tion 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 Con-
gress a reporting describing the findings made through
such determinations.
‘‘(C) For purposes of this paragraph:
‘‘(i) The term ‘base amount’ means the inspec-
tion budget determined under subparagraph (B) for
fiscal year 2002.
‘‘(ii) The term ‘adjusted base amount’, in the
case of applicability to fiscal year 2003, means an
amount equal to the base amount increased by 5
percent.
‘‘(iii) The term ‘adjusted base amount’, with re-
spect to applicability to fiscal year 2004 or any sub-
sequent fiscal year, means the adjusted based
amount applicable to the preceding year increased by
5 percent.
‘‘(11) The authority provided by this subsection ter-
minates on October 1, 2012.
‘‘(12) No later than four years after the enactment
of this subsection the Comptroller General shall report to
the Committee on Energy and Commerce of the House
of Representatives and the Committee on Health, Edu-
cation, Labor and Pensions of the Senate—
‘‘(A) the number of inspections conducted by
accredited persons and the number of inspections
pursuant to subsections (h) and (i) of section 510
conducted by Federal employees;
‘‘(B) the number of persons who sought accred-
itation under this subsection, as well as the number
of persons who were accredited under this sub-
section;
‘‘(C) the reasons why persons who sought ac-
creditation, but were denied accreditation, were de-
nied;
‘‘(D) the number of audits conducted by the
Secretary of accredited persons, the quality of in-
spections 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 establish-
ment compliance is being presented to the Secretary,
and whether that information is of a quality con-
sistent with information obtained by the Secretary
pursuant to subsection (h) or (i) of section 510;
‘‘(F) whether this subsection is advancing ef-
forts 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 sub-
section.
‘‘(13) The Secretary shall include in the annual re-
port required under section 903(g) the names of all ac-
credited persons and the particular activities under this
subsection for which each such person is accredited and
the name of each accredited person whose accreditation
has been withdrawn during the year.’’.
(b) MAINTENANCE OF RECORDS.—Section 704(f) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
374(f)) is amended—
(1) in paragraph (1), in the first sentence, by
striking ‘‘A person accredited’’ and all that follows
through ‘‘shall maintain records’’ and inserting the
following: ‘‘An accredited person described in para-
graph (3) shall maintain records’’;
(2) in paragraph (2), by striking ‘‘a person ac-
credited under section 523’’ and inserting ‘‘an ac-
credited person described in paragraph (3)’’; and
(3) by adding at the end the following para-
graph:
‘‘(3) For purposes of paragraphs (1) and (2), an ac-
credited person described in this paragraph is a person
who—
‘‘(A) is accredited under subsection (g); or
‘‘(B) is accredited under section 523.’’.
(c) CONFORMING AMENDMENT.—Section 510(h) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360(h)) is amended by inserting after ‘‘duly designated
by the Secretary’’ the following: ‘‘, or by persons accred-
ited to conduct inspections under section 704(g),’’.
SEC. 202. THIRD PARTY REVIEW OF PREMARKET NOTIFICA-
TION.
Section 523 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360m) is amended—
(1) in subsection (c), by striking ‘‘The author-
ity’’ and all that follows and inserting the following:
‘‘The authority provided by this section terminates
October 1, 2007.’’; and
(2) by adding at the end the following sub-
section:
‘‘(d) REPORT.—Not later than January 10, 2007, the
Secretary shall conduct a study based on the experience
under the program under this section and submit to the
Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate, a report de-
scribing 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 Sec-
retary;
‘‘(3) the number of devices reviewed under this
section that were ultimately not cleared by the Sec-
retary;
‘‘(4) the average time period for a review under
this section (including the time it takes for the Sec-
retary to review a recommendation of an accredited
person under subsection (a) and determine the ini-
tial device classification);
‘‘(5) the average time period identified in para-
graph (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 pe-
riod under paragraph (5), the reasons for such dif-
ference;
‘‘(7) whether the quality of reviews under this
section for devices for which no guidance has been
issued is qualitatively inferior to reviews by the Sec-
retary for devices for which no guidance has been
issued;
‘‘(8) whether the quality of reviews under this
section of devices for which no guidance has been
issued is qualitatively inferior to reviews under this
section of devices for which guidance has been
issued;
‘‘(9) whether this section has in any way jeop-
ardized or improved the public health;
‘‘(10) any impact of this section on resources
available to the Secretary to review reports under
section 510(k); and
‘‘(11) any suggestions for continuation, modi-
fication (including expansion of device eligibility), or
termination of this section that the Secretary deter-
mines to be appropriate.’’.
SEC. 203. DESIGNATION AND REGULATION OF COMBINA-
TION PRODUCTS.
Section 503(g) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 353(g)) is amended—
(1) in paragraph (1) -
(A) in the first sentence, by striking ‘‘shall
designate a component of the Food and Drug
Administration’’ and inserting ‘‘shall in accord-
ance with this subsection assign an agency cen-
ter’’; and
(B) in each of subparagraphs (A) through
(C), by striking ‘‘the persons charged’’ and in-
serting ‘‘the agency center charged’’;
(2) by redesignating paragraph (4) as para-
graph (5);
(3) by inserting after paragraph (3) the fol-
lowing paragraph:
‘‘(4)(A) Not later than 60 days after the date of the
enactment of this paragraph, the Secretary shall establish
within the Office of the Commissioner of Food and Drugs
an office to ensure the prompt assignment of combination
products to agency centers, the timely premarket review
of such products, and consistent and appropriate
postmarket regulation of like products subject to the same
statutory requirements to the extent permitted by law. Ad-
ditionally, the office shall, in determining whether a prod-
uct 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 determina-
tions. Such office (referred to in this paragraph as the
‘Office’) shall have appropriate scientific and medical ex-
pertise, and shall be headed by a director.
‘‘(B) In carrying out this subsection, the Office shall,
for each combination product, promptly assign an agency
center with primary jurisdiction in accordance with para-
graph (1) for the premarket review of such product.
‘‘(C) In carrying out this subsection, the Office shall
ensure timely and effective premarket reviews by over-
seeing and coordinating reviews involving more than one
agency center.
‘‘(D) In carrying out this subsection, the Office shall
ensure the consistency and appropriateness of postmarket
regulation of like products subject to the same statutory
requirements to the extent permitted by law. Nothing in
this paragraph shall be construed to limit the postmarket
regulatory authority of any agency center.
‘‘(E) In order to ensure the timeliness of the pre-
market review of a combination product, the agency center
with primary jurisdiction for the product, and the con-
sulting agency center, shall be responsible to the Office
with respect to the timeliness of the premarket review.
‘‘(F)(i) Any dispute regarding the timeliness of the
premarket review of a combination product may be pre-
sented to the Office for resolution, unless the timeliness
of the dispute is clearly premature.
‘‘(ii) During the review process, any dispute regard-
ing the substance of the premarket review may be pre-
sented to the Commissioner of Food and Drugs after first
being considered by the agency center with primary juris-
diction of the premarket review, under the scientific dis-
pute resolution procedures for such center. The Commis-
sioner of Food and Drugs shall consult with the Director
of the Office in resolving the substantive dispute.
‘‘(G) The Secretary, acting through the Office, shall
review each agreement, guidance, or practice of the Sec-
retary that is specific 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 re-
view, the Secretary shall consult with stakeholders and the
directors of the agency centers. After such consultation,
the Secretary shall determine whether to continue in ef-
fect, modify, revise, or eliminate such agreement, guid-
ance, 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 para-
graph shall be construed as preventing the Secretary from
following each agreement, guidance, or practice until con-
tinued, modified, revised, or eliminated.
‘‘(H) 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 com-
bination products under review and the timeliness in
days of such assignments, reviews, and dispute reso-
lutions;
‘‘(ii) identifying the number of premarket re-
views of such products that involved a consulting
agency center; and
‘‘(iii) describing improvements in the consist-
ency of postmarket regulation of combination prod-
ucts.’’; and
(4) in paragraph (5) (as redesignated by para-
graph (2) of this section)—
(A) by redesignating subparagraphs (A)
and (B) as subparagraphs (B) and (C), respec-
tively; and
(B) by inserting before subparagraph (B)
the following subparagraph:
‘‘(A) The term ‘agency center’ means a center
or alternative organizational component of the Food
and Drug Administration.’’.
SEC. 204. REPORT ON CERTAIN DEVICES.
Not later than one year after the date of enactment
of this Act, the Secretary of Health and Human Services
shall report to the appropriate committees of Congress on
the timeliness and effectiveness of device premarket re-
views 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 submis-
sions and supplements, times required to review manufac-
turers’ replies to submissions, and times to approve or
clear such devices. Such report shall contain the Sec-
retary’s recommendations on any measures needed to im-
prove performance including, but not limited to, the alloca-
tion of additional resources. Such report also shall include
the Secretary’s specific recommendation on whether re-
sponsibility for regulating such devices should be reas-
signed to those persons within the Food and Drug Admin-
istration who are primarily charged with regulating other
types of devices, and whether such a transfer could have
a deleterious impact on the public health and on the safety
of such devices.
SEC. 205. ELECTRONIC LABELING.
Section 502(f) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 352(f)) is amended by adding at the
end the following: ‘‘Required labeling for prescription de-
vices intended for use in health care facilities may be made
available solely by electronic means provided that the la-
beling 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 facil-
ity the requested information without additional cost.’’.
SEC. 206. ELECTRONIC REGISTRATION.
Section 510 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360) is amended by adding at the end the
following:
‘‘(p) Registrations under subsections (b), (c), (d), and
(i) (including the submission of updated information) shall
be submitted to the Secretary by electronic means, upon
a finding by the Secretary that the electronic receipt of
such registrations is feasible, unless the Secretary grants
a request for waiver of such requirement because use of
electronic means is not reasonable for the person request-
ing such waiver.’’.
SEC. 207. INTENDED USE.
Section 513(i)(1)(E) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360c(i)(1)(E)) is amended by
striking clause (iv).
SEC. 208. MODULAR REVIEW.
Section 515(c) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360e(c)) is amended by adding at
the end the following:
‘‘(3)(A) Prior to the submission of an application
under this subsection, the Secretary shall accept and re-
view portions of such applications that applicants and the
Secretary agree are complete, ready, and appropriate for
review.
‘‘(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 requirements of paragraph (1), unless
issues of safety or effectiveness provide the Secretary
cause to review such accepted portion.
‘‘(C) Whenever the Secretary determines that a por-
tion of a submission under subparagraph (A) is unaccept-
able, the Secretary shall specifically identify, in writing,
the deficiency of such portion and describe in detail the
means by which it may be made acceptable, unless the
sponsor is no longer pursuing the application.’’.
SEC. 209. PEDIATRIC EXPERTISE REGARDING CLASSIFICA-
TION-PANEL REVIEW OF PREMARKET APPLI-
CATIONS.
Section 515(c)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360e(c)(2)) is amended by add-
ing at the end the following: ‘‘If the Secretary determines
that there is a reasonable likelihood that the device in-
volved will be used in a pediatric population, the Secretary
shall ensure that such panel includes, or consults with, one
or more pediatric experts.’’.
SEC. 210. INTERNET LIST OF CLASS II DEVICES EXEMPTED
FROM REQUIREMENT OF PREMARKET NOTI-
FICATION.
Section 510(m)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(m)(1)) is amended by add-
ing at the end the following: ‘‘The Secretary shall publish
such list on the Internet site of the Food and Drug Ad-
ministration. The list so published shall be updated not
later than 30 days after each revision of the list by the
Secretary.’’.
SEC. 
211. 
STUDY 
BY 
INSTITUTE 
OF 
MEDICINE 
OF
POSTMARKET 
SURVEILLANCE 
REGARDING
PEDIATRIC POPULATIONS.
(a) IN GENERAL.—The Secretary of Health and
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall request the Institute of Medicine to enter
into an agreement with the Secretary under which such
Institute conducts a study for the purpose of determining
whether the system under the Federal Food, Drug, and
Cosmetic Act for the postmarket surveillance of medical
devices provides adequate safeguards regarding the use of
devices in pediatric populations.
(b) CERTAIN MATTERS.—The Secretary shall ensure
that determinations made in the study under subsection
(a) include determinations of—
(1) whether postmarket surveillance studies of
implanted medical devices are of long enough dura-
tion to evaluate the impact of growth and develop-
ment for the number of years that the child will
have the implant, and whether the studies are ade-
quate to evaluate how children’s active lifestyles may
affect the failure rate and longevity of the implant;
and
(2) whether the amount of funds allocated for
postmarket surveillance by the Food and Drug Ad-
ministration of medical devices used in pediatric
populations is sufficient to provide adequate safe-
guards 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 en-
sure that, not later than four years after the date of the
enactment of this Act, a report describing the findings of
the study under subsection (a) is submitted to the Con-
gress. 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. 212. GUIDANCE REGARDING PEDIATRIC DEVICES.
Section 520 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360j) is amended by adding at the end
the following subsection:
‘‘Guidance Regarding Pediatric Devices
‘‘(n) Not later than 270 days after the date of the
enactment of the Medical Device User Fee and Moderniza-
tion Act of 2002, the Secretary shall issue guidance on
the following:
‘‘(1) The type of information necessary to pro-
vide reasonable assurance of the safety and effective-
ness of devices intended for use in pediatric popu-
lations.
‘‘(2) Protections for pediatric subjects in clin-
ical investigations of the safety or effectiveness of
such devices.’’.
SEC. 213. BREAST IMPLANTS; STUDY BY COMPTROLLER
GENERAL.
(a) IN GENERAL.—The Comptroller General of the
United States shall conduct a study to determine the fol-
lowing with respect to breast implants:
(1) The content of information typically pro-
vided by health professionals to women who consult
with such professionals on the issue of whether to
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.
(3) Whether the information provided presents
a fair and balanced statement of the risks and bene-
fits of receiving the implants (taking into account
the frequency of updates to the information), and if
so, at what point in the process of determining
whether to undergo surgery is such information pro-
vided.
(4) Whether women understand the information
that is provided (including full appreciation of the
risks), and whether and to what extent the informa-
tion influences the decision to receive the implants.
(5) The number of adverse events that have
been reported, and whether such events have been
adequately investigated.
(6) With respect to women who participate as
subjects in research being carried out regarding the
safety and effectiveness of breast implants:
(A) The content of information provided to
the women during the process of obtaining the
informed consent of the women to be subjects,
and whether such information is appropriately
updated.
(B) Whether such process provides written
explanations of the criteria for being subjects in
the research.
(C) The point at which, in the planning or
conduct of the research, the women are pro-
vided information regarding the provision of in-
formed consent to be subjects.
(D) Whether, before providing informed
consent, the women fully appreciate the risks of
being subjects in the research.
(b) REPORT.—The Comptroller General shall submit
to the Congress a report describing the findings of the
study.
(c) DEFINITION.—For purposes of this section, the
term ‘‘breast implant’’ means a breast prosthesis that is
implanted to augment or reconstruct the female breast.
SEC. 214. BREAST IMPLANTS; RESEARCH THROUGH NA-
TIONAL INSTITUTES OF HEALTH.
(a) REPORT ON STATUS OF CURRENT RESEARCH.—
Not later than 180 days after the date of the enactment
of this Act, the Director of the National Institutes of
Health shall submit to the Congress a report describing
the status of research on breast implants (as defined in
section 213(c)) being conducted or supported by such In-
stitutes.
(b) RESEARCH
ON LONG-TERM IMPLICATIONS.—
Part H of title IV of the Public Health Service Act (42
U.S.C. 289 et seq.) is amended by adding at the end of
the following section:
‘‘SEC. 498C. BREAST IMPLANT RESEARCH.
‘‘(a) IN GENERAL.—The Director of NIH shall con-
duct or support prospective or retrospective research to
examine the long-term health implications of both saline
and silicone breast implants. If scientifically appropriate,
such research studies may include the following:
‘‘(1) A multidisciplinary study of women who
have received silicone and saline implants and have
had an implant for a sufficient amount of time to
allow for appropriate comparison as to the long-term
health consequences.
‘‘(2) A comparison of women receiving implants
for reconstruction after mastectomy to breast cancer
patients who have not had reconstruction, including
subsets of women with saline implants and women
with silicone implants.
‘‘(b) DEFINITION.—For purposes of this section, the
term ‘breast implant’ means a breast prosthesis that is
implanted to augment or reconstruct the female breast.’’.
TITLE III—ADDITIONAL
AMENDMENTS
SEC. 301. IDENTIFICATION OF MANUFACTURER OF MED-
ICAL DEVICES.
(a) IN GENERAL.—Section 502 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 352) is amended by
adding at the end the following:
‘‘(u) If it is a device, unless it, or an attachment
thereto, prominently and conspicuously bears the name of
the manufacturer of the device, a generally recognized ab-
breviation of such name, or a unique and generally recog-
nized symbol identifying such manufacturer, except that
the Secretary may waive any requirement under this para-
graph for the device if the Secretary determines that com-
pliance with the requirement is not feasible for the device
or would compromise the provision of reasonable assur-
ance of the safety or effectiveness of the device.’’.
(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 in-
troduced or delivered for introduction into interstate com-
merce after such effective date.
SEC. 302. SINGLE-USE MEDICAL DEVICES.
(a) REQUIRED STATEMENTS ON LABELING.—
(1) IN GENERAL.—Section 502 of the Federal
Food, Drug, and Cosmetic Act, as amended by sec-
tion 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. Re-
processed by ll.’ The name of the manufacturer of the
reprocessed device shall be placed in the space identifying
the person responsible for reprocessing.’’.
(2) EFFECTIVE DATE.—The amendment made
by paragraph (1) takes effect 15 months after the
date of the enactment of this Act, and only applies
to devices introduced or delivered for introduction
into interstate commerce after such effective date.
(b) PREMARKET NOTIFICATION.—Section 510 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360)
is amended by inserting after subsection (n) the following:
‘‘(o)(1) With respect to reprocessed single-use devices
for which reports are required under subsection (k):
‘‘(A) The Secretary shall identify such devices
or types of devices for which reports under such sub-
section must, in order to ensure that the device is
substantially equivalent to a predicate device, include
validation data, the types of which shall be specified
by the Secretary, regarding cleaning and steriliza-
tion, and functional performance demonstrating that
the single-use device will remain substantially equiv-
alent to its predicate device after the maximum
number of times the device is reprocessed as in-
tended by the person submitting the premarket noti-
fication. Within one year after enactment of this
subsection, the Secretary shall publish in the Fed-
eral Register a list of the types 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 sub-
section (k) that was submitted to the Secretary be-
fore the publication of the initial list under subpara-
graph (A), or any revision thereof, and was for a de-
vice or type of device included on such list, the per-
son who submitted the report under subsection (k)
shall submit validation data as described in subpara-
graph (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 sub-
mission of the validation data to the Secretary, the
Secretary may not determine that the device is mis-
branded under section 502(o), adulterated under
section 501(f)(1)(B), or take action against the de-
vice under section 301(p) for failure to provide any
information required by subsection (k) until (i) the
review is terminated by withdrawal of the submis-
sion of the report under subsection (k); (ii) the Sec-
retary finds the data to be acceptable and issues a
letter; or (iii) the Secretary determines that the de-
vice is not substantially equivalent to a predicate de-
vice. Upon a determination that a device is not sub-
stantially equivalent to a predicate device, or if such
submission is withdrawn, the device can no longer be
legally marketed.
‘‘(C) In the case of a report under subsection
(k) for a device identified under subparagraph (A)
that is of a type for which the Secretary has not
previously received a report under such subsection,
the Secretary may, in advance of revising the list
under subparagraph (A) to include such type, re-
quire 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 semicritical reproc-
essed single-use devices that, under subsection (l) 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 as-
surance of the safety and effectiveness of the de-
vices. 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 terminated 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 paragraph
(1)(A).
‘‘(B) For each device or type of device included
on the list under subparagraph (A), a report under
subsection (k) shall be submitted to the Secretary
not later than 15 months after the publication of the
initial list, or a revision of the list, whichever termi-
nates 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), adulter-
ated under section 501(f)(1)(B), or take action
against the device under section 301(p) for failure to
provide any information required by subsection (k)
until (i) the review is terminated by withdrawal of
the submission; (ii) the Secretary determines by
order that the device is substantially equivalent to a
predicate device; or (iii) the Secretary determines by
order that the device is not substantially equivalent
to a predicate device. Upon a determination that a
device is not substantially equivalent to a predicate
device, the device can no longer be legally marketed.
‘‘(C) The initial list under subparagraph (A)
shall be published not later than 18 months after
the effective date of this subsection.
‘‘(D) Section 502(o) applies with respect to the
failure to submit a report under subsection (k) that
is required pursuant to subparagraph (A), including
a failure of the report to include validation data re-
quired in such subparagraph.
‘‘(E) The termination under subparagraph (A)
of an exemption under subsection (l) or (m) for a
critical or semicritical reprocessed single-use device
does not terminate the exemption under subsection
(l) or (m) for the original device.
‘‘(3) In the case of a reprocessed single-use device
that is classified in class III and for which a premarket
application is required, the following provisions apply with
respect to such reprocessed device in lieu of an application
for premarket approval under section 515:
‘‘(A) The device shall not be introduced into
interstate commerce or delivered for introduction
into interstate commerce unless the person involved
has submitted to the Secretary a report in accord-
ance with this paragraph and the Secretary, after
reviewing the report, issues an order determining
there is a reasonable assurance of the safety and ef-
fectiveness for the device.
‘‘(B) The report under subparagraph (A) shall
contain the following:
‘‘(i) The device name, including both the
trade or proprietary name and the common or
usual name.
‘‘(ii) The establishment registration num-
ber of the owner or operator submitting the re-
port.
‘‘(iii) Actions taken to comply with per-
formance standards under section 514.
‘‘(iv) Proposed labels, labeling, and adver-
tising sufficient to describe the device, its in-
tended use, and directions for use.
‘‘(v) Full reports of all information, pub-
lished or known to or which should be reason-
ably known to the applicant, concerning inves-
tigations which have been made to show wheth-
er or not a device is safe or effective.
‘‘(vi) A description of the device’s compo-
nents, ingredients, and properties.
‘‘(vii) A full description of the methods
used in, and the facilities and controls used for,
the reprocessing and packing of the device.
‘‘(viii) Such samples of the device that the
Secretary may reasonably require.
‘‘(ix) A financial certification or disclosure
statement or both, as required by part 54 of
title 21, Code of Federal Regulations.
‘‘(x) A statement that the applicant be-
lieves to the best of the applicant’s knowledge
that all data and information submitted to the
Secretary are truthful and accurate and that no
material fact has been omitted in the report.
‘‘(xi) Any additional data and information
that the Secretary determines is necessary to
determine whether there is reasonable assur-
ance of safety and effectiveness for the reproc-
essed device.
‘‘(C) In addition to the information or data re-
quired in subparagraph (B), the report under sub-
paragraph (A) shall include the validation data de-
scribed in paragraph (1)(A) that demonstrates that
the reasonable assurance of the safety or effective-
ness of the device will remain after the maximum
number of times the device is reprocessed as in-
tended by the person submitting the report under
this paragraph.’’.
(c) DEFINITIONS.—Section 201 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321) is amended by
adding at the end the following:
‘‘(ll)(1) The term ‘single-use device’ means a device
that is intended for one use, or on a single patient during
a single procedure.
‘‘(2)(A) The term ‘reprocessed’, with respect to a sin-
gle-use device, means an original device that has pre-
viously 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 subparagraph (A) shall be considered a reprocessed
device without regard to any description of the device used
by the manufacturer of the device or other persons, includ-
ing a description that uses the term ‘recycled’ rather than
the term ‘reprocessed’.
‘‘(3) The term ‘original device’ means a new, unused
single-use device.
‘‘(mm)(1) The term ‘critical reprocessed single-use
device’ means a reprocessed single-use device that is in-
tended 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 in-
tended to contact intact mucous membranes and not pene-
trate normally sterile areas of the body.’’.
(d) PROHIBITED ACTS.—Section 301 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 331), as
amended by section 321(b)(2) of Public Law 107–188, is
amended by adding at the end the following:
‘‘(gg) The introduction or delivery for introduction
into interstate commerce of any device in violation of sec-
tion 510(o)(3).’’.
Passed the House of Representatives October 9,
2002.
Attest:
Clerk.
107TH CONGRESS
2D SESSION
H. R. 3580
AN ACT
To amend the Federal Food, Drug, and Cosmetic
Act to make improvements in the regulation of
medical devices, and for other purposes.