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
applications.
Sec. 211. Internet list of class II devices exempted from requirement of pre-
market notification.
Sec. 212. Study by Institute of Medicine of postmarket surveillance regarding
pediatric 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.
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 making
additional funds available for the purpose of aug-
menting the resources of the Food and Drug Admin-
istration that are devoted to the process for the re-
view of devices and the assurance of device safety
and effectiveness so that statutorily mandated dead-
lines may be met; and
(3) the fees authorized by this title will be dedi-
cated 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 Sen-
ate, 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 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 515(c)(2).
‘‘(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 or report has been ap-
proved 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 ef-
fective under section 515(f).
‘‘(B) The term ‘panel-track supplement’ means
a supplement 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 the device, and
for which clinical data are generally necessary to
provide a reasonable assurance of safety and effec-
tiveness.
‘‘(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, specifica-
tion, 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 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 1.42 percent of
the fee that applies under clause (i), sub-
ject to any adjustment under subsection
(c)(3) and any adjustment under sub-
section (e)(2)(C)(ii).
‘‘(B) EXCEPTIONS.—
‘‘(i) HUMANITARIAN DEVICE EXEMP-
TION.—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 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, pre-
market report, or premarket notifica-
tion submission if the proposed condi-
tions of use for the device involved are
solely for a pediatric population. No
fee shall be required under such sub-
paragraph for a supplement if the sole
purpose of the supplement is to pro-
pose 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 or premarket re-
port for which, under subclause (I), a
fee under subparagraph (A) is not re-
quired, any supplement to such appli-
cation that proposes conditions of use
for any adult population is subject to
the fee that applies under such sub-
paragraph for a premarket applica-
tion.
‘‘(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-
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), (e), (g), and (h), the fees under
subsection (a) shall be established to generate the fol-
lowing 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 Sec-
retary to fund additional 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 attrib-
utable 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).
‘‘(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 and subsection
(e)(2)(C)(ii), except that the fees established for fis-
cal year 2003 shall be based on a premarket applica-
tion 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 re-
view 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 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
PREMARKET
AP-
PROVAL 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 tax-
able year, including such returns of all of
its affiliates, partners, and parent firms.
‘‘(ii) ADJUSTMENT.—The Secretary
may adjust the $30,000,000 threshold es-
tablished in clause (i) if the Secretary has
evidence from actual experience that this
threshold results in a reduction in revenues
from premarket applications, premarket re-
ports, and supplements 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 a notice in the Federal Reg-
ister setting out the rationale for the ad-
justment, 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, and a copy of such re-
turns of its affiliates, partners, and parent
firms. which show an amount of gross sales or
receipts that is less than the maximum estab-
lished 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 Rev-
enue Service. If no tax forms are submitted for
affiliates, partners, or parent firms, the appli-
cant shall certify that the applicant has no af-
filiates, partners, or parent firms, respectively.
‘‘(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 a reduced rate of 38 percent of the fee estab-
lished under such subsection for a premarket
application, a premarket report, or a supple-
ment.
‘‘(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). The decision of the Secretary re-
garding whether an entity qualifies for such a
waiver or reduction is not reviewable.
‘‘(e) SMALL BUSINESSES; FEE REDUCTION REGARD-
ING PREMARKET NOTIFICATION SUBMISSIONS.—
‘‘(1) IN GENERAL.—Where the Secretary finds
that the applicant involved is a small business, the
fee specified in subsection (a)(1)(A)(vii) may be paid
at a reduced rate in accordance with paragraph
(2)(C).
‘‘(2) RULES RELATING TO PREMARKET NOTIFI-
CATION SUBMISSIONS.—
‘‘(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 Fed-
eral income tax return for a taxable year, in-
cluding such returns of all of its affiliates, part-
ners, 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 submitted for affiliates, partners, or parent
firms, the applicant shall certify that the appli-
cant has no affiliates, partners, or parent firms,
respectively.
‘‘(C) REDUCED FEES.—
‘‘(i) IN
GENERAL.—Where the Sec-
retary 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)(1)(A)(vii), as adjusted under clause (ii)
and as established under subsection (c)(5).
‘‘(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 sub-
missions for the fiscal year involved paid a
fee equal to 1.42 percent of the amount
that applies under subsection (a)(1)(A)(i)
for premarket applications, and shall ad-
just the fee under subsection (a)(1)(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 ap-
plicant seeking a fee reduction under this sub-
section shall submit supporting information to
the Secretary at least 60 days before the fee is
required pursuant to subsection (a). The deci-
sion of the Secretary regarding whether an enti-
ty qualifies for such a reduction is not review-
able.
‘‘(f) 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.
‘‘(g) 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 performance goals
identified for the fiscal year if the total of the
amounts so appropriated for fiscal years 2003
through 2005, excluding the amount of fees ap-
propriated for such fiscal years, is 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.
‘‘(h) 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.
‘‘(i) 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.
‘‘(j) 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.
‘‘(k) 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 for
the purpose of conducting inspections of establishments
that manufacture, prepare, propagate, compound, or proc-
ess 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), se-
lect 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 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 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 may not be an employee of
the Federal Government.
‘‘(B) 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.
‘‘(C) Such person shall be a legally constituted
entity permitted to conduct the activities for which
it seeks accreditation.
‘‘(D) Such person shall not engage in the de-
sign, manufacture, promotion, or sale of articles reg-
ulated under this Act.
‘‘(E) 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, inspection obser-
vations 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 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, except such information may
be made available to the Secretary;
‘‘(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 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 accredita-
tion 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 accredita-
tion, the Secretary shall (i) 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 a device es-
tablishment 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 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) and (C), a de-
vice establishment is eligible for inspections by persons ac-
credited under paragraph (2) if the following conditions
are met:
‘‘(i) The Secretary classified the results of the
most recent inspection of the establishment 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 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.
‘‘(iii) With respect to the devices that are man-
ufactured, 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 mar-
keted, 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.
‘‘(II) The owner or operator of the estab-
lishment submits to the Secretary a statement
that the law of a country in which such a device
is marketed, or is intended to be marketed, rec-
ognizes an inspection of the establishment by
the Secretary, and not later than 30 days after
receiving such statement, the Secretary informs
the owner or operator of the establishment that
the owner or operator may submit a notice re-
questing clearance under clause (ii).
‘‘(iv)(I) In the case of an inspection to be con-
ducted pursuant to 510(h), persons accredited under
paragraph (2) did not conduct the two immediately
preceding inspections of the establishment, 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 inspec-
tion 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 op-
erator 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 waiv-
er that is granted or deemed to be granted, no addi-
tional such waiver may be granted until after the
Secretary has conducted an inspection of the estab-
lishment.
‘‘(II) In the case of an inspection to be con-
ducted pursuant to 510(i), the Secretary periodically
conducts inspections of the establishment.
‘‘(B)(i) The Secretary shall respond to a notice under
subparagraph (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 se-
lection 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 in-
volved 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 sub-
paragraph (A), for information concerning the rela-
tionship between the establishment and such accred-
ited person, including information about the number
of inspections of the establishment, or other estab-
lishments owned or operated by the owner or oper-
ator of the establishment, that have been conducted
by the accredited person.
The Secretary may make both such requests.
‘‘(iii) The compliance data to be submitted by a de-
vice establishment 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 in-
spections 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, to-
gether with all other compliance data the Secretary deems
necessary. Data under the preceding sentence shall dem-
onstrate to the Secretary whether the establishment has
facilitated consistent compliance 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 a device establishment,
the Secretary shall provide or deny clearance under sub-
paragraph (A). The Secretary may deny clearance if the
Secretary determines that the establishment 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 establish-
ment 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 de-
vice establishment involved. The Secretary may reject the
selection if the Secretary provides to the establishment a
statement of the reasons for such rejection. Reasons for
the rejection may include that the establishment or the
accredited person, as the case may be, has failed to fully
respond to the request, or that the Secretary has concerns
regarding the relationship between the establishment and
such accredited person. If within such 60-day period the
Secretary fails to agree to or reject the selection in accord-
ance 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 a device establishment, the establish-
ment may make an additional selection of an accredited
person by submitting to the Secretary a notice that identi-
fies the additional selection. Clauses (i) and (ii), and sub-
clause (I) of this clause, apply to the selection of an ac-
credited person through a notice under the preceding sen-
tence 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 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, if otherwise eligible under subparagraph (A),
is eligible for further inspections by persons accredited
under such paragraph if (I) the Secretary issues a written
statement to the owner or operator of the establishment
that the violations leading to such classification have been
resolved, and (II) the Secretary, either upon the Sec-
retary’s own initiative or a petition of the owner or oper-
ator of the establishment, notifies the establishment that
it has clearance to use an accredited person for the inspec-
tions. 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 expi-
ration of one year after such denial, again petition the Sec-
retary 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 de-
nial 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 de-
scribe each observation. Additionally, such accredited per-
son shall prepare an inspection report (including for in-
spections 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
device establishment, the dates of the inspection, the scope
of the inspection, and shall describe in detail each observa-
tion identified by the accredited person, identify 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 sent to the Secretary and to the designated rep-
resentative 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 inspec-
tion observations previously provided to the designated
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 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 device es-
tablishment 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 pur-
suant to this Act.
‘‘(10)(A) For fiscal year 2005 and each subsequent
fiscal year, no device establishment may be inspected dur-
ing the fiscal year involved by a person accredited under
paragraph (2) if—
‘‘(i) of the amounts appropriated for salaries
and expenses of the Food and Drug Administration
for the preceding fiscal year (referred to in this sub-
paragraph as the ‘first prior fiscal year’), the
amount obligated by the Secretary for inspections of
device 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 pursuant to
subsections (h) and (i) of section 510 conducted by
accredited persons and the number of inspections
pursuant to such subsections 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 device es-
tablishment compliance is being presented to the
Secretary, and whether that information is of a
quality consistent with information obtained by the
Secretary pursuant to subsection (h) or (i) of section
510;
‘‘(F) whether this subsection is advancing 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.
‘‘(14) Notwithstanding any provision of this sub-
section, 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 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) CIVIL 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 fol-
lowing: ‘‘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 ac-
creditation 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 de-
vices.’’.
(d) PROHIBITED ACTS.—Section 301 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following:
‘‘(gg) The knowing failure of a person accredited
under paragraph (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 re-
port under paragraph (7)(A) of such section; or the know-
ing 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 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 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 subsection:
‘‘(m) DEVICES; MANDATORY DEBARMENT REGARD-
ING THIRD-PARTY INSPECTIONS AND REVIEWS.—
‘‘(1) IN GENERAL.—If the Secretary finds that
a person has been convicted of a felony under sec-
tion 301(gg), the Secretary 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 person under paragraph (1) for the fol-
lowing 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 under such
paragraph occurs within 10 years after such
person has been debarred under such para-
graph, the period of debarment shall be perma-
nent.
‘‘(B) The debarment of an individual shall
be permanent.
‘‘(3) TERMINATION OF DEBARMENT; JUDICIAL
REVIEW; OTHER MATTERS.—Subsections (c)(3), (d),
(e), (i), (j), and (l)(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 sub-
section (a)(1), or an individual who is debarred
under subsection (a)(2), respectively.’’.
SEC. 204. 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 and effective pre-
market review of such products, and consistent and appro-
priate postmarket regulation of like products subject 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 prod-
uct, 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 para-
graph 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 primary jurisdiction in accordance with para-
graph (1) for the premarket 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 in-
volving more than one agency center.
‘‘(ii) 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.
‘‘(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 pre-
sented to the Office for resolution, unless 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.
‘‘(F) 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.
‘‘(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 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.
‘‘(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 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. 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 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. 206. 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. 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 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. 208. 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. 209. 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 any portion of the application that the applicant and
the Secretary agree is complete, ready, and appropriate
for review, except that such requirement 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 requirements 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 por-
tion of a submission under subparagraph (A) is unaccept-
able, the Secretary shall, in writing, provide to the appli-
cant 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.’’.
SEC. 210. PEDIATRIC EXPERTISE REGARDING CLASSIFICA-
TION-PANEL REVIEW OF PREMARKET APPLI-
CATIONS.
Section 515(c) of the Federal Food, Drug, and Cos-
metic 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 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. 
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 ‘‘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 postmarket surveillance by the
Food and Drug Administration of medical devices
used in pediatric populations is sufficient to provide
adequate safeguards for such populations, taking
into account the Secretary’s monitoring of commit-
ments made at the time of approval of medical de-
vices, such as phase IV trials, and the Secretary’s
monitoring and use of adverse reaction reports, reg-
istries, 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. 213. GUIDANCE REGARDING PEDIATRIC DEVICES.
Not later than 270 days after the date of the enact-
ment of this Act, the Secretary of Health and Human
Services shall issue guidance on the following:
(1) The type of information necessary to pro-
vide reasonable assurance of the safety and effective-
ness of medical devices intended for use in pediatric
populations.
(2) Protections for pediatric subjects in clinical
investigations of the safety or effectiveness of such
devices.
SEC. 214. 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,
and at what point in the process of determining
whether to undergo surgery is such information pro-
vided.
(3) Whether the information presented, as a
whole, provides a complete and accurate 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 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 the extent to which such information is up-
dated.
(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.
(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. 215. 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 may con-
duct or support research to examine the long-term health
implications of silicone breast implants, both gel and sa-
line filled. Such research studies may include the fol-
lowing:
‘‘(1) Developing and examining techniques to
measure concentrations 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 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 six months 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 semi-critical 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) In the case of semi-critical devices, the ini-
tial 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 pub-
lished 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 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.’’.
(c) PREMARKET REPORT.—Section 515 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360e) is
amended—
(1) in subsection (a), in the matter after and
below paragraph (2), by inserting before the period
the following: ‘‘or, as applicable, an approval under
subsection (c)(2) of a report seeking premarket ap-
proval’’; and
(2) in subsection (c)—
(A) by redesignating paragraph (2) as
paragraph (3); and
(B) by inserting after paragraph (1) the
following paragraph:
‘‘(2)(A) Any person may file with the Secretary a re-
port seeking premarket approval for a class III device re-
ferred 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 proprietary name and the common or usual name.
‘‘(ii) The establishment registration number of
the owner or operator submitting the report.
‘‘(iii) Actions taken to comply with performance
standards under section 514.
‘‘(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, concerning 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 reproc-
essing and packing of the device.
‘‘(viii) Such samples of the device that the Sec-
retary may reasonably require.
‘‘(ix) A financial certification or disclosure
statement or both, as required by part 54 of title 21,
Code of Federal Regulations.
‘‘(x) A statement that the applicant believes to
the best of the applicant’s knowledge that all data
and information submitted to the Secretary are
truthful and accurate and that no material fact has
been omitted in the report.
‘‘(xi) Any additional data and information, in-
cluding information of the type required in para-
graph (1) for an application under such paragraph,
that the Secretary determines is necessary to deter-
mine whether there is reasonable assurance of safety
and effectiveness for the reprocessed device.
‘‘(xii) Validation data described in section
510(o)(1)(A) that demonstrates that the reasonable