PUBLIC LAW 107–250—OCT. 26, 2002

MEDICAL DEVICE USER FEE AND

MODERNIZATION ACT OF 2002

116 STAT. 1588 PUBLIC LAW 107–250—OCT. 26, 2002

Public Law 107–250

107th Congress

An Act

To amend the Federal Food, Drug, and Cosmetic Act to make improvements in

the regulation of medical devices, and for other purposes.

Be it enacted by the Senate and House of Representatives of

the United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) SHORT TITLE.—This Act may be cited as the ‘‘Medical Device

User Fee and Modernization Act of 2002’’.

(b) TABLE OF CONTENTS.—The table of contents for this Act

is as follows:

Sec. 1. Short title; table of contents.

TITLE I—FEES RELATED TO MEDICAL DEVICES

Sec. 101. Findings.

Sec. 102. Establishment of program.

Sec. 103. Annual reports.

Sec. 104. Postmarket surveillance.

Sec. 105. Consultation.

Sec. 106. Effective date.

Sec. 107. Sunset clause.

TITLE II—AMENDMENTS REGARDING REGULATION OF MEDICAL DEVICES

Sec. 201. Inspections by accredited persons.

Sec. 202. Third party review of premarket notification.

Sec. 203. Debarment of accredited persons.

Sec. 204. Designation and regulation of combination products.

Sec. 205. Report on certain devices.

Sec. 206. Electronic labeling.

Sec. 207. Electronic registration.

Sec. 208. Intended use.

Sec. 209. Modular review.

Sec. 210. Pediatric expertise regarding classification-panel review of premarket applications.

Sec. 211. Internet list of class II devices exempted from requirement of premarket

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.

21 USC 301 note.

Medical Device

User Fee and

Modernization

Act of 2002.

Oct. 26, 2002

[H.R. 5651]

PUBLIC LAW 107–250—OCT. 26, 2002 116 STAT. 1589

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 augmenting the resources

of the Food and Drug Administration that are devoted to the

process for the review of devices and the assurance of device

safety and effectiveness so that statutorily mandated deadlines

may be met; and

(3) the fees authorized by this title will be dedicated to

meeting the goals identified in the letters from the Secretary

of Health and Human Services to the Committee on Energy

and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate,

as set forth in the Congressional Record.

SEC. 102. ESTABLISHMENT OF PROGRAM.

(a) IN GENERAL.—Subchapter C of chapter VII of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 379F et seq.) is amended

by adding at the end the following part:

‘‘PART 3—FEES RELATING TO DEVICES

‘‘SEC. 737. DEFINITIONS.

‘‘For purposes of this subchapter: ‘‘(1) The term ‘premarket application’ means— ‘‘(A) an application for approval of a device submitted

under section 515(c) or section 351 of the Public Health

Service Act; or ‘‘(B) a product development protocol described in section 515(f).

Such term does not include a supplement, a premarket report,

or a premarket notification submission.

‘‘(2) The term ‘premarket report’ means a report submitted

under section 515(c)(2).

‘‘(3) The term ‘premarket notification submission’ means

a report submitted under section 510(k).

‘‘(4)(A) The term ‘supplement’, with respect to a paneltrack 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 approved under

section 515(d), or an application has been approved under

section 351 of the Public Health Service Act; or

‘‘(ii) a notice of completion has become effective under

section 515(f).

‘‘(B) The term ‘panel-track supplement’ means a 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

21 USC 379i.

21 USC 379i

note.

116 STAT. 1590 PUBLIC LAW 107–250—OCT. 26, 2002

the device, and for which clinical data are generally necessary

to provide a reasonable assurance of safety and effectiveness.

‘‘(C) The term ‘180-day supplement’ means a supplement

to an approved premarket application or premarket report

under section 515 that is not a panel-track supplement and

requests a significant change in components, materials, design,

specification, software, color additives, or labeling.

‘‘(D) The term ‘real-time supplement’ means a supplement

to an approved premarket application or premarket report

under section 515 that requests a minor change to the device,

such as a minor change to the design of the device, software,

manufacturing, sterilization, or labeling, and for which the

applicant has requested and the agency has granted a meeting

or similar forum to jointly review and determine the status

of the supplement.

‘‘(E) The term ‘efficacy supplement’ means a supplement

to an approved premarket application under section 351 of

the Public Health Service Act that requires substantive clinical

data.

‘‘(5) The term ‘process for the review of device applications’

means the following activities of the Secretary with respect

to the review of premarket applications, premarket reports,

supplements, and premarket notification submissions:

‘‘(A) The activities necessary for the review of premarket applications, premarket reports, 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

submissions and, where appropriate, the actions necessary

to place them in condition for approval.

‘‘(C) The inspection of manufacturing establishments

and other facilities undertaken as part of the Secretary’s

review of pending premarket applications, premarket

reports, and supplements.

‘‘(D) Monitoring of research conducted in connection

with the review of such applications, reports, supplements,

and submissions.

‘‘(E) Review of device applications subject to section

351 of the Public Health Service Act for an investigational

new drug application under section 505(i) or for an investigational device exemption under section 520(g) and activities conducted in anticipation of the submission of such

applications under section 505(i) or 520(g).

‘‘(F) The development of guidance, policy documents,

or regulations to improve the process for the review of

premarket applications, premarket reports, supplements,

and premarket notification submissions.

‘‘(G) The development of voluntary test methods, consensus standards, or mandatory performance standards

under section 514 in connection with the review of such

applications, reports, supplements, or submissions and

related activities.

‘‘(H) The provision of technical assistance to device

manufacturers in connection with the submission of such

applications, reports, supplements, or submissions.

PUBLIC LAW 107–250—OCT. 26, 2002 116 STAT. 1591

‘‘(I) Any activity undertaken under section 513 or 515(i)

in connection with the initial classification or reclassification of a device or under section 515(b) in connection with

any requirement for approval of a device.

‘‘(J) Evaluation of postmarket studies required as a

condition of an approval of a premarket application under

section 515 or section 351 of the Public Health Service

Act.

‘‘(K) Compiling, developing, and reviewing information

on relevant devices to identify safety and effectiveness

issues for devices subject to premarket applications, premarket reports, supplements, or premarket notification

submissions.

‘‘(6) The term ‘costs of resources allocated for the process

for the review of device applications’ means the expenses

incurred in connection with the process for the review of device

applications for—

‘‘(A) officers and employees of the Food and Drug

Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such

officers, employees, and committees and to contracts with

such contractors;

‘‘(B) management of information, and the acquisition,

maintenance, and repair of computer resources;

‘‘(C) leasing, maintenance, renovation, and repair of

facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary

materials and supplies; and

‘‘(D) collecting fees and accounting for resources 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 average) for April of the preceding

fiscal year divided by such Index for April 2002.

‘‘(8) The term ‘affiliate’ means a business entity that has

a relationship with a second business entity if, directly or

indirectly—

‘‘(A) one business entity controls, or has the power

to control, the other business entity; or

‘‘(B) a third party controls, or has power to control,

both of the business entities.

‘‘SEC. 738. AUTHORITY TO ASSESS AND USE DEVICE FEES.

‘‘(a) TYPES OF FEES.—Beginning on the date of the enactment

of the Medical Device User Fee and Modernization 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 person who submits any of

the following, on or after October 1, 2002, shall be subject

to a fee established under subsection (c)(5) for the fiscal

year involved in accordance with the following:

‘‘(i) A premarket application.

21 USC 379j.

116 STAT. 1592 PUBLIC LAW 107–250—OCT. 26, 2002

‘‘(ii) For a premarket report, a fee equal to the

fee that applies under clause (i). ‘‘(iii) For a panel track supplement, a fee equal

to the fee that applies under clause (i).

‘‘(iv) For a 180-day supplement, a fee equal to

21.5 percent of the fee that applies under clause (i),

subject to any adjustment under subsection (c)(3).

‘‘(v) For a real-time supplement, a fee equal to

7.2 percent of the fee that applies under clause (i).

‘‘(vi) For an efficacy supplement, a fee equal to

the fee that applies under clause (i).

‘‘(vii) For a premarket notification submission, a

fee equal to 1.42 percent of the fee that applies under

clause (i), subject to any adjustment under subsection

(c)(3) and any adjustment under subsection (e)(2)(C)(ii).

‘‘(B) EXCEPTIONS.— ‘‘(i) HUMANITARIAN DEVICE EXEMPTION.—An

application under section 520(m) is not subject to any

fee under subparagraph (A).

‘‘(ii) FURTHER MANUFACTURING USE.—No fee shall

be required under subparagraph (A) for the submission

of a premarket application under section 351 of the

Public Health Service Act for a product licensed for

further manufacturing use only.

‘‘(iii) STATE OR FEDERAL GOVERNMENT SPONSORS.—

No fee shall be required under subparagraph (A) for

a premarket application, premarket report, supplement, or premarket notification submission submitted

by a State or Federal Government entity unless the

device involved is to be distributed commercially.

‘‘(iv) PREMARKET NOTIFICATIONS BY THIRD PARTIES.—No fee shall be required under subparagraph

(A) for a premarket notification submission reviewed

by an accredited person pursuant to section 523.

‘‘(v) PEDIATRIC CONDITIONS OF USE.— ‘‘(I) IN GENERAL.—No fee shall be required

under subparagraph (A) for a premarket application, premarket report, or premarket notification

submission if the proposed conditions of use for

the device involved are solely for a pediatric population. No fee shall be required under such

subparagraph for a supplement if the sole purpose

of the supplement is to propose conditions of use

for a pediatric population.

‘‘(II) SUBSEQUENT PROPOSAL OF ADULT CONDITIONS OF USE.—In the case of a person who submits a premarket application or premarket report

for which, under subclause (I), a fee under

subparagraph (A) is not required, any supplement

to such application that proposes conditions of use

for any adult population is subject to the fee that

applies under such subparagraph for a premarket

application.

‘‘(C) PAYMENT.—The fee required by subparagraph (A)

shall be due upon submission of the premarket application,

premarket report, supplement, or premarket notification

submission except that invoices for applications submitted

PUBLIC LAW 107–250—OCT. 26, 2002 116 STAT. 1593

between October 1, 2002, and the date of the enactment

of the Medical Device User Fee and Modernization Act

of 2002 shall be payable on October 30, 2002. Applicants

submitting portions of applications pursuant to section

515(c)(3) shall pay such fees upon submission of the first

portion of such applications. The fees credited to fiscal

year 2003 under this section shall include all fees payable

from October 1, 2002, through September 30, 2003.

‘‘(D) REFUNDS.— ‘‘(i) APPLICATION REFUSED FOR FILING.—The Secretary shall refund 75 percent of the fee paid under

subparagraph (A) for any application or supplement

that is refused for filing. ‘‘(ii) APPLICATION WITHDRAWN BEFORE FILING.—The

Secretary shall refund 75 percent of the fee paid under

subparagraph (A) for any application or supplement

that is withdrawn prior to the filing decision of the

Secretary. ‘‘(iii) APPLICATION WITHDRAWN BEFORE FIRST

ACTION.—After receipt of a request for a refund of

the fee paid under subparagraph (A) for a premarket

application, premarket report, or supplement that is

withdrawn after filing but before a first action, the

Secretary may return some or all of the fee. The

amount of refund, if any, shall be based on the level

of effort already expended on the review of such

application, report, or supplement. The Secretary shall

have sole discretion to refund a fee or portion of the

fee under this subparagraph. A determination by the

Secretary concerning a refund under this paragraph

shall not be reviewable.

‘‘(b) FEE REVENUE AMOUNTS.—Except as provided in subsections (c), (d), (e), (g), and (h), the fees under subsection (a)

shall be established to generate the following revenue amounts:

$25,125,000 in fiscal year 2003; $27,255,000 in fiscal year 2004;

$29,785,000 in fiscal year 2005; $32,615,000 in fiscal year 2006,

and $35,000,000 in fiscal year 2007. If legislation is enacted after

the date of the enactment of the Medical Device User Fee and

Modernization Act of 2002 requiring the Secretary to fund 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 attributable to the process for the review of device

applications.

‘‘(c) ADJUSTMENTS.—

‘‘(1) INFLATION ADJUSTMENT.—The revenues established in

subsection (b) shall be adjusted by the Secretary by notice,

published in the Federal Register, for a fiscal year to reflect

the greater of—

‘‘(A) the total percentage change that occurred in the

Consumer Price Index for all urban consumers (all items;

U.S. city average) for the 12 month period ending June

30 preceding the fiscal year for which fees are being established, or

‘‘(B) the total percentage change for the previous fiscal

year in basic pay under the General Schedule in accordance

with section 5332 of title 5, United States Code, as adjusted

Federal Register,

publication.

116 STAT. 1594 PUBLIC LAW 107–250—OCT. 26, 2002

by any locality-based comparability payment pursuant to

section 5304 of such title for Federal employees stationed

in the District of Columbia.

The adjustment made each fiscal year by this subsection shall

be added on a compounded basis to the sum of all adjustments

made each fiscal year after fiscal year 2003 under this 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 applications, premarket reports, supplements,

and premarket 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 supporting methodologies.

‘‘(B) Under no circumstances shall the adjustment

result in fee revenues for a fiscal year that are less than

the fee revenues for the fiscal year established in subsection

(b), as adjusted for inflation under paragraph (1).

‘‘(3) COMPENSATING ADJUSTMENT.—After the fee revenues

established in subsection (b) are adjusted for a fiscal year

for inflation in accordance with paragraph (1), and for workload

in accordance with paragraph (2), the fee revenues shall, 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, beginning with fiscal year

2003, fell below the cumulative revenue amounts for such fiscal

years specified in subsection (b), adjusted for such fiscal years

for inflation in accordance with paragraph (1), and for workload

in accordance with paragraph (2).

‘‘(4) FINAL YEAR ADJUSTMENT.—For fiscal year 2007, the

Secretary may, in addition to adjustments under paragraphs

(1) and (2), further increase the fees and fee revenues established in subsection (b) if such adjustment is necessary to

provide for not more than three months of operating reserves

of carryover user fees for the process for the review of device

applications for the first three months of fiscal year 2008.

If such an adjustment is necessary, the rationale for the amount

of the increase shall be contained in the annual notice establishing fee revenues and fees for fiscal year 2007. If the Secretary has carryover user fee balances for such process in

excess of three months of such operating reserves, the adjustment under this paragraph shall not be made.

‘‘(5) ANNUAL FEE SETTING.—The Secretary shall, 60 days

before the start of each fiscal year after September 30, 2002,

establish, for the next fiscal year, and publish in the Federal

Register, fees under subsection (a), based on the revenue

amounts established under subsection (b) and the adjustment

provided under this subsection and subsection (e)(2)(C)(ii),

Federal Register,

publication.

Federal Register,

publication.

PUBLIC LAW 107–250—OCT. 26, 2002 116 STAT. 1595

except that the fees established for fiscal year 2003 shall be

based on a premarket application fee of $154,000. ‘‘(6) LIMIT.—The total amount of fees charged, as adjusted

under this subsection, for a fiscal year may not exceed the

total costs for such fiscal year for the resources allocated for

the process for the review of device applications.

‘‘(d) SMALL BUSINESSES; FEE WAIVER AND FEE REDUCTION

REGARDING PREMARKET APPROVAL FEES.— ‘‘(1) IN GENERAL.—The Secretary shall grant a waiver of

the fee required under subsection (a) for one premarket 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 subsequent

premarket applications, premarket reports, and supplements

where the Secretary finds that the applicant involved is a

small business, the fees specified in clauses (i) through (vi)

of subsection (a)(1)(A) may be paid at a reduced rate in accordance with paragraph (2)(C). ‘‘(2) RULES RELATING TO PREMARKET APPROVAL FEES.—

‘‘(A) DEFINITION.—

‘‘(i) IN GENERAL.—For purposes of this subsection,

the term ‘small business’ means an entity that reported

$30,000,000 or less of gross receipts or sales in its

most recent Federal income tax return for a taxable

year, including such returns of all of its affiliates,

partners, and parent firms.

‘‘(ii) ADJUSTMENT.—The Secretary may adjust the

$30,000,000 threshold established in clause (i) if the

Secretary has evidence from actual experience that

this threshold results in a reduction in revenues from

premarket applications, premarket reports, and 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 Register setting out the

rationale for the adjustment, and the new threshold.

‘‘(B) EVIDENCE OF QUALIFICATION.—An applicant shall

pay the higher fees established by the Secretary each year

unless the applicant submits evidence that it qualifies for

a waiver of the fee or the lower fee rate. The applicant

shall support its claim that it meets the definition under

subparagraph (A) by submission of a copy of its most recent

Federal income tax return for a taxable year, and a copy

of such returns of its affiliates, partners, and parent firms.

which show an amount of gross sales or receipts that

is less than the maximum established in subparagraph

(A). The applicant, and each of such affiliates, partners,

and parent firms, shall certify that the information 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 applicant has no affiliates, partners, or parent firms, respectively.

‘‘(C) REDUCED FEES.—Where the Secretary finds that

the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(5) may

Federal Register,

publication.

Notice.

116 STAT. 1596 PUBLIC LAW 107–250—OCT. 26, 2002

be paid at a reduced rate of 38 percent of the fee established

under such subsection for a premarket application, a premarket report, or a supplement. ‘‘(D) REQUEST FOR FEE WAIVER OR REDUCTION.—An

applicant seeking a fee waiver or reduction under this

subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant

to subsection (a). The decision of the Secretary regarding

whether an entity qualifies for such a waiver or reduction

is not reviewable. ‘‘(e) SMALL BUSINESSES; FEE REDUCTION REGARDING PRE- MARKET NOTIFICATION SUBMISSIONS.— ‘‘(1) IN GENERAL.—Where the Secretary finds that the

applicant involved is a small business, the fee specified in

subsection (a)(1)(A)(vii) may be paid at a reduced rate in accordance with paragraph (2)(C). ‘‘(2) RULES RELATING TO PREMARKET NOTIFICATION 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 Federal income tax return for a taxable year,

including such returns of all of its affiliates, partners,

and parent firms.

‘‘(B) EVIDENCE OF QUALIFICATION.—An applicant shall

pay the higher fees established by the Secretary each year

unless the applicant submits evidence that it qualifies for

the lower fee rate. The applicant shall support its claim

that it meets the definition under subparagraph (A) by

submission of a copy of its most recent Federal income

tax return for a taxable year, and a copy of such returns

of its affiliates, partners, and parent firms. which show

an amount of gross sales or receipts that is less than

the maximum established in subparagraph (A). The

applicant, and each of such affiliates, partners, and parent

firms, shall certify that the information provided is a true

and accurate copy of the actual tax forms they submitted

to the Internal Revenue Service. If no tax forms are submitted for affiliates, partners, or parent firms, the applicant

shall certify that the applicant has no affiliates, partners,

or parent firms, respectively.

‘‘(C) REDUCED FEES.—

‘‘(i) IN GENERAL.—Where the Secretary finds that

the applicant involved meets the definition under

subparagraph (A), the fee for a premarket notification

submission may be paid at 80 percent of the fee that

applies under subsection (a)(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 subsection (c)(5) for premarket notification submissions,

shall determine the revenue amount that would apply

if all such submissions for the fiscal year involved

paid a fee equal to 1.42 percent of the amount that

applies under subsection (a)(1)(A)(i) for premarket

PUBLIC LAW 107–250—OCT. 26, 2002 116 STAT. 1597

applications, and shall adjust 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 applicant seeking

a fee 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 regarding whether an entity qualifies for

such a reduction is not reviewable.

‘‘(f) EFFECT OF FAILURE TO PAY FEES.—A premarket application,

premarket report, supplement, or premarket notification submission

submitted by a person subject to fees under subsection (a) shall

be considered incomplete and shall not be accepted for filing by

the Secretary until all fees owed by such person have been paid.

‘‘(g) CONDITIONS.—

‘‘(1) PERFORMANCE GOALS THROUGH FISCAL YEAR 2005;

TERMINATION OF PROGRAM AFTER FISCAL YEAR 2005.—With

respect to the amount that, under the salaries and expenses

account of the Food and Drug Administration, is appropriated

for a fiscal year for devices and radiological products:

‘‘(A)(i) For each of the fiscal years 2003 and 2004,

the Secretary is expected to meet all of the goals identified

for the fiscal year involved in any letter referred to in

section 101(3) of the Medical Device User Fee and Modernization Act of 2002 (referred to in this paragraph as

‘performance goals’) if the amount so appropriated for such

fiscal year, excluding the amount of fees appropriated for

such fiscal year, is equal to or greater than $205,720,000

multiplied by the adjustment factor applicable to the fiscal

year.

‘‘(ii) For each of the fiscal years 2003 and 2004, if

the amount so appropriated for the fiscal year involved,

excluding the amount of fees appropriated for such fiscal

year, is less than the amount that applies under clause

(i) for such fiscal year, the following applies:

‘‘(I) The Secretary is expected to meet such goals

to the extent practicable, taking into account the

amounts that are available to the Secretary for such

purpose, whether from fees under subsection (a) or

otherwise.

‘‘(II) The Comptroller General of the United States

shall submit to the Congress a report describing

whether and to what extent the Secretary is meeting

the performance goals identified for such fiscal year,

and whether the Secretary will be able to meet all

performance goals identified for fiscal year 2005. A

report under the preceding sentence shall be submitted

to the Congress not later than July 1 of the fiscal

year with which the report is concerned.

‘‘(B)(i) For fiscal year 2005, the Secretary is expected

to meet all of the performance goals identified for the

fiscal year if the total of the amounts so appropriated

for fiscal years 2003 through 2005, excluding the amount

Deadline.

Reports.

116 STAT. 1598 PUBLIC LAW 107–250—OCT. 26, 2002

of fees appropriated for such fiscal years, is equal to or

greater than the sum of— ‘‘(I) $205,720,000 multiplied by the adjustment

factor applicable to fiscal year 2003;

‘‘(II) $205,720,000 multiplied by the adjustment

factor applicable to fiscal year 2004; and

‘‘(III) $205,720,000 multiplied by the adjustment

factor applicable to fiscal year 2005.

‘‘(ii) For fiscal year 2005, if the total of the amounts

so appropriated for fiscal years 2003 through 2005,

excluding the amount of fees appropriated for such fiscal

years, is less than the sum that applies under clause (i)

for fiscal year 2005, the following applies:

‘‘(I) The Secretary is expected to meet such goals

to the extent practicable, taking into account the

amounts that are available to the Secretary for such

purpose, whether from fees under subsection (a) or

otherwise.

‘‘(II) The Comptroller General of the United States

shall submit to the Congress a report describing

whether and to what extent the Secretary is meeting

the performance goals identified for such fiscal year,

and whether the Secretary will be able to meet all

performance goals identified for fiscal year 2006. The

report under the preceding sentence shall be submitted

to the Congress not later than July 1, 2005.

‘‘(C) For fiscal year 2006, fees may not be assessed

under subsection (a) for the fiscal year, and the Secretary

is not expected to meet any performance goals identified

for the fiscal year, if the total of the amounts so appropriated for fiscal years 2003 through 2006, excluding the

amount of fees appropriated for such fiscal years, is less

than the sum of—

‘‘(i) $205,720,000 multiplied by the adjustment

factor applicable to fiscal year 2006; and

‘‘(ii) an amount equal to the sum that applies

for purposes of subparagraph (B)(i).

‘‘(D) For fiscal year 2007, fees may not be assessed

under subsection (a) for the fiscal year, and the Secretary

is not expected to meet any performance goals identified

for the fiscal year, if—

‘‘(i) the amount so appropriated for the fiscal year,

excluding the amount of fees appropriated for the fiscal

year, is less than $205,720,000 multiplied by the

adjustment factor applicable to fiscal year 2007; or

‘‘(ii) pursuant to subparagraph (C), fees were not

assessed under subsection (a) for fiscal year 2006.

‘‘(2) AUTHORITY.—If the Secretary does not assess fees

under subsection (a) during any portion of a fiscal year because

of subparagraph (C) or (D) of paragraph (1) and if at a later

date in such fiscal year the Secretary may assess such fees,

the Secretary may assess and collect such fees, without any

modification in the rate for premarket applications, supplements, premarket reports, and premarket notification submissions, and at any time in such fiscal year, notwithstanding

the provisions of subsection (a) relating to the date fees are

to be paid.

Deadline.

Reports.

PUBLIC LAW 107–250—OCT. 26, 2002 116 STAT. 1599

‘‘(h) CREDITING AND AVAILABILITY OF FEES.— ‘‘(1) IN GENERAL.—Fees authorized under subsection (a)

shall be collected and available for obligation only to the extent

and in the amount provided in advance in appropriation Acts.

Such fees are authorized to be appropriated to remain available

until expended. Such sums as may be necessary may be 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 limitation. 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 available to defray

increases in the costs of the resources allocated for

the process for the review of device applications

(including increases in such costs for an additional

number of full-time equivalent positions in the 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 appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted

116 STAT. 1600 PUBLIC LAW 107–250—OCT. 26, 2002

from the amount of fees that would otherwise be authorized

to be collected under this section pursuant to appropriation

Acts for a subsequent fiscal year.

‘‘(i) COLLECTION OF UNPAID FEES.—In any case where the Secretary does not receive payment of a fee assessed under subsection

(a) within 30 days after it is due, such fee shall be treated as

a claim of the United States Government subject to subchapter

II of chapter 37 of title 31, United States Code. ‘‘(j) WRITTEN REQUESTS FOR REFUNDS.—To qualify for 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 construed to

require that the number of full-time equivalent positions in the

Department of Health and Human Services, for officers, employees,

and advisory committees not engaged in the process of the review

of device applications, be reduced to offset the number of officers,

employees, and advisory committees so engaged.’’. (b) FEE EXEMPTION FOR CERTAIN ENTITIES SUBMITTING PRE- MARKET REPORTS.— (1) IN GENERAL.—A person submitting a premarket report

to the Secretary of Health and Human Services is exempt

from the fee under section 738(a)(1)(A)(ii) of the Federal Food,

Drug, and Cosmetic Act (as added by subsection (a) of this

section) if—

(A) the premarket report is the first such report submitted to the Secretary by the person; and

(B) before October 1, 2002, the person submitted a

premarket application to the Secretary for the same device

as the device for which the person is submitting the 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 Committee on Health, Education,

Labor and Pensions of the Senate a report concerning— (1) the progress of the Food and Drug Administration in

achieving the goals identified in the letters described in section

101(3) during such fiscal year and the future plans of the

Food and Drug Administration for meeting the goals, not later

than 60 days after the end of each fiscal year during which

fees are collected under this part; and

(2) the implementation of the authority for such fees during

such fiscal year, and the use, by the Food and Drug Administration, of the fees collected during such fiscal year, not later

than 120 days after the end of each fiscal year during which

fees are collected under the medical device user-fee program

established under the amendment made by section 102.

SEC. 104. POSTMARKET SURVEILLANCE.

(a) ADDITIONAL AUTHORIZATION OF APPROPRIATIONS.—For the

purpose of carrying out postmarket surveillance of medical devices,

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21 USC 379i

note.

21 USC 379j

note.

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PUBLIC LAW 107–250—OCT. 26, 2002 116 STAT. 1601

there are authorized to be appropriated to the Food and Drug

Administration the following amounts, stated as increases above

the amount obligated for such purpose by such Administration

for fiscal year 2002:

(1) For fiscal year 2003, an increase of $3,000,000.

(2) For fiscal year 2004, an increase of $6,000,000.

(3) For fiscal year 2005 and each subsequent fiscal year,

an increase of such sums as may be necessary.

(b) STUDY.—

(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 devices.

(B) The programmatic improvements, if any, needed

for adequate postmarket surveillance of medical devices.

(C) The amount of funds needed to conduct adequate

postmarket surveillance of medical devices.

(D) The extent to which device companies comply with

the postmarket surveillance requirements, including

postmarket study commitments.

(E) The recommendations of the Secretary as to

whether, and in what amounts, user fees collected under

such user-fee program should be dedicated to postmarket

surveillance if the program is extended beyond fiscal year

2007.

(2) REPORT.—Not later than January 10, 2007, the Secretary shall submit to the Committee on Energy and Commerce

of the House of Representatives, and the Committee on Health,

Education, Labor, and Pensions of the Senate, a report that

describes the findings of the study under paragraph (1).

SEC. 105. CONSULTATION.

(a) IN GENERAL.—In developing recommendations to the Congress for the goals and plans for meeting the goals for the process

for the review of medical device applications for fiscal years after

fiscal year 2007, and for the 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 Committee on Health,

Education, Labor, and Pensions of the Senate, appropriate scientific

and academic experts, health care professionals, representatives

of patient and consumer advocacy groups, and the regulated

industry.

(b) RECOMMENDATIONS.—The Secretary shall publish in the

Federal Register recommendations under subsection (a), after negotiations with the regulated industry; shall present such recommendations to the congressional committees specified in such

paragraph; shall hold a meeting at which the public may present

its views on such recommendations; and shall provide for a period

of 30 days for the public to provide written comments on such

recommendations.

Federal Register,

publication.

21 USC 379i

note.

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116 STAT. 1602 PUBLIC LAW 107–250—OCT. 26, 2002

SEC. 106. EFFECTIVE DATE.

The amendments made by this title shall take effect on the

date of the enactment of this Act, except that fees shall be assessed

for all premarket applications, premarket reports, supplements,

and premarket notification submissions received on or after October

1, 2002, regardless of the date of enactment.

SEC. 107. SUNSET CLAUSE.

The amendments made by this title cease to be effective October

1, 2007, except that section 103 with respect to annual reports

ceases to be effective January 31, 2008.

TITLE II—AMENDMENTS REGARDING

REGULATION OF MEDICAL DEVICES

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 process class II or class III devices that are required

in section 510(h), or inspections of such establishments required

to register pursuant to section 510(i). The owner or operator of

such an establishment that is eligible under paragraph (6) may,

from the list published under paragraph (4), select an accredited

person to conduct such inspections. ‘‘(2) Not later than 180 days after the date of enactment of

this subsection, the Secretary shall publish in the Federal Register

criteria to accredit or deny accreditation to persons who request

to perform the duties specified in paragraph (1). Thereafter, the

Secretary shall inform those requesting accreditation, within 60

days after the receipt of such request, whether the request for

accreditation is adequate for review, and the Secretary shall

promptly act on the request for accreditation. Any resulting 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 accredit or deny accreditation to persons who request to perform

the duties specified in paragraph (1), the Secretary shall accredit

no more than 15 persons who request to perform duties specified

in paragraph (1).

‘‘(3) An accredited person shall, at a minimum, meet the following requirements:

‘‘(A) Such person may not be an employee of the Federal

Government. ‘‘(B) Such person shall be an independent organization

which is not owned or controlled by a manufacturer, supplier,

or vendor of articles regulated under this Act and which has

no organizational, material, or financial affiliation (including

a consultative affiliation) with such a manufacturer, supplier,

or vendor.

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publication.

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note.

21 USC 379i

note.

PUBLIC LAW 107–250—OCT. 26, 2002 116 STAT. 1603

‘‘(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 design, manufacture, promotion, or sale of articles regulated under this Act.

‘‘(E) The operations of such person shall be in accordance

with generally accepted professional and ethical business practices, and such person shall agree in writing that at a minimum

the person will—

‘‘(i) certify that reported information accurately reflects

data reviewed, inspection observations made, other matters

that relate to or may influence compliance with this Act,

and recommendations made during an inspection or at

an inspection’s closing meeting;

‘‘(ii) limit work to that for which competence and

capacity are available;

‘‘(iii) treat information received, records, reports, and

recommendations as confidential commercial or financial

information or trade secret information, except such

information may be made available to the Secretary;

‘‘(iv) promptly respond and attempt to resolve complaints regarding its activities for which it is accredited;

and

‘‘(v) protect against the use, in carrying out paragraph

(1), of any officer or employee of the accredited person

who has a financial conflict of interest regarding any

product regulated under this Act, and annually make available to the public disclosures of the extent to which the

accredited person, and the officers and employees of the

person, have maintained compliance with requirements

under this clause relating to financial conflicts of interest.

‘‘(4) The Secretary shall publish on the Internet site of the

Food and Drug Administration a list of persons who are accredited

under paragraph (2). Such list shall be updated to ensure that

the identity of each accredited person, and the particular activities

for which the person is accredited, is known to the public. The

updating of such list shall be no later than one month after the

accreditation of a person under this subsection or the suspension

or withdrawal of accreditation, or the modification of the particular

activities for which the person is accredited.

‘‘(5)(A) To ensure that persons accredited under this subsection

continue to meet the standards of accreditation, the Secretary shall

(i) audit the performance of such persons on a periodic basis through

the review of inspection reports and inspections by persons designated by the Secretary to evaluate the compliance status of a

device establishment and the performance of accredited persons,

and (ii) take such additional measures as the Secretary determines

to be appropriate.

‘‘(B) The Secretary may withdraw accreditation of any person

accredited under paragraph (2), after providing notice and an 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 suspend

the accreditation of such person during the pendency of the process

under the preceding sentence.

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116 STAT. 1604 PUBLIC LAW 107–250—OCT. 26, 2002

‘‘(6)(A) Subject to subparagraphs (B) and (C), a device establishment is eligible for inspections by persons accredited 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 conducted by

an accredited person—

‘‘(I) the owner or operator of the establishment submits

to the Secretary a notice requesting clearance to use such

a person to conduct the inspection, and the Secretary 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 manufactured,

prepared, propagated, compounded, or processed by the

establishment, at least one of such devices is marketed in

the United States, and the following additional conditions are

met:

‘‘(I) At least one of such devices is marketed, or is

intended to be marketed, in one or more foreign countries,

one of which countries certifies, accredits, or otherwise

recognizes the person accredited under paragraph (2) and

identified under subclause (II) of this clause.

‘‘(II) The owner or operator of the establishment 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, recognizes an inspection of the establishment

by the Secretary, and not later than 30 days after receiving

such statement, the Secretary informs the owner or operator of the establishment that the owner or operator may

submit a notice requesting clearance under clause (ii).

‘‘(iv)(I) In the case of an inspection to be conducted pursuant

to 510(h), persons accredited under paragraph (2) did not 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

inspection of the establishment during the four-year period

preceding the date on which the notice under clause (ii) is

submitted to the Secretary. Such a waiver is deemed to be

granted only if the petition states a commercial reason for

the waiver; the Secretary has not determined that the public

health would be served by granting the waiver; and the owner

or operator of the device establishment has requested in

writing, not later than 18 months following the most recent

inspection of such establishment by a person accredited under

paragraph (2), that the Secretary inspect the establishment

and the Secretary has not conducted an inspection within 30

months after the most recent inspection. With respect to such

a waiver that is granted or deemed to be granted, no additional

such waiver may be granted until after the Secretary has

conducted an inspection of the establishment.

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PUBLIC LAW 107–250—OCT. 26, 2002 116 STAT. 1605

‘‘(II) In the case of an inspection to be conducted pursuant

to 510(i), the Secretary periodically conducts inspections of

the establishment.

‘‘(B)(i) The Secretary shall respond to a notice under 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 selection of an accredited person, or (II) make

a request under clause (ii). If the Secretary fails to respond to

the notice within such 30-day period, the establishment is deemed

to have such clearance, and to have the agreement of the Secretary

for such selection.

‘‘(ii) The request referred to in clause (i)(II) is—

‘‘(I) a request to the device establishment involved to submit

to the Secretary compliance data in accordance with clause

(iii); or

‘‘(II) a request to the establishment, or to the accredited

person identified in the notice under subparagraph (A), for

information concerning the relationship between the establishment and such accredited person, including information about

the number of inspections of the establishment, or other

establishments owned or operated by the owner or operator

of the establishment, that have been conducted by the accredited person.

The Secretary may make both such requests.

‘‘(iii) The compliance data to be submitted by a device 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 inspections

regarding good manufacturing practice or other quality control

audits that, during the preceding two-year period, were conducted

at the establishment by persons other than the owner or operator

of the establishment, together with all other compliance data the

Secretary deems necessary. Data under the preceding sentence

shall demonstrate to the Secretary whether the establishment has

facilitated consistent compliance by promptly correcting any compliance problems identified in such inspections.

‘‘(iv) Not later than 60 days after receiving compliance data

under clause (iii) from a device establishment, the Secretary shall

provide or deny clearance under subparagraph (A). The Secretary

may deny clearance if the Secretary determines that the 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 establishment within such

60-day period, the establishment is deemed to have such clearance.

‘‘(v)(I) A request to an accredited person under clause (ii)(II)

may not seek any information that is not required to be maintained

by such person in records under subsection (f)(1). Not later than

60 days after receiving the information sought by the request,

the Secretary shall agree to, or reject, the selection of such person

by the device establishment involved. The Secretary may reject

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116 STAT. 1606 PUBLIC LAW 107–250—OCT. 26, 2002

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 accordance with this subclause, the Secretary is deemed to have

agreed to the selection.

‘‘(II) If the Secretary rejects the selection of an accredited

person by a device establishment, the establishment may make

an additional selection of an accredited person by submitting to

the Secretary a notice that identifies the additional selection.

Clauses (i) and (ii), and subclause (I) of this clause, apply to the

selection of an accredited person through a notice under the preceding sentence in the same manner and to the same extent as

such provisions apply to a selection of an accredited person through

a notice under subparagraph (A).

‘‘(vi) In the case of 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 establishment requests the review. The review shall commence not later

than 30 days after the establishment requests the review, unless

the Secretary and the establishment otherwise agree.

‘‘(C)(i) In the case of a device establishment for which the

Secretary classified the results of the most recent inspection of

the establishment by a person accredited under paragraph (2) as

‘official action indicated’, the establishment, if otherwise eligible

under subparagraph (A), is eligible for further inspections by 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 Secretary’s own initiative

or a petition of the owner or operator of the establishment, notifies

the establishment that it has clearance to use an accredited person

for the inspections. The Secretary shall respond to such petition

within 30 days after the receipt of the petition.

‘‘(ii) If the Secretary denies a petition under clause (i), the

device establishment involved may, after the expiration of one year

after such denial, again petition the Secretary for a determination

of eligibility for inspection by persons accredited by the Secretary

under paragraph (2). If the Secretary denies such petition, the

Secretary shall provide the establishment with such reasons for

such denial within 60 days after the denial. If, as of the expiration

of 48 months after the receipt of the first petition, the establishment

has not been inspected by the Secretary in accordance with section

510(h), or has not during such period been inspected pursuant

to section 510(i), as applicable, the establishment is eligible for

further inspections by accredited persons.

‘‘(7)(A) Persons accredited under paragraph (2) to conduct

inspections shall record in writing their inspection observations

and shall present the observations to the device establishment’s

designated representative and describe each observation. Additionally, such accredited person shall prepare an inspection report

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PUBLIC LAW 107–250—OCT. 26, 2002 116 STAT. 1607

(including for inspections classified as ‘no action indicated’) in a

form and manner consistent with such reports prepared by

employees and officials designated by the Secretary to conduct

inspections.

‘‘(B) At a minimum, an inspection report under subparagraph

(A) shall identify the persons responsible for good manufacturing

practice compliance at the inspected device establishment, the dates

of the inspection, the scope of the inspection, and shall describe

in detail each observation identified by the accredited person, 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 representative of the

inspected device establishment at the same time, but under no

circumstances later than three weeks after the last day of the

inspection. The report to the Secretary shall be accompanied by

all written inspection observations previously provided to the 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 accredited

person the accredited person discovers a condition that could cause

or contribute to an unreasonable risk to the public health, the

accredited person shall immediately notify the Secretary of the

identification of the device establishment subject to inspection and

such condition.

‘‘(8) Compensation for an accredited person shall be determined

by agreement between the accredited person and the person who

engages the services of the accredited person, and shall be paid

by the person who engages such services.

‘‘(9) Nothing in this subsection affects the authority of the

Secretary to inspect any device establishment pursuant to this

Act.

‘‘(10)(A) For fiscal year 2005 and each subsequent fiscal year,

no device establishment may be inspected during the fiscal year

involved by a person accredited under paragraph (2) 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 subparagraph as the ‘first prior fiscal

year’), the amount obligated by the Secretary for inspections

of device establishments by the Secretary was less than the

adjusted base amount applicable to such first prior fiscal year;

and

‘‘(ii) of the amounts appropriated for salaries and expenses

of the Food and Drug Administration for the fiscal year preceding the first prior fiscal year (referred to in this subparagraph as the ‘second prior fiscal year’), the amount obligated

by the Secretary for inspections of device establishments by

the Secretary was less than the adjusted base amount

applicable to such second prior fiscal year.

‘‘(B)(i) Subject to clause (ii), the Comptroller General of the

United States shall determine the amount that was obligated by

the Secretary for fiscal year 2002 for compliance activities of the

Food and Drug Administration with respect to devices (referred

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116 STAT. 1608 PUBLIC LAW 107–250—OCT. 26, 2002

to in this subparagraph as the ‘compliance budget’), and of such

amount, the amount that was obligated for inspections by the

Secretary of device establishments (referred to in this subparagraph

as the ‘inspection budget’).

‘‘(ii) For purposes of determinations under clause (i), the Comptroller General shall not include in the compliance budget or the

inspection budget any amounts obligated for inspections of device

establishments conducted as part of the process of reviewing

applications under section 515.

‘‘(iii) Not later than March 31, 2003, the Comptroller General

shall complete the determinations required in this subparagraph

and submit to the Secretary and the Congress a reporting describing

the findings made through such determinations.

‘‘(C) For purposes of this paragraph:

‘‘(i) The term ‘base amount’ means the inspection budget

determined under subparagraph (B) for fiscal year 2002.

‘‘(ii) The term ‘adjusted base amount’, in the case of applicability to fiscal year 2003, means an amount equal to the base

amount increased by 5 percent.

‘‘(iii) The term ‘adjusted base amount’, with respect to

applicability to fiscal year 2004 or any subsequent fiscal year,

means the adjusted based amount applicable to the preceding

year increased by 5 percent.

‘‘(11) The authority provided by this subsection terminates on

October 1, 2012.

‘‘(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, Education, Labor and Pensions of the

Senate—

‘‘(A) the number of inspections pursuant to subsections

(h) and (i) of section 510 conducted by accredited persons and

the number of inspections pursuant to such subsections conducted by Federal employees;

‘‘(B) the number of persons who sought accreditation under

this subsection, as well as the number of persons who were

accredited under this subsection;

‘‘(C) the reasons why persons who sought accreditation,

but were denied accreditation, were denied;

‘‘(D) the number of audits conducted by the Secretary of

accredited persons, the quality of inspections conducted by

accredited persons, whether accredited persons are meeting

their obligations under this Act, and whether the number of

audits conducted is sufficient to permit these assessments;

‘‘(E) whether this subsection is achieving the goal of

ensuring more information about device establishment compliance is being presented to the Secretary, and whether that

information is of a quality consistent with information obtained

by the Secretary pursuant to subsection (h) or (i) of section

510;

‘‘(F) whether this subsection is advancing efforts to allow

device establishments to rely upon third-party inspections for

purposes of compliance with the laws of foreign governments;

and

‘‘(G) whether the Congress should continue, modify, or

terminate the program under this subsection.

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PUBLIC LAW 107–250—OCT. 26, 2002 116 STAT. 1609

‘‘(13) The Secretary shall include in the annual report required

under section 903(g) the names of all accredited persons and the

particular activities under this subsection for which each such person is accredited and the name of each accredited person whose

accreditation has been withdrawn during the year.

‘‘(14) Notwithstanding any provision of this subsection, this

subsection does not have any legal effect on any agreement

described in section 803(b) between the Secretary and a foreign

country.’’.

(b) MAINTENANCE OF RECORDS.—Section 704(f) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 374(f)) is amended— (1) in paragraph (1), in the first sentence, by striking ‘‘A person accredited’’ and all that follows through ‘‘shall maintain records’’ and inserting the following: ‘‘An accredited person

described in paragraph (3) shall maintain records’’;

(2) in paragraph (2), by striking ‘‘a person accredited under

section 523’’ and inserting ‘‘an accredited person described in

paragraph (3)’’; and

(3) by adding at the end the following paragraph: ‘‘(3) For purposes of paragraphs (1) and (2), an accredited

person described in this paragraph is a person who— ‘‘(A) is accredited under subsection (g); or

‘‘(B) is accredited under section 523.’’. (c) 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 following: ‘‘For purposes of the preceding

sentence, a person accredited under paragraph (2) of section 704(g)

who is substantially not in compliance with the standards of accreditation under such section, or who poses a threat to public health

or fails to act in a manner that is consistent with the purposes

of such section, shall be considered to have violated a requirement

of this Act that relates to devices.’’.

(d) PROHIBITED ACTS.—Section 301 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 331) is amended by adding at the

end the following: ‘‘(gg) The 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 report under paragraph (7)(A) of such

section; or the knowing failure of such a person to include material

facts in such a report.’’.

(e) CONFORMING AMENDMENT.—Section 510(h) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 360(h)) is amended by

inserting after ‘‘duly designated by the Secretary’’ the following:

‘‘, or by persons accredited to conduct inspections under section

704(g),’’.

SEC. 202. THIRD PARTY REVIEW OF PREMARKET NOTIFICATION.

Section 523 of the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 360m) is amended—

(1) in subsection (c), by striking ‘‘The authority’’ and all

that follows and inserting the following: ‘‘The authority provided by this section terminates October 1, 2007.’’; and

(2) by adding at the end the following subsection:

‘‘(d) REPORT.—Not later than January 10, 2007, the Secretary

shall conduct a study based on the experience under the program

under this section and submit to the Committee on Energy and

Deadline.

116 STAT. 1610 PUBLIC LAW 107–250—OCT. 26, 2002

Commerce of the House of Representatives, and the Committee

on Health, Education, Labor, and Pensions of the Senate, a report

describing the findings of the study. The objectives of the study

shall include determining—

‘‘(1) the number of devices reviewed under this section;

‘‘(2) the number of devices reviewed under this section

that were ultimately cleared by the Secretary;

‘‘(3) the number of devices reviewed under this section

that were ultimately not cleared by the Secretary;

‘‘(4) the average time period for a review under this section

(including the time it takes for the Secretary to review a

recommendation of an accredited person under subsection (a)

and determine the initial device classification);

‘‘(5) the average time period identified in paragraph (4)

compared to the average time period for review of devices

solely by the Secretary pursuant to section 510(k);

‘‘(6) if there is a difference in the average time period

under paragraph (4) and the average time period under paragraph (5), the reasons for such difference;

‘‘(7) whether the quality of reviews under this section for

devices for which no guidance has been issued is qualitatively

inferior to reviews by the Secretary for devices for which no

guidance has been issued;

‘‘(8) whether the quality of reviews under this section of

devices for which no guidance has been issued is qualitatively

inferior to reviews under this section of devices for which guidance has been issued;

‘‘(9) whether this section has in any way jeopardized or

improved the public health;

‘‘(10) any impact of this section on resources available

to the Secretary to review reports under section 510(k); and

‘‘(11) any suggestions for continuation, modification

(including contraction or expansion of device eligibility), or

termination of this section that the Secretary determines to

be appropriate.’’.

SEC. 203. DEBARMENT OF ACCREDITED PERSONS.

Section 306 of the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 335a) is amended by adding at the end the following subsection:

‘‘(m) DEVICES; MANDATORY DEBARMENT REGARDING THIRDPARTY INSPECTIONS AND REVIEWS.—

‘‘(1) IN GENERAL.—If the Secretary finds that a person

has been convicted of a felony under section 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 following periods:

‘‘(A) The period of debarment of a person (other than

an individual) shall not be less than 1 year or more than

10 years, but if an act leading to a subsequent debarment

under such paragraph occurs within 10 years after such

person has been debarred under such paragraph, the period

of debarment shall be permanent.

‘‘(B) The debarment of an individual shall be permanent.

PUBLIC LAW 107–250—OCT. 26, 2002 116 STAT. 1611

‘‘(3) TERMINATION OF DEBARMENT; JUDICIAL REVIEW; OTHER

MATTERS.—Subsections (c)(3), (d), (e), (i), (j), and (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 subsection

(a)(1), or an individual who is debarred under subsection (a)(2),

respectively.’’.

SEC. 204. DESIGNATION AND REGULATION OF COMBINATION PRODUCTS.

Section 503(g) of the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 353(g)) is amended—

(1) in paragraph (1)—

(A) in the first sentence, by striking ‘‘shall designate

a component of the Food and Drug Administration’’ and

inserting ‘‘shall in accordance with this subsection assign

an agency center’’; and

(B) in each of subparagraphs (A) through (C), by

striking ‘‘the persons charged’’ and inserting ‘‘the agency

center charged’’;

(2) by redesignating paragraph (4) as paragraph (5);

(3) by inserting after paragraph (3) the following 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 premarket review of such products, and consistent and appropriate postmarket regulation of like products subject to the same statutory requirements to the extent permitted

by law. Additionally, the office shall, in determining whether a

product is to be designated a combination product, consult with

the component within the Office of the Commissioner of Food and

Drugs that is responsible for such determinations. Such office

(referred to in this paragraph as the ‘Office’) shall have appropriate

scientific and medical expertise, and shall be headed by a director.

‘‘(B) In carrying out this subsection, the Office shall, for each

combination product, promptly assign an agency center with primary jurisdiction in accordance with paragraph (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 involving more than one agency center.

‘‘(ii) In order to ensure the timeliness of the premarket review

of a combination product, the agency center with primary jurisdiction for the product, and the consulting agency center, shall be

responsible to the Office with respect to the timeliness of the

premarket review.

‘‘(D) In carrying out this subsection, the Office shall ensure

the consistency and appropriateness of postmarket regulation of

like products subject to the same statutory requirements to the

extent permitted by law.

‘‘(E)(i) Any dispute regarding the timeliness of the premarket

review of a combination product may be presented to the Office

for resolution, unless the dispute is clearly premature.

Deadline.

116 STAT. 1612 PUBLIC LAW 107–250—OCT. 26, 2002

‘‘(ii) During the review process, any dispute regarding the substance of the premarket review may be presented to the Commissioner of Food and Drugs after first being considered by the agency

center with primary jurisdiction of the premarket review, under

the scientific dispute resolution procedures for such center. The

Commissioner of Food and Drugs shall consult with the Director

of the Office in resolving the substantive dispute.

‘‘(F) The Secretary, acting through the Office, shall review

each agreement, guidance, or practice of the Secretary that is specific to the assignment of combination products to agency centers

and shall determine whether the agreement, guidance, or practice

is consistent with the requirements of this subsection. In carrying

out such review, the Secretary shall consult with stakeholders and

the directors of the agency centers. After such consultation, the

Secretary shall determine whether to continue in effect, modify,

revise, or eliminate such agreement, guidance, or practice, and

shall publish in the Federal Register a notice of the availability

of such modified or revised agreement, guidance or practice. Nothing

in this paragraph shall be construed as preventing the Secretary

from following each agreement, guidance, or practice until continued, modified, revised, or eliminated.

‘‘(G) Not later than one year after the date of the enactment

of this paragraph and annually thereafter, the Secretary shall report

to the appropriate committees of Congress on the activities and

impact of the Office. The report shall include provisions—

‘‘(i) describing the numbers and types of combination products under review and the timeliness in days of such assignments, reviews, and dispute resolutions;

‘‘(ii) identifying the number of premarket reviews of such

products that involved a consulting agency center; and

‘‘(iii) describing improvements in the consistency of

postmarket regulation of combination products.

‘‘(H) Nothing in this paragraph shall be construed to limit

the regulatory authority of any agency center.’’; and

(4) in paragraph (5) (as redesignated by paragraph (2)

of this section)—

(A) by redesignating subparagraphs (A) and (B) as

subparagraphs (B) and (C), respectively; and

(B) by inserting before subparagraph (B) the following

subparagraph:

‘‘(A) The term ‘agency center’ means a center or alternative

organizational component of the Food and Drug 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 reviews by centers other than

the Center for Devices and Radiological Health. Such report shall

include information on the times required to log in and review

original submissions and supplements, times required to review

manufacturers’ replies to submissions, and times to approve or

clear such devices. Such report shall contain the Secretary’s recommendations on any measures needed to improve performance

including, but not limited to, the allocation of additional resources.

Deadline.

21 USC 360e

note.

Deadline.

Reports.

Federal Register,

publication.

Notice.

PUBLIC LAW 107–250—OCT. 26, 2002 116 STAT. 1613

Such report also shall include the Secretary’s specific recommendation on whether responsibility for regulating such devices should

be reassigned to those persons within the Food and Drug Administration who are primarily charged with regulating other types of

devices, and whether such a transfer could have a deleterious

impact on the public health and on the safety of such devices.

SEC. 206. ELECTRONIC LABELING.

Section 502(f) of the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 352(f)) is amended by adding at the end the following:

‘‘Required labeling for prescription devices intended for use in

health care facilities may be made available solely by electronic

means provided that the labeling complies with all applicable

requirements of law and, that the manufacturer affords health

care facilities the opportunity to request the labeling in paper

form, and after such request, promptly provides the health care

facility the requested information without additional cost.’’.

SEC. 207. ELECTRONIC REGISTRATION.

Section 510 of the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 360) is amended by adding at the end the following:

‘‘(p) Registrations under subsections (b), (c), (d), and (i)

(including the submission of updated information) shall be 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 requesting 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 Cosmetic Act

(21 U.S.C. 360e(c)) is amended by adding at the end the following:

‘‘(3)(A) Prior to the submission of an application under this

subsection, the Secretary shall accept and review any portion of

the application that the applicant and the Secretary agree is 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 portion of a

submission under subparagraph (A) is unacceptable, the Secretary

shall, in writing, provide to the applicant a description of any

deficiencies in such portion and identify the information that is

required to correct these deficiencies, unless the applicant is no

longer pursuing the application.’’.

116 STAT. 1614 PUBLIC LAW 107–250—OCT. 26, 2002

SEC. 210. PEDIATRIC EXPERTISE REGARDING CLASSIFICATION-PANEL

REVIEW OF PREMARKET APPLICATIONS.

Section 515(c) of the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360e(c)), as amended by section 302(c)(2)(A) of this

Act, is amended in paragraph (3) by adding at the end the following:

‘‘Where appropriate, the Secretary shall ensure that such panel

includes, or consults with, one or more pediatric experts.’’.

SEC. 211. INTERNET LIST OF CLASS II DEVICES EXEMPTED FROM

REQUIREMENT OF PREMARKET NOTIFICATION.

Section 510(m)(1) of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 360(m)(1)) is amended by adding at the end the

following: ‘‘The Secretary shall publish such list on the Internet

site of the Food and Drug Administration. The list so published

shall be updated not later than 30 days after each revision of

the list by the Secretary.’’.

SEC. 212. STUDY BY INSTITUTE OF MEDICINE OF POSTMARKET

SURVEILLANCE REGARDING PEDIATRIC POPULATIONS.

(a) IN GENERAL.—The Secretary of Health and Human Services

(referred to in this section as the ‘‘Secretary’’) shall request the

Institute of Medicine to enter into an agreement with the Secretary

under which such Institute conducts a study for the purpose of

determining whether the system under the Federal Food, Drug,

and Cosmetic Act for the postmarket surveillance of medical devices

provides adequate safeguards regarding the use of devices in 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 duration to evaluate the

impact of growth and development for the number of years

that the child will have the implant, and whether the studies

are adequate to evaluate how children’s active lifestyles may

affect the failure rate and longevity of the implant; and

(2) whether the postmarket surveillance by the Food and

Drug Administration of medical devices used in pediatric populations is sufficient to provide adequate safeguards for such

populations, taking into account the Secretary’s monitoring of

commitments made at the time of approval of medical devices,

such as phase IV trials, and the Secretary’s monitoring and

use of adverse reaction reports, registries, and other postmarket

surveillance activities.

(c) REPORT TO CONGRESS.—The Secretary shall ensure that,

not later than four years after the date of the enactment of this

Act, a report describing the findings of the study under subsection

(a) is submitted to the Congress. The report shall include any

recommendations of the Secretary for administrative or legislative

changes to the system of postmarket surveillance referred to in

such subsection.

SEC. 213. GUIDANCE REGARDING PEDIATRIC DEVICES.

Not later than 270 days after the date of the enactment of

this Act, the Secretary of Health and Human Services shall issue

guidance on the following:

Deadline.

21 USC 360j

note.

Deadline.

21 USC 360l

note.

PUBLIC LAW 107–250—OCT. 26, 2002 116 STAT. 1615

(1) The type of information necessary to provide reasonable

assurance of the safety and effectiveness of medical devices

intended for use in pediatric populations.

(2) Protections for pediatric subjects in clinical 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 following with respect to

breast implants:

(1) The content of information typically provided by health

professionals to women who consult with such professionals

on the issue of whether to undergo breast implant surgery.

(2) Whether such information is provided by physicians

or other health professionals, and whether the information

is provided verbally or in writing, and at what point in the

process of determining whether to undergo surgery is such

information provided.

(3) Whether the information presented, as a whole, provides

a complete and 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 updated.

(B) Whether such process provides written explanations of the criteria for being subjects in the research.

(C) The point at which, in the planning or conduct

of the research, the women are provided information

regarding the provision of informed consent to be subjects.

(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 NATIONAL

INSTITUTES OF HEALTH.

(a) REPORT ON STATUS OF CURRENT RESEARCH.—Not later than

180 days after the date of the enactment of this Act, the Director

of the National Institutes of Health shall submit to the Congress

a report describing the status of research on breast implants (as

defined in section 213(c)) being conducted or supported by such

Institutes.

(b) RESEARCH ON LONG-TERM IMPLICATIONS.—Part H of title

IV of the Public Health Service Act (42 U.S.C. 289 et seq.) is

amended by adding at the end of the following section:

‘‘SEC. 498C. BREAST IMPLANT RESEARCH.

‘‘(a) IN GENERAL.—The Director of NIH may conduct or support

research to examine the long-term health implications of silicone

42 USC 289g–3.

Deadline.

Reports.

42 USC 289g–3

note.

116 STAT. 1616 PUBLIC LAW 107–250—OCT. 26, 2002

breast implants, both gel and saline filled. Such research studies

may include the following: ‘‘(1) Developing and examining techniques to measure 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 MEDICAL DEVICES.

(a) IN GENERAL.—Section 502 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 352) is amended by adding at the end

the following:

‘‘(u) If it is a device, unless it, or an attachment thereto,

prominently and conspicuously bears the name of the manufacturer

of the device, a generally recognized abbreviation of such name,

or a unique and generally recognized symbol identifying such manufacturer, except that the Secretary may waive any requirement

under this paragraph for the device if the Secretary determines

that compliance with the requirement is not feasible for the device

or would compromise the provision of reasonable assurance of the

safety or effectiveness of the device.’’.

(b) EFFECTIVE DATE.—The amendment made by subsection (a)

takes effect 18 months after the date of the enactment of this

Act, and only applies to devices introduced or delivered for introduction into interstate commerce after such effective date.

SEC. 302. SINGLE-USE MEDICAL DEVICES.

(a) REQUIRED STATEMENTS ON LABELING.—

(1) IN GENERAL.—Section 502 of the Federal Food, Drug,

and Cosmetic Act, as amended by section 301 of this Act,

is amended by adding at the end the following:

‘‘(v) If it is a reprocessed single-use device, unless all labeling

of the device prominently and conspicuously bears the statement

‘Reprocessed device for single use. Reprocessed by ll.’ The name

of the manufacturer of the reprocessed device shall be placed in

the space identifying the person responsible for reprocessing.’’.

(2) EFFECTIVE DATE.—The amendment made by paragraph

(1) takes effect 15 months after the date of the enactment

of this Act, and only applies to devices introduced or delivered

for introduction into 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 subsection 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 sterilization, and functional performance demonstrating

21 USC 352 note.

21 USC 352 note.

PUBLIC LAW 107–250—OCT. 26, 2002 116 STAT. 1617

that the single-use device will remain substantially equivalent

to its predicate device after the maximum number of times

the device is reprocessed as intended by the person submitting

the premarket notification. Within six months after enactment

of this subsection, the Secretary shall publish in the Federal

Register a list of the 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 subsection (k) that

was submitted to the Secretary before the publication of the

initial list under subparagraph (A), or any revision thereof,

and was for a device or type of device included on such list,

the person who submitted the report under subsection (k) shall

submit validation data as described in subparagraph (A) to

the Secretary not later than nine months after the publication

of the list. During such nine-month period, the Secretary may

not take any action under this Act against such device solely

on the basis that the validation data for the device have not

been submitted to the Secretary. After the submission of the

validation data to the Secretary, the Secretary may not determine that the device is misbranded under section 502(o),

adulterated under section 501(f)(1)(B), or take action against

the device under section 301(p) for failure to provide any

information required by subsection (k) until (i) the review is

terminated by withdrawal of the submission of the report under

subsection (k); (ii) the Secretary finds the data to be acceptable

and issues a letter; or (iii) the Secretary determines that the

device is not substantially equivalent to a predicate device.

Upon a determination that a device is not substantially 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,

require that the report include the validation data specified

in subparagraph (A).

‘‘(D) Section 502(o) applies with respect to the failure of

a report under subsection (k) to include validation data required

under subparagraph (A).

‘‘(2) With respect to critical or semi-critical reprocessed singleuse 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 assurance of the safety and

effectiveness of the devices. The Secretary shall publish in

the Federal Register a list of the devices or types of devices

so identified, and shall revise the list as appropriate. The

exemption for each device or type included on the list is 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).

Federal Register,

publication.

Deadline.

Federal Register,

publication.

116 STAT. 1618 PUBLIC LAW 107–250—OCT. 26, 2002

‘‘(B) For each device or type of device included on the

list under subparagraph (A), a report under subsection (k)

shall be submitted to the Secretary not later than 15 months

after the publication of the initial list, or a revision of the

list, whichever terminates the exemption for the device. During

such 15-month period, the Secretary may not take any action

under this Act against such device solely on the basis that

such report has not been submitted to the Secretary. After

the submission of the report to the Secretary the Secretary

may not determine that the device is misbranded under section

502(o), adulterated under section 501(f)(1)(B), or take action

against the device under section 301(p) for failure to provide

any information required by subsection (k) until (i) the review

is terminated by withdrawal of the submission; (ii) the 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 initial list

under subparagraph (A) shall be published not later than 18

months after the effective date of this subsection. In the case

of critical devices, the initial list under such subparagraph

shall be published not later than six months after such effective

date.

‘‘(D) Section 502(o) applies with respect to the failure to

submit a report under subsection (k) that is required pursuant

to subparagraph (A), including a failure of the report to include

validation data required in such subparagraph.

‘‘(E) The termination under subparagraph (A) of an 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 Federal 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 approval’’; 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 report seeking

premarket approval for a class III device referred to in subsection

(a) that is a reprocessed single-use device. Such a report shall

contain the following:

‘‘(i) The device name, including both the trade or 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.

Deadlines.

PUBLIC LAW 107–250—OCT. 26, 2002 116 STAT. 1619

‘‘(iv) Proposed labels, labeling, and advertising sufficient

to describe the device, its intended use, and directions for

use.

‘‘(v) Full reports of all information, published or known

to or which should be reasonably known to the applicant, 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 reprocessing and packing

of the device.

‘‘(viii) Such samples of the device that the Secretary may

reasonably require.

‘‘(ix) A financial certification or disclosure statement or

both, as required by part 54 of title 21, Code of Federal Regulations.

‘‘(x) A statement that the applicant believes to the best

of the applicant’s knowledge that all data and information

submitted to the Secretary are truthful and accurate and that

no material fact has been omitted in the report.

‘‘(xi) Any additional data and information, including

information of the type required in paragraph (1) for an application under such paragraph, that the Secretary determines is

necessary to determine whether there is reasonable assurance

of safety and effectiveness for the reprocessed device.

‘‘(xii) Validation data described in section 510(o)(1)(A) that

demonstrates that the reasonable assurance of the safety or

effectiveness of the device will remain after the maximum

number of times the device is reprocessed as intended by the

person submitting such report.

‘‘(B) In the case of a class III device referred to in subsection

(a) that is a reprocessed single-use device:

‘‘(i) Subparagraph (A) of this paragraph applies in lieu

of paragraph (1).

‘‘(ii) Subject to clause (i), the provisions of this section

apply to a report under subparagraph (A) to the same extent

and in the same manner as such provisions apply to an application under paragraph (1).

‘‘(iii) Each reference in other sections of this Act to an

application under this section, other than such a reference

in section 737 or 738, shall be considered to be a reference

to a report under subparagraph (A).

‘‘(iv) Each reference in other sections of this Act to a device

for which an application under this section has been approved,

or has been denied, suspended, or withdrawn, other than such

a reference in section 737 or 738, shall be considered to be

a reference to a device for which a report under subparagraph

(A) has been approved, or has been denied, suspended, or

withdrawn, respectively.’’.

(d) DEFINITIONS.—Section 201 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321) is amended by adding at the end

the following:

‘‘(ll)(1) The term ‘single-use device’ means a device that is

intended for one use, or on a single patient during a single procedure.

116 STAT. 1620 PUBLIC LAW 107–250—OCT. 26, 2002

LEGISLATIVE HISTORY—H.R. 5651:

CONGRESSIONAL RECORD, Vol. 148 (2002):

Oct. 16, considered and passed House.

Oct. 17, considered and passed Senate.

WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 38 (2002):

Oct. 26, 28, Presidential remarks and statement.

Æ

‘‘(2)(A) The term ‘reprocessed’, with respect to a single-use

device, means an original device that has previously been used

on a patient and has been subjected to additional processing and

manufacturing for the purpose of an additional single use on a

patient. The subsequent processing and manufacture of a

reprocessed single-use device shall result in a device that is

reprocessed within the meaning of this definition.

‘‘(B) A single-use device that meets the definition under clause

(A) shall be considered a reprocessed device without regard to

any description of the device used by the manufacturer of the

device or other persons, including a description that uses the term

‘recycled’ rather than the term ‘reprocessed’.

‘‘(3) The term ‘original device’ means a new, unused singleuse device.

‘‘(mm)(1) The term ‘critical reprocessed single-use device’ means

a reprocessed single-use device that is intended to contact normally

sterile tissue or body spaces during use.

‘‘(2) The term ‘semi-critical reprocessed single-use device’ means

a reprocessed single-use device that is intended to contact intact

mucous membranes and not penetrate normally sterile areas of

the body.’’.

SEC. 303. MEDWATCH.

Not later than 6 months after the date of the enactment of

this Act, the Secretary of Health and Human Services shall modify

the MedWatch mandatory and voluntary forms to facilitate the

reporting of information by user facilities or distributors as appropriate relating to reprocessed single-use devices, including the name

of the reprocessor and whether the device has been reused.

Approved October 26, 2002.

Deadline.