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Deadlines.

“(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(0), 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 (1) or (m) for a critical or semicritical reprocessed single-use device does not terminate the exemption under subsection (1) or (m) for the original device.".

(c) PREMARKET REPORT.-Section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) is amended

(1) in subsection (a), in the matter after and below 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.

“(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(0)(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:

"(11)(1) The term 'single-use device' means a device that is intended for one use, or on a single patient during a single procedure.

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“(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.

Deadline.

Approved October 26, 2002.

LEGISLATIVE HISTORY-H.R. 5651:
CONGRESSIONAL RECORD, Vol. 148 (2002):

Oct. 16, considered and passed House.

Oct. 17, considered and passed Senate.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 38 (2002):

Oct. 26, 28, Presidential remarks and statement.

.........

Page

Page
A

Born-Alive Infants Protection Act
of 2002 ....

926
Accountability of Tax Dollars Act Buffalo Bayou National Heritage
of 2002 ....

2049
Area Study Act .....

2883
Afghanistan Freedom Support Act Burnt, Malheur, Owyhee, and
of 2002 .......

2797 Powder River Basin Water
Agricultural Bioterrorism

Optimization Feasibility Study
Protection Act of 2002 ....
647 Act of 2002 ......

.... 1485
Allegheny Portage Railroad
National Historic Site

с
Boundary Revision Act............ 3069 California Five Mile Regional
American Servicemembers'

Learning Center Transfer
Protection Act of 2002 .....

899
Act

2982
Andean Trade Promotion and Drug

Caribbean National Forest Wild
Eradication Act.........

1023

and Scenic Rivers Act of
Animal Health Protection Act ........... 494

2002 ....

3027
Antitrust Modernization

Cedar Creek and Belle Grove
Commission Act of 2002 ............. 1856

National Historical Park
Antitrust Technical Corrections

Act ....

...... 3104
Act of 2002 .....

1921 Cherokee, Choctaw, and
Anton's Law

2772 Chickasaw Nations Claims
Appalachian Regional

Settlement Act...

2845
Development Act Amendments

Chief Human Capital Officers Act
of 2002 .....
.... 66 of 2002

2287
Armed Forces Domestic Security

Child Status Protection Act..

927
Act ........

2455 Civil War Battlefield Preservation
Arming Pilots Against Terrorism

Act of 2002 .....

3016
Act ....

2300 Clark County Conservation of
Asian Elephant Conservation

Public Land and Natural
Reauthorization Act of 2002. 13

Resources Act of 2002................. 1994
Atomic Energy Defense Act

2756 Clean Water for the Americas
Auction Reform Act of 2002

715 Partnership Act of 2002 .......... 1402
Authorization for Use of Military

Clergy Housing Allowance
Force Against Iraq Resolution

Clarification Act of 2002 ................ 583
of 2002 ...

1500 Coast Guard Authorization Act for

Fiscal Year 2003 ...... ........ 2133

Coast Guard Personnel and
B

Maritime Safety Act of 2002 ....... 2102
Bainbridge Island Japanese-

Commercial Reusable In-Space
American Memorial Study Act

Transportation Act of 2002 ......... 1573
of 2002 .....

3024 Community Access to Emergency
Benign Brain Tumor Cancer

Defibrillation Act of 2002 ..... 634
Registries Amendment Act ......... 1743 Confidential Information
Benjamin Franklin Tercentenary

Protection and Statistical
Commission Act ........

739

Efficiency Act of 2002 ................ 2962
Big Sur Wilderness and

Congressional Hunger Fellows Act

335
Conservation Act of 2002 ............. 3071

of 2002
Bipartisan Campaign Reform Act

Consequences for Juvenile

Offenders Act of 2002 ............ 1859
of 2002

81
Bipartisan Trade Promotion

Corporate and Criminal Fraud

Accountability Act of 2002 ........... 800
Authority Act of 2002

993

Corporate Fraud Accountability
Black Lung Consolidation of

Act of 2002 .......

807
Administrative Responsibility

Counterintelligence Enhancement
Act ......

1925
Act of 2002 ......

2432
Bob Stump National Defense

Court Services and Offender
Authorization Act for Fiscal

Supervision Agency Interstate
Year 2003

2458

Supervision Act of 2002 .............. 2353
Booker T. Washington National

Crime-Free Rural States Act of
Monument Boundary

2002 ......

1834
Adjustment Act of 2002

1054 Criminal Justice Coordinating
Border Commuter Student Act of

Council Restructuring Act of
2002 ......
1923 2002 .....

........ 581

NOTE: Part 1 contains pages 1-810; Part 2 contains pages 811-1620; Part 3 contains pages 1621-2456; Part 4 contains

pages 2457-3357. Each part contains entire Popu Name and Subject Indexes.

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Page

Page
Criminal Law Technical

Fisheries Conservation Act of
Amendments Act of 2002
1806 2002.

3094
Critical Infrastructure Information Flight 93 National Memorial
Act of 2002 .................
2150 Act

1345
Customs Border Security Act of

Food Stamp Reauthorization Act of
2002 .........
972 2002 .........

305
Cyber Security Enhancement Act Foreign Relations Authorization
of 2002 .....

2156 Act, Fiscal Year 2003 .................. 1350
Cyber Security Research and

Fort Clatsop National Memorial
Development Act

2367 Expansion Act of 2002 ............ 1333

Freedom Investment Act of
D
2002 .......

1405
Dam Safety and Security Act of
2002 ......

2450
Daniel Patrick Moynihan Lake

Gerald B. H. Solomon Freedom
Champlain Basin Program Act

Consolidation Act of 2002.......... 590
of 2002 ........

2358 Great Lakes and Lake Champlain
Department of Defense

Act of 2002 .......

2355
Appropriations Act, 2003.............. 1519 Great Lakes Legacy Act of 2002........ 2355
Department of State Authorization

Guam Foreign Investment Equity
Act, Fiscal Year 2003 ...... 1355

Act ...........

1051
Department of Veterans Affairs

Guam War Claims Review
Emergency Preparedness Act

Commission Act ........

2873
of 2002

...... 2024

Gunn McKay Nature Preserve
District of Columbia College Access

Act

3026
Improvement Act of 2002 ........ 118
Dot Kids Implementation and

H
Efficiency Act of 2002 ................. 2766 Health Care Safety Net
Drug Abuse Education, Prevention,

Amendments of 2002......... 1621
and Treatment Act of 2002.......... 1792 Help America Vote Act of 2002..... 1666

Hematological Cancer Research
E

Investment and Education Act
E-Government Act of 2002...........

of 2002 .............

......... 541
2899

Holocaust Restitution Tax Fairness
East Timor Transition to

Act of 2002

3015
Independence Act of 2002 .......... 1399 Homeland Security Act of 2002..... 2135
Education Sciences Reform Act of

Homeland Security Information
2002 .........

.... 1941

Sharing Act......... ....... 2252, 2413
Educational Technical Assistance

Homestead National Monument of
Act of 2002 ......

.... 1975

America Additions Act ............... 2871
Enhanced Border Security and

Humboldt Project Conveyance
Visa Entry Reform Act of

Act ..........

2016
2002 ........

543 Hydrographic Services
Enterprise Integration Act of

Improvement Act Amendments
2002 ........

1936
of 2002 ....

....... 3079
Export-Import Bank
Reauthorization Act of 2002 ......... 698

I
F

Improper Payments Information
Act of 2002 ......

2350
Fallon Rail Freight Loading

Incentive Grants for Local
Facility Transfer Act ........ .... 2887

Delinquency Prevention
Family Sponsor Immigration Act of

Programs Act of 2002

1894
2002 .......

74 Indian Financing Amendments Act
Farm Security and Rural

of 2002 .....

2835
Investment Act of 2002......

134 Inland Flood Forecasting and
Federal Information Security

Warning System Act of 2002 ....... 1731
Management Act of 2002 ... 2259, 2946 Intellectual Property and High
Federal Judiciary Protection Act of

Technology Technical
2002 .........

....... 1818 Amendments Act of 2002 ..... 1901
FHA Downpayment Simplification Intelligence Authorization Act for
Act of 2002..

....... 2792 Fiscal Year 2003...... ....... 2383

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