United States · Bill · HR
H.R. 3580 (107th)
Medical Device User Fee and Modernization Act of 2002
Introduced
20 December 2001
Last action
15 October 2002 · Committee
Status
Supplemental report filed by the Committee on Energy and Commerce, H. Rept. 107-728, Part II.
Sponsors
Rep. Greenwood, James C. [R-PA-8], Rep. Eshoo, Anna G. [D-CA-18], Rep. Upton, Fred [R-MI-6], Rep. Pallone, Frank [D-NJ-6], Rep. Deutsch, Peter [D-FL-20], Rep. Towns, Edolphus [D-NY-10], Rep. Bryant, Ed [R-TN-7], Rep. Barton, Joe [R-TX-6], Rep. Pickering, Charles W. "Chip" [R-MS-3], Rep. Engel, Eliot L. [D-NY-16], Rep. Luther, Bill [D-MN-6], Rep. Ramstad, Jim [R-MN-3], Rep. Rush, Bobby L. [D-IL-1], Rep. Ehrlich, Robert L., Jr. [R-MD-2], Rep. Wynn, Albert Russell [D-MD-4], Sen. Burr, Richard [R-NC], Rep. Roukema, Marge [R-NJ-5], Rep. Pitts, Joseph R. [R-PA-16], Rep. Whitfield, Ed [R-KY-1], Rep. Norwood, Charles W. [R-GA-9], Rep. Johnson, Nancy L. [R-CT-5], Rep. Hall, Ralph M. [R-TX-4], Rep. Ford, Harold E., Jr. [D-TN-9], Rep. Kennedy, Mark R. [R-MN-6]
Subjects
Healthcare
Source updated
7 April 2025
Summary
Medical Device Amendments of 2001 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to establish within the Office of the Commissioner of Food and Drugs the Office of Combination Products and Product Jurisdiction to designate the component of the Food and Drug Administration with primary or exclusive responsibility for the premarket and postmarket regulation of drugs, devices, and biological products. Authorizes the Commissioner to establish a fellowship program to augment the scientific expertise of the agency component responsible for regulating devices. Revises or sets forth requirements concerning: (1) facility inspection by nongovernment inspectors; (2) outside expert review (accredited third parties) of applications for devices subject to premarket notification; (3) designating priority devices for the treatment of serious diseases or conditions; (4) manufacturers and importers reports only for types of devices requiring malfunction reporting; (5) labeling for intended use of devices found substantially equivalent to legally marketed devices; (6) notification of false or misleading proposed labeling: (7) approving supplements to approved applications seeking to add a specification of a subpopulation under an approved condition of use; (8) using the least burdensome scientific evidence required to demonstrate a device's effectiveness; (9) investigational plans examining the safety, effectiveness or substantial equivalence of a device; (10) notification of deficiencies; (11) the guidance development process utilizing nongovernment employees; (12) modular review of applications; (13) registration; and (14) electronic labeling.
This text is taken from the official record. PoliticalRepo does not editorialize.
Timeline
20 December 2001
Introduced
Referred to the House Committee on Energy and Commerce.
Source: IntroReferral
20 December 2001
Introduced
Introduced in House
Source: IntroReferral
20 December 2001
Introduced
Introduced in House
Source: IntroReferral
28 December 2001
Referred
Referred to the Subcommittee on Health.
Source: Committee
2 October 2002
Reported
Ordered to be Reported (Amended) by Voice Vote.
Source: Committee
2 October 2002
Committee
Committee Consideration and Mark-up Session Held.
Source: Committee
7 October 2002
Vote
At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed until Oct. 8.
Source: Floor
7 October 2002
Floor
DEBATE - The House proceeded with forty minutes of debate on H.R. 3580.
Source: Floor
7 October 2002
Floor
Considered under suspension of the rules. (consideration: CR H7153-7164)
Source: Floor
7 October 2002
Floor
Mr. Burr moved to suspend the rules and pass the bill, as amended.
Source: Floor
7 October 2002
Calendars
Placed on the Union Calendar, Calendar No. 455.
Source: Calendars
7 October 2002
Reported
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 107-728.
Source: Committee
7 October 2002
Reported
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 107-728.
Source: Committee
9 October 2002
Introduced
Received in the Senate.
Source: IntroReferral
9 October 2002
Passed
Motion to reconsider laid on the table Agreed to without objection.
Source: Floor
9 October 2002
Vote
On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 406 - 3 (Roll no. 450). (text: CR 10/7/2002 H7153-7160)
Source: Floor
9 October 2002
Vote
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 406 - 3 (Roll no. 450).(text: CR 10/7/2002 H7153-7160)
Source: Floor
9 October 2002
Floor
Considered as unfinished business. (consideration: CR H7308)
Source: Floor
15 October 2002
Committee
Supplemental report filed by the Committee on Energy and Commerce, H. Rept. 107-728, Part II.
Source: Committee
15 October 2002
Committee
Supplemental report filed by the Committee on Energy and Commerce, H. Rept. 107-728, Part II.
Source: Committee
Votes
No vote records are attached yet.
Versions
- Engrossed in House · 9 October 2002 · Download file
- Reported in House · 7 October 2002 · Download file
- Introduced in House · 20 December 2001 · Download file
Documents
8 official files
Engrossed in House (text)
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Engrossed in House (text)
Engrossed in House · EN · 9 October 2002
Engrossed in House (PDF)
Engrossed in House · EN · 9 October 2002
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Passed House amended
summary · EN · 9 October 2002
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Reported in House (text)
Reported in House · EN · 7 October 2002
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Reported in House (PDF)
Reported in House · EN · 7 October 2002
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Introduced in House (text)
Introduced in House · EN · 20 December 2001
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Introduced in House (PDF)
Introduced in House · EN · 20 December 2001
ViewDownloadOpen at official source
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Introduced in House
summary · EN · 20 December 2001
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Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.
Sponsors
- Rep. Greenwood, James C. [R-PA-8] · R · Sponsor
- Rep. Eshoo, Anna G. [D-CA-18] · D · Sponsor
- Rep. Upton, Fred [R-MI-6] · R · Sponsor
- Rep. Pallone, Frank [D-NJ-6] · D · Sponsor
- Rep. Deutsch, Peter [D-FL-20] · D · Sponsor
- Rep. Towns, Edolphus [D-NY-10] · D · Sponsor
- Rep. Bryant, Ed [R-TN-7] · R · Sponsor
- Rep. Barton, Joe [R-TX-6] · R · Sponsor
- Rep. Pickering, Charles W. "Chip" [R-MS-3] · R · Cosponsor
- Rep. Engel, Eliot L. [D-NY-16] · D · Cosponsor
- Rep. Luther, Bill [D-MN-6] · D · Cosponsor
- Rep. Ramstad, Jim [R-MN-3] · R · Cosponsor
- Rep. Rush, Bobby L. [D-IL-1] · D · Cosponsor
- Rep. Ehrlich, Robert L., Jr. [R-MD-2] · R · Cosponsor
- Rep. Wynn, Albert Russell [D-MD-4] · D · Cosponsor
- Sen. Burr, Richard [R-NC] · R · Cosponsor
- Rep. Roukema, Marge [R-NJ-5] · R · Cosponsor
- Rep. Pitts, Joseph R. [R-PA-16] · R · Cosponsor
- Rep. Whitfield, Ed [R-KY-1] · R · Cosponsor
- Rep. Norwood, Charles W. [R-GA-9] · R · Cosponsor
- Rep. Johnson, Nancy L. [R-CT-5] · R · Cosponsor
- Rep. Hall, Ralph M. [R-TX-4] · D · Cosponsor
- Rep. Ford, Harold E., Jr. [D-TN-9] · D · Cosponsor
- Rep. Kennedy, Mark R. [R-MN-6] · R · Cosponsor
- · hsif00 · Standing
Related records
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.congress.gov/bill/107th-congress/house-bill/3580
- Open data entity: https://api.congress.gov/v3/bill/107/hr/3580
- us · 107-hr-3580 · source updated 7 April 2025