Medical Device User Fee Stabilization Act of 2005
Public Law 109-43 · H.R. 3423 · 109th Congress · began in the House
Signed by George W. Bush (R) on Aug 1, 2005 · Health
Sponsor: Rep. Joseph Pitts (R-PA-16)
Cosponsors (10): Rep. Anna Eshoo, Rep. Mary Bono Mack,
Passage votes
- HouseUnanimous consent
- SenateUnanimous consent
Data notes
The final version of the law, as each chamber passed it. A chamber that passed it by voice vote or unanimous consent has no count. “Method not stated” means the record does not say how the chamber voted. Where the record has a member-by-member vote, the “Who voted for it” section shows who voted yea.
Summary
The Congressional Research Service’s plain-language summary of what the law does.
Medical Device User Fee Stabilization Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act to adjust medical device user fees (e.g., premarket application, premarket report, supplement, and submission fees).
Repeals the fee revenue target amounts for FY2006 and FY2007.
Eliminates the inflation, workload, compensating, and final year adjustments of revenues used for setting fees.
Sets the premarket application fee for devices for FY2006 and FY2007.
Allows the Secretary of Health and Human Services to use unobligated carryover balances from fees collected in previous fiscal years with notice to the appropriate congressional committees.
Increases the annual gross receipts or sales threshold below which businesses are eligible for reduced fees or a waiver of fees by the Secretary.
Removes the prohibition against the Secretary assessing fees unless certain cumulative fee revenues were met for FY2003 through 2006.
Requires the Secretary to include in annual reports to Congress: (1) information on the number and total amount of fees paid for each different type of application or notification from small businesses; and (2) a certification that the amounts obligated for the performance of functions other than the review of device applications is not less than such amount for FY2002 multiplied by the adjustment factor.
Deems as branded any reprocessed single use device unless it identifies the manufacturer, but allows such information to be provided by a detachable label intended to be affixed to the medical record of a patient.
Committees
The committees the bill was sent to, and what each did with it.
Energy and Commerce Committee · House · discharged from, referred toSubcommittee: Health Subcommittee
Data notes
A committee links to its page only where it exists in the current Congress; older and renamed committees are named without a link.
Related bills
1 bill the Library of Congress relates to this one.
S. 1420Related bill
Medical Device User Fee Stabilization Act of 2005
Data notes
Related bills are identified by the Congressional Research Service, the House and the Senate: companion and identical bills, bills with similar text, bills that were folded into this law, and rules that brought it to the floor. A bill that is itself a public law in this site’s data links here; the others link to Congress.gov.
Timeline
From introduction to signing, newest first: the committees, the floor and the president. 14 actions.
- Aug 1, 2005Became lawBecame law · Became Public Law No: 109-43.
- Became lawBecame law · Signed by President.
- Jul 29, 2005FloorFloor · Presented to President.
- CommitteeCommittee · Referred to the Subcommittee on Health.
- Jul 28, 2005FloorFloor · Message on Senate action sent to the House.
- Jul 27, 2005FloorFloor · Received in the Senate, read twice, considered, read the third time, and passed without amendment by Unanimous Consent.
- OtherOther · Cleared for White House.
- Jul 26, 2005FloorFloor · Motion to reconsider laid on the table Agreed to without objection.
- FloorFloor · On passage Passed without objection.
- FloorFloor · Mr. Deal (GA) asked unanimous consent to discharge from committee and consider.
- FloorFloor · Considered by unanimous consent.
- CommitteeCommittee · Committee on Energy and Commerce discharged.
- Jul 25, 2005CommitteeCommittee · Referred to the House Committee on Energy and Commerce.
- IntroducedIntroduced · Introduced in House
Data notes
Every action the Library of Congress lists for the bill, from introduction to signing, plus the dated committee hearings. The source lists many steps twice (the chamber’s own entry and the Library of Congress copy, or a presidential and a became-law entry with the same words); those are shown once. Amendments are listed in their own section.
Amendments
No amendments to this bill are on record.
Data notes
Amendments offered to this bill in either chamber, as the Library of Congress records them: each with a status read from its last recorded step: agreed to, rejected, withdrawn, ruled out of order, fell with another amendment, or offered with no vote recorded (most Senate amendments are only ever offered). The wording of each amendment is the source’s. Amendments to amendments and amendments to other bills are not listed.
Official record
The bill’s full text is on Congress.gov. Data through Oct 7, 2026.