Medical Devices Technical Corrections Act
Public Law 108-214 · S. 1881 · 108th Congress · began in the Senate
Signed by George W. Bush (R) on Apr 1, 2004 · Health
Sponsor: Sen. Lamar Alexander (R-TN)
Cosponsors (3): Sen. Patty Murray, Sen. Michael Enzi,
Passage votesYeaNay
- HouseRecorded vote: 396 yea, 0 nay396–0
- 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 Devices Technical Corrections Act - Amends the Federal Food, Drug, and Cosmetic Act (as amended by the Medical Device User Fee and Modernization Act of 2002) to revise provisions concerning medical devices user fees.
Prohibits the Secretary of Health and Human Services from collecting fees to defray costs in any fiscal year where the amount appropriated is more than five percent below the costs of the resources allocated for the review of device applications.
Allows the Secretary to withdraw accreditation to inspect from any person where the Secretary determines that there is a conflict of interest between the company and the accredited inspector.
Permits a company that markets at least one medical device in the United States and one medical device in another country to use an accredited third party inspector if the company certifies that the foreign country recognizes inspections by: (1) the Food and Drug Administration (FDA); and/or (2) the third party inspector. (Current law requires a country to recognize both types of inspections.)
Allows the Secretary to withdraw eligibility for third party inspections from a company if the Secretary determines that the company is substantially not in compliance with the Act.
Allows electronic labeling for prescription devices intended for use by health care professionals and for in vitro diagnostic devices intended for use by health care professionals or in blood establishments.
Delays by 18 additional months the effective date of the provision deeming a device misbranded if the identification of the manufacturer is not conspicuously displayed.
Directs the Secretary to submit a report to the relevant committees on the barriers to the availability of devices intended for treatment or diagnosis of diseases or conditions that affect children.
Who voted for it
Every House member of the 108th Congress on the ideology compass. Highlighted: the 396 who voted yea on final passage. Faded: everyone else, including those who voted nay, did not vote, or had not yet taken office.
396 yea0 nay38 present or did not vote
Democrats who voted yea(185)
Rep. John ConyersD-MI-14
Rep. Jim McDermottD-WA-7
Rep. Pete StarkD-CA-13
Rep. Maxine WatersD-CA-35
Rep. Barbara LeeD-CA-9
Rep. Bob FilnerD-CA-51
Rep. Jan SchakowskyD-IL-9
Rep. John LewisD-GA-5
Rep. Lynn WoolseyD-CA-6
Rep. George MillerD-CA-7
Rep. Michael CapuanoD-MA-8
Rep. Raúl GrijalvaD-AZ-7
Rep. John OlverD-MA-1
Rep. Alcee HastingsD-FL-23
Rep. James OberstarD-MN-8
Rep. Donald PayneD-NJ-10
Rep. Jesse JacksonD-IL-2
Rep. Tammy BaldwinD-WI-2
Rep. Jim McGovernD-MA-3
Rep. John TierneyD-MA-6
Rep. Barney FrankD-MA-4
Rep. Ed MarkeyD-MA-7
Rep. Diane WatsonD-CA-33
Rep. Nydia VelázquezD-NY-12- Rep. Stephanie JonesD-OH-11
Rep. Ed TownsD-NY-10
Rep. Hilda SolisD-CA-32
Rep. Mel WattD-NC-12
Rep. Bernie SandersD-VT
Rep. Mike HondaD-CA-15
Rep. Peter DeFazioD-OR-4
Rep. Sam FarrD-CA-17
Rep. Linda SánchezD-CA-39
Rep. Bill DelahuntD-MA-10
Rep. Jerrold NadlerD-NY-8
Rep. Louise SlaughterD-NY-28- Rep. Julia CarsonD-IN-7
Rep. Carolyn KilpatrickD-MI-13
Rep. Bennie ThompsonD-MS-2
Rep. Henry WaxmanD-CA-30
Rep. Sherrod BrownD-OH-13
Rep. Charlie RangelD-NY-15
Rep. Nancy PelosiD-CA-8
Rep. Luis GutiérrezD-IL-4
Rep. Bobby RushD-IL-1
Rep. Rush HoltD-NJ-12
Rep. Xavier BecerraD-CA-31
Rep. Tom UdallD-NM-3
Rep. Bobby ScottD-VA-3- Rep. Martin SaboD-MN-5
- Rep. Lane EvansD-IL-17
Rep. Eddie JohnsonD-TX-30
Rep. Rosa DeLauroD-CT-3
Rep. Frank PalloneD-NJ-6
Rep. José SerranoD-NY-16
Rep. Ed PastorD-AZ-4- Rep. Frank BallanceD-NC-1
Rep. Diana DeGetteD-CO-1- Rep. Jerry KleczkaD-WI-4
Rep. Chaka FattahD-PA-2
Rep. Grace NapolitanoD-CA-38
Rep. Lucille Roybal-AllardD-CA-34
Rep. Jim ClyburnD-SC-6- Rep. Juanita Millender-McDonaldD-CA-37
Rep. John LarsonD-CT-1
Rep. Earl BlumenauerD-OR-3
Rep. Lois CappsD-CA-23
Rep. Richard NealD-MA-2
Rep. Dave ObeyD-WI-7
Rep. Marcy KapturD-OH-9
Rep. Tom AllenD-ME-1
Rep. Betty McCollumD-MN-4
Rep. Corrine BrownD-FL-3- Rep. Ted StricklandD-OH-6
Rep. Robert BradyD-PA-1
Rep. Gary AckermanD-NY-5- Rep. Marty MeehanD-MA-5
Rep. Tim RyanD-OH-17
Rep. Robert WexlerD-FL-19
Rep. Chris Van HollenD-MD-8
Rep. Anthony WeinerD-NY-9
Rep. Brad ShermanD-CA-27
Rep. Carolyn MaloneyD-NY-14
Rep. Peter ViscloskyD-IN-1- Rep. Karen McCarthyD-MO-5
Rep. Brian BairdD-WA-3
Rep. John DingellD-MI-15
Rep. Anna EshooD-CA-14
Rep. Neil AbercrombieD-HI-1
Rep. Loretta SanchezD-CA-47- Rep. Tom LantosD-CA-12
- Rep. Robert MatsuiD-CA-5
Rep. Bart StupakD-MI-1
Rep. Rahm EmanuelD-IL-5
Rep. William JeffersonD-LA-2
Rep. Howard BermanD-CA-28
Rep. Rob AndrewsD-NJ-1
Rep. Michael McNultyD-NY-21
Rep. Kendrick MeekD-FL-17
Rep. Jay InsleeD-WA-1
Rep. Eliot EngelD-NY-17
Rep. Mike ThompsonD-CA-1
Rep. Rick LarsenD-WA-2
Rep. Gregory MeeksD-NY-6
Rep. Dale KildeeD-MI-5- Rep. Denise MajetteD-GA-4
Rep. Jim LangevinD-RI-2
Rep. Bill PascrellD-NJ-8
Rep. Steny HoyerD-MD-5
Rep. Sander LevinD-MI-12
Rep. Timothy BishopD-NY-1
Rep. Brad MillerD-NC-13
Rep. Steven RothmanD-NJ-9
Rep. Bob MenendezD-NJ-13
Rep. Joe CrowleyD-NY-7- Rep. Harold FordD-TN-9
- Rep. Joseph HoeffelD-PA-13
Rep. Nita LoweyD-NY-18
Rep. Michael DoyleD-PA-14- Rep. Peter DeutschD-FL-20
Rep. Nick RahallD-WV-3
Rep. Gene GreenD-TX-29
Rep. Nick LampsonD-TX-9
Rep. Shelley BerkleyD-NV-1
Rep. Stephen LynchD-MA-9
Rep. Ellen TauscherD-CA-10
Rep. David WuD-OR-1
Rep. Joe BacaD-CA-43
Rep. Marion BerryD-AR-1
Rep. Jerry CostelloD-IL-12
Rep. Susan DavisD-CA-53- Rep. Albert WynnD-MD-4
Rep. Benjamin CardinD-MD-3
Rep. Carolyn McCarthyD-NY-4
Rep. Michael MichaudD-ME-2
Rep. Paul KanjorskiD-PA-11- Rep. Martin FrostD-TX-24
Rep. David PriceD-NC-4
Rep. Norm DicksD-WA-6
Rep. Artur DavisD-AL-7
Rep. Bob EtheridgeD-NC-2
Rep. Jane HarmanD-CA-36
Rep. John SprattD-SC-5
Rep. Steve IsraelD-NY-2
Rep. Darlene HooleyD-OR-5- Rep. Jim DavisD-FL-11
Rep. Alan MollohanD-WV-1
Rep. A. Dutch RuppersbergerD-MD-2
Rep. Ron KindD-WI-3
Rep. Mike RossD-AR-4- Rep. Max SandlinD-TX-1
Rep. Baron HillD-IN-9
Rep. Jim CooperD-TN-5
Rep. Leonard BoswellD-IA-3
Rep. Dennis MooreD-KS-3
Rep. Vic SnyderD-AR-2
Rep. Adam SmithD-WA-9
Rep. John TannerD-TN-8
Rep. Dennis CardozaD-CA-18
Rep. Mike McIntyreD-NC-7
Rep. Ed CaseD-HI-2
Rep. Earl PomeroyD-ND
Rep. Rick BoucherD-VA-9
Rep. Ben ChandlerD-KY-6
Rep. David ScottD-GA-13
Rep. Tim HoldenD-PA-17
Rep. Ike SkeltonD-MO-4- Rep. Jim TurnerD-TX-2
Rep. John MurthaD-PA-12- Rep. William LipinskiD-IL-3
Rep. Chet EdwardsD-TX-11
Rep. Bart GordonD-TN-6- Rep. Cal DooleyD-CA-20
- Rep. Brad CarsonD-OK-2
Rep. Lincoln DavisD-TN-4
Rep. Gene TaylorD-MS-4
Rep. Jim MarshallD-GA-3
Rep. Allen BoydD-FL-2
Rep. Jim MathesonD-UT-2- Rep. Chris JohnD-LA-7
Rep. Collin PetersonD-MN-7- Rep. Charlie StenholmD-TX-17
- Rep. Ken LucasD-KY-4
Rep. Rodney AlexanderD-LA-5
Rep. Bud CramerD-AL-5
Republicans who voted yea(211)
- Rep. Jim LeachR-IA-2
Rep. Michael CastleR-DE
Rep. Christopher ShaysR-CT-4
Rep. Timothy JohnsonR-IL-15- Rep. Doug BereuterR-NE-1
- Rep. Rob SimmonsR-CT-2
- Rep. Sherry BoehlertR-NY-24
Rep. Chris SmithR-NJ-4
Rep. Heather WilsonR-NM-1
Rep. Frank LoBiondoR-NJ-2
Rep. John McHughR-NY-23
Rep. Fred UptonR-MI-6- Rep. Jack QuinnR-NY-27
Rep. Ray LaHoodR-IL-18- Rep. Sue KellyR-NY-19
Rep. Jim SaxtonR-NJ-3
Rep. Shelley CapitoR-WV-2- Rep. Curt WeldonR-PA-7
- Rep. Amo HoughtonR-NY-29
Rep. Pete KingR-NY-3
Rep. Jon PorterR-NV-3
Rep. Jim GerlachR-PA-6
Rep. Vernon EhlersR-MI-3
Rep. Jo Ann EmersonR-MO-8
Rep. Mike FergusonR-NJ-7- Rep. Nancy JohnsonR-CT-5
Rep. Frank WolfR-VA-10
Rep. Phil EnglishR-PA-3
Rep. Jim WalshR-NY-25
Rep. Tom LathamR-IA-4
Rep. Richard BurrR-NC-5
Rep. Rodney FrelinghuysenR-NJ-11
Rep. Rick RenziR-AZ-1
Rep. Todd PlattsR-PA-19- Rep. Bob NeyR-OH-18
- Rep. George NethercuttR-WA-5
Rep. Mary Bono MackR-CA-45
Rep. Mark KirkR-IL-10- Rep. Clay ShawR-FL-22
Rep. Ed WhitfieldR-KY-1
Rep. Tom DavisR-VA-11
Rep. Greg WaldenR-OR-2
Rep. Ileana Ros-LehtinenR-FL-18
Rep. Ralph RegulaR-OH-16
Rep. Dave HobsonR-OH-7- Rep. Tom OsborneR-NE-3
Rep. Tim MurphyR-PA-18
Rep. Candice MillerR-MI-10
Rep. Ken CalvertR-CA-44
Rep. Wayne GilchrestR-MD-1- Rep. Paul GillmorR-OH-5
- Rep. Jeb BradleyR-NH-1
Rep. John PetersonR-PA-5
Rep. Lincoln Diaz-BalartR-FL-21- Rep. Mark FoleyR-FL-16
Rep. Chip PickeringR-MS-3
Rep. Thad McCotterR-MI-11
Rep. Deborah PryceR-OH-15- Rep. Anne NorthupR-KY-3
Rep. Michael TurnerR-OH-3
Rep. Jerry LewisR-CA-41- Rep. Don SherwoodR-PA-10
Rep. Jerry WellerR-IL-11
Rep. Judy BiggertR-IL-13
Rep. W. Bill YoungR-FL-10- Rep. Jim KolbeR-AZ-8
Rep. Mike RogersR-AL-3
Rep. Don YoungR-AK- Rep. Henry HydeR-IL-6
Rep. Joe KnollenbergR-MI-9
Rep. Mike SimpsonR-ID-2
Rep. Ander CrenshawR-FL-4
Rep. Dave CampR-MI-4- Rep. Doug OseR-CA-3
Rep. Hal RogersR-KY-5
Rep. Frank LucasR-OK-3
Rep. Ginny Brown-WaiteR-FL-5
Rep. Rob PortmanR-OH-2
Rep. Henry BrownR-SC-1- Rep. Jim NussleR-IA-1
- Rep. Max BurnsR-GA-12
- Rep. Porter GossR-FL-14
Rep. Darrell IssaR-CA-49
Rep. Elton GalleglyR-CA-24- Rep. Duke CunninghamR-CA-50
- Rep. Bill ThomasR-CA-22
Rep. Robert AderholtR-AL-4- Rep. Henry BonillaR-TX-23
Rep. Buck McKeonR-CA-25
Rep. David DreierR-CA-26
Rep. Jerry MoranR-KS-1
Rep. Zach WampR-TN-3
Rep. Devin NunesR-CA-21
Rep. Lamar SmithR-TX-21
Rep. Denny RehbergR-MT- Rep. Jennifer DunnR-WA-8
Rep. Mike RogersR-MI-8
Rep. John BoozmanR-AR-3
Rep. John MicaR-FL-7- Rep. Michael OxleyR-OH-4
Rep. Bill ShusterR-PA-9
Rep. Tom ColeR-OK-4
Rep. Thomas ReynoldsR-NY-26
Rep. Spencer BachusR-AL-6
Rep. Charlie BassR-NH-2
Rep. Kenny HulshofR-MO-9
Rep. Steve PearceR-NM-2- Rep. Cass BallengerR-NC-10
- Rep. Bill JenkinsR-TN-1
Rep. Jo BonnerR-AL-1
Rep. Ron LewisR-KY-2
Rep. Doc HastingsR-WA-4- Rep. Michael BilirakisR-FL-9
Rep. Robin HayesR-NC-8
Rep. Adam PutnamR-FL-12
Rep. Pat TiberiR-OH-12
Rep. Jim McCreryR-LA-4
Rep. Mark SouderR-IN-3
Rep. Duncan HunterR-CA-52- Rep. Richard PomboR-CA-11
- Rep. Jo Ann DavisR-VA-1
- Rep. Richard BakerR-LA-6
Rep. Steve BuyerR-IN-4- Rep. Katherine HarrisR-FL-13
Rep. Virgil GoodeR-VA-5
Rep. Randy ForbesR-VA-4- Rep. Charles TaylorR-NC-11
Rep. Todd TiahrtR-KS-4
Rep. Dave WeldonR-FL-15
Rep. John DoolittleR-CA-4
Rep. John BoehnerR-OH-8
Rep. George RadanovichR-CA-19- Rep. Ernest IstookR-OK-5
- Rep. Melissa HartR-PA-4
Rep. Roy BluntR-MO-7
Rep. Walter JonesR-NC-3
Rep. John ShimkusR-IL-19
Rep. Dan BurtonR-IN-5
Rep. Bob GoodlatteR-VA-6
Rep. Jim RamstadR-MN-3- Rep. Ed SchrockR-VA-2
Rep. Sam GravesR-MO-6
Rep. John KlineR-MN-2
Rep. Phil GingreyR-GA-11- Rep. Tom DeLayR-TX-22
- Rep. Mark GreenR-WI-8
Rep. Ric KellerR-FL-8
Rep. Terry EverettR-AL-2- Rep. Jim RyunR-KS-2
Rep. Eric CantorR-VA-7
Rep. John SullivanR-OK-1
Rep. David VitterR-LA-1
Rep. Lee TerryR-NE-2- Rep. Scott McInnisR-CO-3
- Rep. Jim GibbonsR-NV-2
Rep. Donald ManzulloR-IL-16
Rep. Rob BishopR-UT-1- Rep. Bob BeauprezR-CO-7
Rep. Jack KingstonR-GA-1
Rep. Pete HoekstraR-MI-2
Rep. Johnny IsaksonR-GA-6- Rep. J.D. HayworthR-AZ-5
- Rep. Mark KennedyR-MN-6
- Rep. Chris ChocolaR-IN-2
Rep. Tom PetriR-WI-6
Rep. John CulbersonR-TX-7
Rep. John LinderR-GA-7
Rep. Gary MillerR-CA-42
Rep. Mac ThornberryR-TX-13
Rep. Randy NeugebauerR-TX-19
Rep. Michael BurgessR-TX-26
Rep. Joe WilsonR-SC-2- Rep. Gil GutknechtR-MN-1
Rep. Kevin BradyR-TX-8
Rep. Joseph PittsR-PA-16
Rep. Howard CobleR-NC-6
Rep. Steve ChabotR-OH-1
Rep. Paul RyanR-WI-1
Rep. Barbara CubinR-WY
Rep. Marsha BlackburnR-TN-7
Rep. Wally HergerR-CA-2
Rep. Pete SessionsR-TX-32
Rep. Chris CannonR-UT-3- Rep. Charlie NorwoodR-GA-9
Rep. Mac CollinsR-GA-8
Rep. Jim DeMintR-SC-4
Rep. Sue MyrickR-NC-9
Rep. Nathan DealR-GA-10- Rep. John HostettlerR-IN-8
Rep. Steve KingR-IA-5
Rep. Marilyn MusgraveR-CO-4
Rep. Todd AkinR-MO-2
Rep. J. Gresham BarrettR-SC-3
Rep. Jimmy DuncanR-TN-2- Rep. Nick SmithR-MI-7
Rep. Scott GarrettR-NJ-5
Rep. Cliff StearnsR-FL-6
Rep. Mike PenceR-IN-6
Rep. Tom FeeneyR-FL-24- Rep. Joel HefleyR-CO-5
Rep. Dana RohrabacherR-CA-46
Rep. Jeb HensarlingR-TX-5
Rep. Tom TancredoR-CO-6
Rep. Ed RoyceR-CA-40
Rep. Roscoe BartlettR-MD-6- Rep. Butch OtterR-ID-1
Rep. James SensenbrennerR-WI-5
Rep. John ShadeggR-AZ-3
Rep. Trent FranksR-AZ-2
Rep. Ron PaulR-TX-14
Rep. Jeff FlakeR-AZ-6
Data notes
The House’s recorded vote on the final version of the law (roll call 720 in Voteview), matched to the vote the record cites and checked against its totals. Positions are each member’s DW-NOMINATE score for that Congress, as on the Ideology page; left to right is more liberal to more conservative. Paired and announced yea votes count as yea. Lists follow the compass, most liberal first. A name links to a profile only for members of the current Congress. A law passed by voice vote or unanimous consent has no member list, and neither does a vote Voteview has not yet recorded.
Committees
The committees the bill was sent to, and what each did with it.
Energy and Commerce Committee · House · markup by, referred to, reported bySubcommittee: 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.
H.R. 3493Related bill
Medical Devices Technical Corrections Act
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. 28 actions.
- Apr 1, 2004Became lawBecame law · Became Public Law No: 108-214.
- Became lawBecame law · Signed by President.
- Mar 22, 2004FloorFloor · Presented to President.
- Mar 15, 2004FloorFloor · Message on Senate action sent to the House.
- Mar 12, 2004Resolving differencesResolving differences · Senate agreed to House amendment by Unanimous Consent.
- OtherOther · Resolving differences -- Senate actions: Senate agreed to House amendment by Unanimous Consent.
- Mar 11, 2004FloorFloor · Message on House action received in Senate and at desk: House amendment to Senate bill.
- Mar 10, 2004FloorFloor · Motion to reconsider laid on the table Agreed to without objection.
- FloorFloor · On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 396 - 0 (Roll no. 46).House roll call 46
- FloorFloor · Considered as unfinished business.
- Mar 9, 2004FloorFloor · 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.
- FloorFloor · DEBATE - The House proceeded with forty minutes of debate on S. 1881.
- FloorFloor · Considered under suspension of the rules.
- FloorFloor · Mr. Greenwood moved to suspend the rules and pass the bill, as amended.
- CalendarCalendar · Placed on the Union Calendar, Calendar No. 250.
- CommitteeCommittee · Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 108-433.
- Mar 3, 2004CommitteeCommittee · Ordered to be Reported (Amended) by Voice Vote.
- CommitteeCommittee · Committee Consideration and Mark-up Session Held.
- Dec 17, 2003CommitteeCommittee · Referred to the Subcommittee on Health.
- Dec 8, 2003FloorFloor · Message on Senate action sent to the House.
- FloorFloor · Received in the House.
- CommitteeCommittee · Referred to the House Committee on Energy and Commerce.
- Nov 25, 2003FloorFloor · Passed Senate with an amendment by Unanimous Consent.
- Nov 24, 2003CalendarCalendar · Placed on Senate Legislative Calendar under General Orders. Calendar No. 412.
- CommitteeCommittee · Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment in the nature of a substitute. Without written report.
- Nov 21, 2003CommitteeCommittee · Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- Nov 18, 2003CommitteeCommittee · Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- IntroducedIntroduced · Introduced in Senate
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.