Medical Devices Technical Corrections Act

Summary

Medical Devices Technical Corrections Act of 2003 - Amends the Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device User Fee and Modernization Act of 2002, to revise medical device fee schedule provisions. Revises facility inspection and accredited inspector provisions, including permitting a company that markets at least one medical device in the United States and one medical device in another country to satisfy inspection requirements by: (1) certifying that a foreign country recognizes Food and Drug Administration (FDA) inspection; and/or (2) marketing its devices in a country that recognizes third party inspectors. (Current law requires a company to meet both requirements.) Eliminates the provision deeming a device introduced into interstate commerce within 18 months of enactment of the Medical Device User Fee and Modernization Act of 2002 (October 26, 2002) to be misbranded if the identification of the manufacturer is not conspicuously displayed. Requires (currently authorizes) the Secretary of Health and Human Services to conduct or support research on the long-term effects of silicone breast implants. Permits a person to sell a device under the humanitarian exemption from certain effectiveness requirements for more than its research, fabrication, and distribution costs if such device is intended for pediatric treatment or diagnosis. (Defines "pediatric patient" as a patient under 15 years old at the time of treatment or diagnosis.)

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Timeline

1. 17 November 2003

   Introduced

   Introduced in House

   Source: IntroReferral

2. 17 November 2003

   Introduced

   Introduced in House

   Source: IntroReferral

3. 17 November 2003

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

4. 4 December 2003

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

5. 27 January 2004

   Passed

   Motion to reconsider laid on the table Agreed to without objection.

   Source: Floor

6. 27 January 2004

   Vote

   On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 333 - 0 (Roll no. 7). (CR H109-110)

   Source: Floor

7. 27 January 2004

   Vote

   Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 333 - 0 (Roll no. 7).(CR H109-110)

   Source: Floor

8. 27 January 2004

   Floor

   Considered under suspension of the rules. (consideration: CR H109-112)

   Source: Floor

9. 27 January 2004

   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.

   Source: Floor

10. 27 January 2004

    Floor

    DEBATE - The House proceeded with forty minutes of debate on H.R. 3493.

    Source: Floor

11. 27 January 2004

    Floor

    Mr. Greenwood moved to suspend the rules and pass the bill.

    Source: Floor

12. 28 January 2004

    Introduced

    Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

    Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Referred in Senate · 28 January 2004 · Official file
• Engrossed in House · 27 January 2004 · Official file
• Introduced in House · 17 November 2003 · Official file

Documents

8 official files

• Referred in Senate (text)

  Referred in Senate · EN · 28 January 2004

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• Referred in Senate (PDF)

  Referred in Senate · EN · 28 January 2004

  ViewDownloadOpen at official source

• Engrossed in House (text)

  Engrossed in House · EN · 27 January 2004

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• Engrossed in House (PDF)

  Engrossed in House · EN · 27 January 2004

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• Passed House without amendment

  summary · EN · 27 January 2004

  Open at official source

• Introduced in House (text)

  Introduced in House · EN · 17 November 2003

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 17 November 2003

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 17 November 2003

  Open at official source

Sponsors

• Rep. Greenwood, James C. [R-PA-8] · R · Sponsor
• Anna Eshoo · D · Sponsor
• · sshr00 · Standing
• · hsif00 · Standing

Related records

• related to ← Medical Devices Technical Corrections Act