H.R. 3493 (108th): Medical Devices Technical Corrections Act

Nov 17, 2003 (108th Congress, 2003–2004)
Died (Passed House)
See Instead:

S. 1881 (same title)
Signed by the President — Apr 01, 2004

James “Jim” Greenwood
Representative for Pennsylvania's 8th congressional district
Read Text »
Last Updated
Jan 28, 2004
17 pages
Related Bills
S. 1881 (Related)
Medical Devices Technical Corrections Act

Signed by the President
Apr 01, 2004


This bill was introduced in a previous session of Congress and was passed by the House on January 27, 2004 but was never passed by the Senate.

Introduced Nov 17, 2003
Referred to Committee Nov 17, 2003
Passed House Jan 27, 2004
Full Title

To amend the Federal Food, Drug, and Cosmetic Act to make technical corrections relating to the amendments made by the Medical Device User Fee and Modernization Act of 2002, and for other purposes.


No summaries available.

On Motion to Suspend the Rules and Pass, as Amended
Jan 27, 2004 7:13 p.m.
Passed 333/0

1 cosponsors (1D) (show)

House Energy and Commerce


Senate Health, Education, Labor, and Pensions

The committee chair determines whether a bill will move past the committee stage.

Primary Source

THOMAS.gov (The Library of Congress)

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H.R. stands for House of Representatives bill.

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GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

1/27/2004--Passed House without amendment.
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 the accreditation to inspect from any person where the Secretary has information indicating a relationship between the company and the accredited inspector that may create a conflict of interest.
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 obtains information indicating significant deviations from compliance with the Act or implementing regulations.
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.

House Republican Conference Summary

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No summary available.

House Democratic Caucus Summary

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