S. 1881 (108th): Medical Devices Technical Corrections Act

Nov 18, 2003 (108th Congress, 2003–2004)
Signed by the President
Slip Law:
This bill became Pub.L. 108-214.
Lamar Alexander
Senator from Tennessee
Read Text »
Last Updated
Mar 12, 2004
7 pages
Related Bills
H.R. 3493 (Related)
Medical Devices Technical Corrections Act

Passed House
Last Action: Jan 27, 2004


This bill was enacted after being signed by the President on April 1, 2004.

Introduced Nov 18, 2003
Referred to Committee Nov 18, 2003
Reported by Committee Nov 21, 2003
Passed Senate Nov 25, 2003
Passed House with Changes Mar 10, 2004
Senate Agreed to Changes Mar 12, 2004
Signed by the President Apr 01, 2004
Full Title

A bill to amend the Federal Food, Drug, and Cosmetic Act to make technical corrections relating to the amendments 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
Mar 10, 2004 10:49 a.m.
Passed 396/0

3 cosponsors (2R, 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)

GovTrack gets most information from THOMAS, which is updated generally one day after events occur. Activity since the last update may not be reflected here. Data comes via the congress project.


Get a bill status widget for your website »


Click a format for a citation suggestion:


S. stands for Senate bill.

A bill must be passed by both the House and Senate in identical form and then be signed by the president to become law.

GovTrack’s Bill Summary

We don’t have a summary available yet.

Library of Congress Summary

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

4/1/2004--Public Law.
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.

House Republican Conference Summary

The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.

No summary available.

House Democratic Caucus Summary

The House Democratic Caucus does not provide summaries of bills.

So, yes, we display the House Republican Conference’s summaries when available even if we do not have a Democratic summary available. That’s because we feel it is better to give you as much information as possible, even if we cannot provide every viewpoint.

We’ll be looking for a source of summaries from the other side in the meanwhile.

Use the comment space below for discussion of the merits of S. 1881 (108th) with other GovTrack users.
Your comments are not read by Congressional staff.

comments powered by Disqus